BioNTech
NasdaqGS:BNTX
$
96,25
$
$-0,48 (-0,50%)
96,25
$
$-0,48 (-0,50%)
End-of-day quote: 12/05/2025
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BioNTech Company Info
EPS Growth 5Y
-27,55%
Market Cap
$23,26 B
Long-Term Debt
$0,00 B
Annual earnings
03/10/2026
Dividend
$0,00
Dividend Yield
0,00%
Founded
2008
Industry
Country
Website
ISIN Number
Website
Analyst Price Target
$140,65
46.13%
Last Update: 12/06/2025
Analysts: 19
Highest Price Target $173,09
Average Price Target $140,65
Lowest Price Target $101,35
In the last five quarters, BioNTech’s Price Target has risen from $121,76 to $139,38 - a 14,47% increase. Eighteen analysts predict that BioNTech’s share price will increase in the coming year, reaching $140,65. This would represent an increase of 46,13%.
Top growth stocks in the health care sector (5Y.)
What does BioNTech do?
BioNTech SE operates as a next-generation immunotherapy company pioneering novel medicines against cancer, infectious diseases and other serious diseases.
The company’s fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science, artificial intelligence, or AI, and machine learning, or ML, capabilities to discover,...
BioNTech SE operates as a next-generation immunotherapy company pioneering novel medicines against cancer, infectious diseases and other serious diseases.
The company’s fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing, translational drug discovery, clinical development, commercial capabilities, computational medicine, data science, artificial intelligence, or AI, and machine learning, or ML, capabilities to discover, develop, and commercialize its marketed products and product candidates.
The company has built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes investigational messenger ribonucleic acid, or mRNA immunotherapies, protein-based therapeutics (including targeted antibodies, such as monoclonal, bispecific, and antibody-drug conjugates, or ADCs), and cell therapies.
The company’s multi-technology combination of platforms and product candidates positions it as a pioneer in the field of individualized, patient-centric therapeutic approaches in oncology and infectious diseases.
The company’s primary focus is oncology, where it endeavors to address the full continuum of cancer from early to late disease stages. To augment anti-tumor activity and to counteract resistance mechanisms, it seeks to combine compounds with non-overlapping, synergistic mechanisms of action.
Oncology Pipeline Strategy
mRNA Cancer Immunotherapies: The company is developing a portfolio of mRNA-based therapeutic candidates to treat cancer: cancer immunotherapies, including FixVac (fully owned) and iNeST (in collaboration with Genentech, Inc., a member of the Roche Group, or Genentech), and mRNA-encoded cytokines and antibodies.
Immunomodulators: The company is building a modality-agnostic toolkit to focus on crucial immuno-oncology pathways. It targets different but complementary players in the complex cancer immunity cycle to promote a thorough and durable antitumor effect. It uses its in-house capabilities and collaborates with Genmab A/S, or Genmab, and OncoC4, Inc., or OncoC4, to develop next-generation immunomodulators that are designed to modulate the patient’s immune response to cancer.
Targeted Therapies: The company collaborates with Duality Biologics (Suzhou) Co. Ltd., or DualityBio, and MediLink Therapeutics (Suzhou) Co., Ltd., or MediLink Therapeutics, to develop next-generation ADCs. ADCs will transform cancer care. The company is also developing a range of cell therapies against solid tumors, including chimeric antigen receptor, or CAR-T, cell therapies, neoantigen-based T-cell therapies, and T-cell receptor, or TCR, therapies, in which the patient’s T cells are modified or primed to target cancer-specific antigens.
From the company’s diverse clinical portfolio, it has identified two high-priority assets with pan-tumor potential and programs.
The company plans to continue building its oncology pipeline and commercial capabilities in 2025 in anticipation of potential commercial oncology launches as soon as 2026, if approved.
Infectious Disease Pipeline Strategy
The company has pursued both strategic partnerships and corporate collaborations to partially fund its infectious disease global health programs and aims to continue to do so. The company’s infectious disease programs aim to contribute to equitable access to effective and well-tolerated vaccines for high medical need indications.
Together with its collaborator Pfizer Inc., or Pfizer, the company plans to continue to invest in the research and development of next-generation COVID-19 vaccines and COVID-19/influenza combination vaccines. It expects seasonal COVID-19 vaccination to continue, driven by the continuous evolution of the virus.
The company and its partners are also committed to researching and developing product candidates against latent viruses, including herpes-simplex virus, or HSV, varicella-zoster virus, or shingles, and mpox. Latent viruses remain in the body after an infection and can lead to lifelong medical complications. In addition, the company has ongoing trials evaluating mRNA vaccine candidates against diseases caused by bacteria (tuberculosis) and parasites (malaria).
Strategic Outlook
The company is committed to translating science into survival for patients by advancing BioNTech’s strategy and executing it to become a global immunotherapy powerhouse with multiple approved products and revenue streams.
As part of this continued approach, the company has built a unique pipeline by targeting technologies and candidates with disruptive potential. In oncology, it focuses on therapeutic approaches with pan-tumor potential, including its personalized mRNA cancer immunotherapies and its bispecific antibody candidate BNT327. The company plans to significantly invest in its broad clinical evaluation across multiple cancer indications with significant (unmet) medical needs, as well as its commercialization in key markets.
As it continues to invest in executing its vision, the company remains committed to cost-effective value generation. It actively manages its pipeline and assesses its sites according to key criteria: strategic alignment, operational efficiency, and sustainable value creation. Consequently, the company plans to significantly invest in essential areas while optimizing capacities in others.
Marketed Products: Comirnaty, The company’s COVID-19 Vaccine Program (BNT162)
The company’s commercial product, Comirnaty, was the first-ever approved mRNA-based product and, to its knowledge, represents the fastest ever developed prophylactic vaccine from viral sampling to approval. As of December 2024, the company’s COVID-19 vaccine products had been authorized or approved for emergency or temporary use or granted marketing authorization in more than 180 countries and regions worldwide. The company’s efforts have resulted in more than 4.9 billion doses shipped globally.
Under the company’s collaboration with Pfizer, it is the Marketing Authorization Holder in the United States, the European Union, or EU, the UK, Canada, and other countries. Additionally, it is the holder of emergency use authorizations, or EUAs, or equivalents in the United States (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide apart from Greater China, Germany, and Türkiye. The company has the marketing and distribution rights to Comirnaty in Germany and Türkiye.
Under the company’s collaboration with Fosun Pharma, Fosun Pharma has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR, and Taiwan.
Commercial Update
In 2024, the company and Pfizer continued their global COVID-19 vaccine leadership with their Omicron JN.1 and Omicron KP.2-adapted monovalent COVID-19 vaccines directed against the Omicron JN.1 and Omicron KP.2 variants, respectively. Since the declaration of the pandemic, the company has developed and commercialized six COVID-19 vaccine products: the original COVID-19 vaccine, two Original/Omicron-adapted bivalent vaccines (Original/BA.1- and Original/Omicron BA.4-5-adapted bivalent vaccines), the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, and the Omicron JN.1 and Omicron KP.2 monovalent COVID-19 vaccines. Each is referred to as Comirnaty. Between December 2020 and March 2023, COVID-19 vaccination programs across 34 World Health Organization, or WHO, European Region countries prevented an estimated 1.6 million deaths. In the first two years of the COVID-19 vaccine being available in the United States, the country’s vaccination program is estimated to have prevented more than 18 million additional hospitalizations and more than 3 million additional deaths.
In August 2024, following regulatory approvals, the company and Pfizer began distribution of their Omicron KP.2 variant-adapted vaccine in the United States. The KP.2 adaptation is based on guidance from the U.S. Food and Drug Administration, or FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the United States during the 2024-2025 fall and winter season, if feasible.
In September 2024, following regulatory approvals, the company and Pfizer began distribution of their Omicron KP.2 variant-adapted vaccine in Europe following the initial rollout of their Omicron JN.1 variant-adapted vaccine in July 2024.
Manufacturing and Distribution
The company and Pfizer have established an efficient and robust global vaccine supply chain and manufacturing network capable of meeting global demand.
In 2024, the company continued transitioning from an advanced purchase agreement framework to commercial market ordering in some geographies, including the UK, Japan, Switzerland, Australia, South Korea, Singapore, and Brazil.
The company and Pfizer have an ongoing COVID-19 Vaccine Purchase Agreement with the European Commission, or the EC, to deliver COVID-19 vaccines to the EU. The agreement reflects the company’s and Pfizer’s commitment to working collaboratively to help address ongoing public health needs. The 2023 agreement rephased delivery of doses annually through 2026. In addition, the agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.
Clinical Development
Omicron JN.1 and Omicron KP.2-adapted monovalent COVID-19 Vaccines
The Omicron JN.1 sublineages currently account for the majority of COVID-19 cases globally and are antigenically distant from previously circulating SARS-CoV-2 lineages, including Omicron XBB.1.5, Omicron BA.4-5, and the original SARS-CoV-2 strain. Although Omicron XBB.1.5-adapted monovalent vaccines provided some protection against a range of outcomes from JN.1-related COVID-19 disease, evidence suggests that vaccines better matched to currently circulating sublineages would provide improved protection against symptomatic and severe COVID-19 disease.
The company’s and Pfizer’s regulatory filings have been based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccines. The submissions included manufacturing and non-clinical data showing that the JN.1- and KP.2-adapted monovalent vaccines elicited a markedly improved immune response against multiple Omicron JN.1 sublineages, such as KP.3.1.1, or LB.1 and other currently circulating variants, when compared with the Omicron XBB.1.5-adapted monovalent vaccine.
Clinical immunogenicity data demonstrated that the Omicron JN.1-adapted vaccine induces a strong and broad neutralizing antibody response across multiple JN.1 sublineages, including XEC.
Early vaccine effectiveness data from a nationwide test-negative case-control study involving U.S. Veterans Affairs Healthcare System patients indicate that the Omicron KP.2-adapted vaccine was 56-68% effective in preventing various COVID-19 outcomes during the early 2024-2025 respiratory virus season. A second study of U.S. adults aged 18 and older who visited CVS MinuteClinics found that those who received the vaccine were 48% less likely to have COVID-19-related clinic visits.
Regulatory Updates
The company’s and Pfizer’s Omicron JN.1 and Omicron KP.2-adapted monovalent COVID-19 vaccines received multiple regulatory approvals and authorizations in more than 40 countries and regions in 2024.
In April 2024, the WHO and the European Medicines Agency, or EMA, followed in later months by other health authorities, provided guidance highlighting evidence that updated vaccines targeting Omicron JN.1 or JN.1 sublineages may contribute to maintaining protection against COVID-19 during the upcoming fall and winter seasons.
In June 2024, the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC, issued guidance recommending the manufacturing of a JN.1-adapted monovalent COVID-19 vaccine for the 2024/2025 fall and winter seasons. Also in June 2024, the FDA announced the KP.2 strain as the preferred JN.1-lineage for COVID-19 vaccines, if feasible.
Omicron JN.1-adapted monovalent COVID-19 vaccine
In 2024, the company and Pfizer received the following approvals for their Omicron JN.1-adapted monovalent COVID-19 vaccine:
June 2024: the Committee for Medicinal Products for Human Use, or CHMP, of the EMA recommended marketing authorization for the company’s and Pfizer’s Omicron JN.1-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. The adaptation was based on the recommendation from the WHO Technical Advisory Group on COVID-19 Vaccine Composition and the EMA’s Emergency Task Force, or ETF, to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024/2025 fall and winter vaccination campaign. In July 2024, the EC adopted an EC Decision in accordance with the CHMP’s recommendation.
July 2024: the respective EC Decision also covered that Comirnaty may be administered concomitantly with seasonal influenza vaccine in individuals 12 years of age and older and authorized a new presentation for the 30-mcg adapted vaccine, namely glass pre-filled syringe (refrigerated storage conditions).
July 2024: the UK’s Medicines and Healthcare products Regulatory Agency, or MHRA, approved the company’s and Pfizer’s Omicron JN.1-adapted vaccine. Omicron KP.2-adapted monovalent COVID-19 vaccine In 2024, the company and Pfizer received the following approvals for their Omicron KP.2-adapted monovalent COVID-19 vaccine:
June 2024: the company and Pfizer submitted a regulatory application to the FDA for an Omicron JN.1-adapted monovalent vaccine and initiated a rolling supplemental Biologics Licensing Application, or sBLA, for an Omicron KP.2-adapted monovalent vaccine. In August 2024, the FDA approved the sBLA for the company’s Omicron KP.2-adapted 2024-2025 formula COVID-19 vaccine for individuals 12 years of age and older and granted EUA for individuals six months through 11 years of age.
September 2024: the CHMP of the EMA also recommended marketing authorization for the company’s and Pfizer’s Omicron KP.2-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 in individuals six months of age and older. The EC adopted an EC Decision in accordance with the CHMP recommendation one week later.
October 2024: the FDA approved the sBLA to include safety and immunogenicity data from a study in which individuals 18 through 64 years of age received Comirnaty concomitantly with a seasonal influenza vaccine.
October 2024: the UK’s MHRA approved the company’s Omicron KP.2-adapted vaccine. The company and Pfizer intend to continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas as the data support and as regulatory agencies recommend.
Pipeline of Product Candidates
The company is advancing a broad portfolio of product candidates derived from multiple platforms and is focused on immunotherapies for the potential treatment of cancer and mRNA vaccines to potentially prevent or treat infectious diseases.
Oncology Programs
mRNA Product Class in Oncology
FixVac: FixVac is the company’s fully owned, systemic, off-the-shelf mRNA-based cancer immunotherapy approach, from which it is developing several potential first-in-class product candidates. FixVac product candidates contain the company’s optimized uridine-RNA delivered in its proprietary RNA-lipoplex nanoparticles, or RNA-LPX, formulation for intravenous administration. The Proprietary RNA-LPX protects the RNA from degradation by RNAse and is designed for RNA delivery into antigen-presenting cells in lymphoid organs body-wide. FixVac candidates are designed to target shared antigens that have been identified to be frequently expressed across patients with a specific cancer type. These product candidates are designed to trigger both innate and adaptive immune responses.
BNT111 in Advanced Melanoma
BNT111 is designed to elicit an immune response to four antigens (NY-ESO-1, MAGE-A3, tyrosinase, TPTE) that have each been found to be associated with cutaneous melanoma.
Ongoing Phase 2 Trial
An open-label, randomized, multi-site, Phase 2 clinical trial (BNT111-01; NCT04526899) is being conducted in collaboration with Regeneron Pharmaceuticals Inc., or Regeneron, to evaluate BNT111 in combination with cemiplimab versus both agents as monotherapy in 184 patients with anti-PD-1-/anti-PD-L1 refractory/relapsed, unresectable Stage III or IV melanoma. The primary endpoint is objective response rate, or ORR. Secondary endpoints include duration of response, or DOR, disease control rate, or DCR, time to response, or TTR, progression-free survival, or PFS, overall survival, or OS, and safety.
In July 2024, the company announced that the trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in ORR in patients treated with BNT111 in combination with cemiplimab, as compared to a historical control in this indication and setting. The ORR in the cemiplimab monotherapy arm was in line with the historical control of anti-PD-(L)1 or anti-CTLA-4 treatments in this patient group. The treatment was generally well tolerated, and the safety profile of BNT111 in combination with cemiplimab was consistent with previous clinical trials assessing BNT111 in combination with anti-PD-(L)1-containing treatments. The Phase 2 trial will continue as planned to further assess the secondary endpoints that were not mature at the time of the primary analysis. The company plans to present these data at an upcoming medical conference in 2025.
Phase 1 Trial
A multi-center, open-label, first-in-human, Phase 1, dose escalation clinical trial (Lipo-MERIT; NCT02410733) evaluating the safety and tolerability of BNT111 in patients with advanced melanoma was completed in 2023. This was the first clinical trial worldwide in which an mRNA-based cancer immunotherapy was administered intravenously for systemic treatment.
The trial started in 2015. Enrollment was completed in 2020 with 115 patients, and the last patient visit under the follow-up period took place in June 2023.
BNT112 for the Treatment of Prostate Cancer
BNT112 is designed to elicit an immune response to five antigens expressed in de novo and metastatic prostate cancer, including prostate-specific antigen, or PSA, a transmembrane protein that is expressed by virtually all prostate cancers, prostatic acid phosphatase, or PAP, and three additional tumor-associated antigens.
Phase 1/2a Clinical Trial
PRO-MERIT is a first-in-human Phase 1/2a, open-label dose titration and expansion clinical trial (PRO-MERIT; NCT04382898) to evaluate the safety, immunogenicity, and preliminary efficacy of BNT112 monotherapy and in combination with cemiplimab in patients with metastatic castration-resistant prostate cancer, or mCRPC, and high-risk localized prostate cancer who are eligible for treatment with androgen deprivation therapy followed by radical prostatectomy. The trial has been discontinued, and the follow-up period ended in January 2024.
BNT113 for the Treatment of Head and Neck Squamous Cell Carcinoma, or HNSCC, which is positive for Human Papilloma Virus 16, or HPV16+
BNT113 contains two different RNAs encoding the two HPV16 oncoproteins E6 and E7, which are exclusively expressed in pre-malignant and malignant tissue. The global incidence of HPV-associated cancers has been increasing, particularly HPV16+ HNSCC in younger populations. Most patients with HPV16+ HNSCC are diagnosed at more advanced clinical stages.
Ongoing BNT113 Phase 2 Trial
A global, randomized Phase 2 clinical trial (AHEAD-MERIT; NCT04534205) evaluating BNT113 in combination with pembrolizumab (Merck & Co., Inc.’s KEYTRUDA) versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 is ongoing. Part A is a non-randomized run-in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. Part B is the randomized portion of the trial designed to generate efficacy and safety data. The trial plans to enroll a total of 350 patients.
In September 2024, an exploratory analysis of antitumor activity (15 patients) and immunogenicity from the safety run-in of AHEAD-MERIT was presented at the 2024 Congress of the European Society of Medical Oncology, or ESMO. The ORR was found to be 40.0% as assessed by blinded independent central review, or BICR, and 33.3% as assessed by the investigator, and a medium PFS, or mPFS, of 3.9 months as per BICR and 6.0 months as per investigator. BNT113 was observed to induce de novo T-cell responses against HPV16 E6 and E7 oncoproteins. The combination of BNT113 and pembrolizumab was well tolerated. Treatment emergent adverse events, or TEAEs, were mostly Grade 1 and 2. In summary, the safety run-in cohort of the ongoing AHEAD-MERIT trial supported the tolerability of BNT113, and clinical activity in combination with pembrolizumab was observed.
Phase 1/2 Trial (Investigator-Initiated and Sponsored)
BNT113 was investigated by the University Hospital Southampton National Health Service, or NHS, Foundation Trust in an investigator-sponsored, open-label, Phase 1/2 dose escalation basket clinical trial (HARE-40; NCT03418480) with two different arms in 29 patients with HPV16+ head and neck and other cancers in the post-adjuvant and metastatic setting. The trial has been terminated, and the patient follow-up period ended in July 2023.
In September 2024, results were presented at ESMO. BNT113 was shown to induce immune responses in patients in the adjuvant and end-stage clinical settings and to be overall well tolerated with a manageable safety profile.
BNT116 for the Treatment of Non-small Cell Lung Cancer, or NSCLC
BNT116 consists of six different NSCLC-associated tumor-associated antigens for the induction of polyepitopic anti-tumor CD8+ and CD4+ T cell responses. BNT116 is being evaluated in two clinical trials as monotherapy and in combination with other immunotherapies and chemotherapies in patients with advanced or metastasized NSCLC.
Ongoing Phase 2 Trial in 1L NSCLC
A randomized, controlled Phase 2 clinical trial (EMPOWERVAX Lung-1; NCT05557591) is ongoing in collaboration with Regeneron to evaluate BNT116 in combination with cemiplimab versus cemiplimab alone as first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 in = 50% of their tumor cells. The primary objective of the Phase 2 trial is to assess safety and tolerability, as well as ORR and tumor burden reduction.
Ongoing Phase 1 Trial in NSCLCA
A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted to evaluate the safety, tolerability, and preliminary efficacy of BNT116 as monotherapy and in several combinations, including cemiplimab and chemotherapy regimens, in locally advanced or unresectable or metastatic NSCLC. A cohort examining the combination of BNT116 with a cytotoxic T-lymphocyte-associated, or CTLA-4, antibody in patients who have received prior PD-1 inhibitor therapy and platinum-based chemotherapy was recently added.
In April 2024, data from cohort 3 of the Phase 1 trial were presented at the American Association for Cancer Research, or AACR, Annual Meeting. Patients were treated with BNT116 in combination with docetaxel after progression on a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy. Preliminary data of BNT116 in combination with docetaxel showed encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Combination therapy with BNT116 and docetaxel was observed to have an ORR of 30% and a DCR of 85%.
In November 2024, data from cohort 2 of the Phase 1 trial were presented at the Society for Immunotherapy of Cancer, or SITC, Annual Meeting. Patients were treated with BNT116 in combination with cemiplimab. Safety and clinical activity of BNT116+cemiplimab in NSCLC with PD-L1=50% progressing after at least stable disease, or SD, on PD-1 inhibitor-based first-line treatment was reported. Preliminary data of BNT116 in combination with cemiplimab showed a manageable safety profile, an encouraging DCR of 80%, and a median PFS of 5.5 months in patients previously progressing on PD-1 inhibition.
Autogene Cevumeran (BNT122/RO7198457), or iNeST
Autogene cevumeran is an investigational individualized cancer immunotherapy based on specific neoantigens that are present on a patient’s tumor. Similar to the company’s FixVac programs, its iNeST approach is also based on pharmacologically optimized uridine mRNA, or uRNA, delivered in its proprietary RNA-LPX formulation. The RNA-LPX is designed to deliver RNA to dendritic cells, or DCs, the antigen-presenting cells in the lymphoid organs that are crucial for the initiation of adaptive immune responses, and protects RNA from degradation by RNAse. iNeST candidates are informed by the mutation profile of a patient’s individual cancer and manufactured on-demand. The RNA encodes a unique composition of neoantigens selected on a patient-by-patient basis and results in the generation of neoantigen-specific CD4+ and CD8+ T cell responses against the respective neoantigens. The aim of this approach is to generate and amplify anti-tumor immune responses and thus broaden the spectrum of tumor targets that can be recognized by the immune system, which is a prerequisite for clinical activity.
Ongoing Phase 2 Clinical Trial in Adjuvant High-risk Muscle-invasive Urothelial Carcinoma, or MIUC
A randomized, double-blind, multi-site Phase 2 clinical trial (IMCODE-004; NCT06534983) evaluating autogene cevumeran as an adjuvant treatment with nivolumab in patients with high-risk MIUC is ongoing.
In December 2024, the first patient was treated. The trial is expected to enroll approximately 360 patients to evaluate the efficacy of autogene cevumeran in combination with nivolumab compared to nivolumab alone. The primary endpoint for the study is investigator-assessed disease-free survival, or DFS. Secondary objectives include OS and safety.
Ongoing Phase 2 Clinical Trial in Adjuvant Colorectal Cancer, or CRC
A randomized, multi-site, open-label Phase 2 clinical trial (BNT122-01; NCT04486378) evaluating autogene cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III CRC is ongoing. The trial is expected to enroll about 200 patients to evaluate the efficacy of autogene cevumeran compared to watchful waiting after surgery and chemotherapy, the current standard of care for these high-risk patients. The primary endpoint for the study is DFS. Secondary objectives include OS and safety. The trial is currently enrolling in the United States, Germany, Spain, Belgium, Sweden, and the UK. The company plans to disclose the first data from the ongoing Phase 2 clinical trial in Stage II (high-risk)/Stage III ctDNA+ adjuvant CRC in late 2025 or early 2026.
In June 2024, at the Annual Meeting of the American Society of Clinical Oncology, or ASCO, preliminary epidemiologic data were presented, including post-operative ctDNA prevalence and prognostic value in disease-free survival, from an observational study (NCT04813627) in patients with resected high-risk stage II/III CRC. This observational study provides supportive epidemiological and prognostic data for the ongoing interventional Phase 2 clinical trial (NCT04486378).
Also in June 2024, at the ESMO Gastrointestinal, or ESMO GI, Cancers Congress, immunogenicity data of the biomarker cohort of the ongoing Phase 2 (NCT04486378) that enrolled patients irrespective of post-surgical ctDNA status were presented. The data suggest that autogene cevumeran is highly immunogenic and induces de novo polyepitopic, ex vivo detectable T-cell responses in all evaluable patients with resected Stage II/III CRC after completion of adjuvant chemotherapy. Among patients included in the immunogenicity analysis, 100% (12/12) were disease-free at data cut-off.
Ongoing Phase 2 Clinical Trial in Adjuvant Pancreatic Ductal Adenocarcinoma, or PDAC
A randomized Phase 2 clinical trial (IMCODE003; NCT05968326) evaluating the safety and efficacy of autogene cevumeran in combination with atezolizumab followed by standard-of-care chemotherapy (mFOLFIRINOX) in patients with resected PDAC compared to chemotherapy alone is recruiting. The Phase 2 study is expected to enroll 260 patients with resected PDAC who have not received prior systemic anti-cancer treatment and showed no evidence of disease after surgery. The primary endpoint is DFS. Secondary endpoints include OS and safety.
In April 2024, at the AACR Annual Meeting, long-term follow-up data were presented from an investigator-initiated Phase 1 trial (NCT04161755) in patients with resected PDAC indicating that autogene cevumeran continues to show polyspecific T-cell responses up to three years after vaccination and that immunotherapy-specific response correlates with delayed tumor recurrence. At the third year, autogene cevumeran was observed to induce de novo neoantigen-specific, functional, and durable CD8 T cells at substantial magnitudes for multiple neoantigens. After a median follow-up of three years, eight patients with immunotherapy-induced T-cell responses continued to have longer median recurrence-free survival (not reached) compared with those who did not experience an immune response (13.4 months). The investigator-initiated, single-center Phase 1 trial evaluated the safety of autogene cevumeran in sequential combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard-of-care chemotherapy in 16 patients with resected PDAC. Data from the 1.5-year median follow-up had been published in Nature (Rojas, L.A. et al., 2023).
In February 2025, the longer-term follow-up of the investigator-initiated, single-center Phase 1 trial in PDAC has now also been published in Nature (Sethna, Z. et al., 2025).
Phase 2 Clinical Trial in First-line Advanced Melanoma
The IMCODE001 (NCT03815058) trial was the first randomized Phase 2 clinical trial with an iNeST-based candidate as part of the broader IMCODE study program. The trial was initiated in 2019 with the aim to investigate autogene cevumeran in combination with PD-L1 checkpoint blockade in the advanced treatment setting of unresectable or complex metastatic tumors. The trial evaluated the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone as a potential first-line treatment for patients with previously untreated advanced melanoma. The primary endpoint was progression-free survival (‘PFS’) and was events-based. Secondary endpoints included overall survival (‘OS’), overall response rate (‘ORR’), duration of response (‘DOR’), and safety.
In January 2025, the IMCODE001 trial was completed. While the initial data of the primary analysis support its data across the broader autogene cevumeran study program demonstrating that autogene cevumeran can induce and expand high-magnitude and long-lived de novo immune responses against the encoded neoantigens in this aggressive stage of melanoma, the trial did not meet its primary efficacy endpoint of statistically significant improvement of PFS in this advanced treatment setting. A numerical trend favoring the combination arm in overall survival was observed. The combination of autogene cevumeran with PD-L1 checkpoint blockade was well tolerated, and adverse events were consistent with the known safety profiles of the individual trial treatments, with no new safety signals observed. The analysis of the results of the IMCODE001 trial, including further exploratory endpoints and extensive biomarker correlations, is ongoing.
Ongoing Phase 1a/1b Clinical Trial Advanced/Metastatic Solid Tumors
An open-label Phase 1a monotherapy/1b in combination with atezolizumab clinical trial (NCT03289962) of autogene cevumeran in patients with locally advanced or metastatic solid tumors, including patients with melanoma, NSCLC, bladder cancer, CRC, triple-negative breast cancer, or TNBC, renal cancer, head and neck cancer, and sarcomas, as well as other solid tumors, is fully enrolled, and follow-up is ongoing.
In January 2025, a manuscript summarizing the results of the trial was published in Nature Medicine (Lopez, J. et al., 2025).
RiboMabs
The company’s RiboMab product candidate is an mRNA that encodes cancer cell-targeting antibodies. This fully owned product candidate is nucleoside-modified to minimize immunogenicity, and its improved mRNA backbone designs aim to maximize protein expression. The company’s RiboMab product candidate is formulated using liver-targeting lipid nanoparticles, or LNPs, for intravenous delivery. This RNA-LNP technology is designed to address the challenges of recombinantly expressed proteins, including limited serum half-life and manufacturing process challenges.
BNT142 for the Treatment of Solid Tumors
BNT142 encodes a T-cell engaging bispecific antibody targeting Claudin 6, or CLDN6. An open-label, multi-site Phase 1/2 clinical trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors that have exhausted available standard therapy is ongoing.
RiboCytokines
The company’s RiboCytokine product candidates are designed to address the limitations of recombinantly expressed cytokines, including limited serum half-life and production costs. BNT151 and BNT152+153 are nucleoside-modified mRNAs encoding human cytokines fused to human serum albumin. The modified mRNA is formulated with liver-targeting LNPs for intravenous delivery. BNT151 encodes an IL-2 variant, BNT152 encodes IL-7, and BNT153 encodes IL-2.
BNT151 for the Treatment of Solid Tumors
A first-in-human, open-label, multi-center Phase 1/2 clinical trial (NCT04455620) in multiple solid tumor indications has been discontinued after the completion of enrollment for the Part 1 monotherapy dose escalation, as previously communicated. The safety follow-up phase for enrolled patients has been completed, and the clinical data of the trial were reported to the appropriate regulatory bodies.
BNT152+BNT153 for the Treatment of Solid Tumors
An open-label, multi-site, first-in-human Phase 1 clinical trial (NCT04710043) in multiple solid tumor indications is ongoing to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of a combination of BNT152 and BNT153. The clinical trial consists of two parts: Part 1, the separate monotherapy dose escalation of BNT152 and BNT153, was completed in May 2023, as a result of which a maximum tolerated dose, or MTD, was defined for each product. Part 2 is currently investigating the combination treatment of BNT152 and BNT153.
Oncology Cell Therapy Product Candidates
CAR-T-cell therapy - CAR-T
BNT211 for the Treatment of CLDN6+ Solid Tumors
BNT211 consists of two investigational medicinal products: the company’s first CAR-T-cell product candidate, which targets CLDN6-positive solid tumors, in combination with an mRNA named CARVac (CLDN6 RNA-LPX) encoding CLDN6. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity for the tumor-specific carcino-embryonic antigen CLDN6. CARVac is intended to support in vivo expansion of transferred CAR-T cells to increase their persistence and efficacy. As with FixVac and iNeST, CARVac is also based on a pharmacologically optimized backbone equipped uRNA delivered in its proprietary RNA-LPX formulation. BNT211 has been granted Priority Medicines, or PRIME, designation by the EMA for the third- or later-line treatment of testicular germ cell tumors, and Regenerative Medicine Advanced Therapy, or RMAT, designation by the FDA.
Ongoing Phase 1 Clinical Trial
A first-in-human, open-label, multi-site Phase 1 dose escalation and dose expansion basket trial (NCT04503278) is being conducted to evaluate CLDN6 CAR-T cells as monotherapy or in combination with CARVac in patients with CLDN6-positive relapsed or refractory solid tumors, including ovarian cancers and testicular germ cell tumors. The primary outcome measure of the trial is safety, with secondary efficacy outcome measures to include ORR, DCR, and DOR.
In June 2024, the company presented an analysis of real-world data that investigated the OS, treatment patterns, and prognostic variables of patients with testicular germ cell tumors receiving palliative chemotherapy at the ASCO Annual Meeting. This analysis will inform the design of the company’s planned pivotal clinical trial to evaluate BNT211 in patients with germ cell tumors.
In September 2024, data from the ongoing trial were presented at the ESMO Congress, which showed encouraging signs of antitumor activity across indications. Among patients who received dose levels of 1 * 10^8 CAR T cells or above with or without CARVac, ORR was observed to be 41.7% for patients with testicular cancer and 58.3% for those with ovarian cancer. CARVac was shown to improve CAR-T persistence in some patients. The data also suggest that the safety profile of CLDN6 CAR T cells with and without CARVac is consistent with the previously published effects of CAR-T therapies and that repeated CARVac administration does not significantly increase toxicity.
In January 2025, the FDA granted RMAT designation for BNT211. The RMAT designation is designed to expedite the development and review process for promising pipeline products, including cell therapies.
A pivotal Phase 2 trial in patients with testicular germ cell tumors is planned to start in 2025 based on encouraging activity in this patient group observed in the Phase 1 trial.
Neoantigen-Targeting T Cells
The company’s neoantigen-targeting T-cell stimulation platform can be utilized to develop product candidates across several neoantigen-targeting non-engineered and engineered T-cell therapies. Autologous, neoantigen-specific T cells are primed, activated, and expanded ex vivo utilizing a proprietary antigen-specific T-cell induction protocol, Neo-Stim, to target either a personal set of neoantigens for each patient or a set of selected shared neoantigens. The company’s lead product candidate under this platform is its individualized neoantigen-targeting T-cell therapy, BNT221.
BNT221 for the Treatment of Cancer
BNT221 is the company’s autologous, fully personalized, polyspecific T-cell therapy directed against selected sets of individual neoantigens. BNT221 is generated through a proprietary stimulation process (Neo-Stim) and allows for the induction of T cells from the naïve compartment, as well as expansion of pre-existing memory T cells. Other product characteristics are cells with high specificity profiles towards the mutant epitope; cells exhibiting multiple effector functions; a product that contains both central and effector memory T cells; and cells that have a cytotoxic response towards endogenously processed and presented antigens, as well as recognition of an autologous tumor. The neoantigens are selected using its proprietary Recon bioinformatics engine.
Ongoing Phase 1 Clinical Trial
A first-in-human Phase 1 dose escalation clinical trial (NCT04625205) evaluating BNT221 in patients with checkpoint inhibitor unresponsive or refractory metastatic melanoma is ongoing. The first portion of the trial consists of a monotherapy dose escalation of BNT221, for which recruitment and treatment of patients is complete. Currently, BNT221 is being dosed in combination with anti-PD-1 therapy after first-line treatment. Additional enrollment has been stopped for non-safety-related reasons, with health authorities notified. Major objectives of this study include evaluation of the safety and feasibility of administering BNT221, as well as evaluations of immunogenicity and preliminary efficacy.
In January 2025, a manuscript summarizing the results of the monotherapy portion of the trial was published in Nature Medicine (Borgers, J. et al., 2025).
Protein-based Therapeutic Product Candidates in Oncology
Next-Generation Immune Checkpoint Modulators
The company and Genmab are developing antibodies that are designed to function as tumor-targeted and dual immunomodulators, applying Genmab's proprietary technologies in combination with its joint target identification and product concept expertise. In addition, the company and Genmab are developing antibodies that are designed to enhance pre-existing immunity. The company and Genmab have three product candidates currently in clinical development as part of a 50:50 collaboration in which development costs and future profits are shared: BNT312/GEN1042 (DuoBody CD40x4-1BB), BNT314/GEN1059 (DuoBody-EpCAMx4-1BB), and BNT315/GEN1055 (HexaBody-OX40).
The company and OncoC4 have an ongoing strategic collaboration, which includes joint development of BNT316/ONC-392 (Gotistobart), an anti-CTLA-4 antibody, in a range of solid tumor indications, with the parties equally sharing development costs for such joint development studies. BioNTech holds the exclusive worldwide commercialization rights for this product candidate.
In February 2025, the company announced the completion of its acquisition of Biotheus. With the acquisition, it obtained full global rights to the bispecific antibody clinical asset BNT327, a PD-L1 x VEGF-A bispecific antibody, and Biotheus' pipeline candidates. This follows an initial exclusive global license and collaboration agreement with Biotheus in 2023 to develop, manufacture, and commercialize BNT327 globally outside of Greater China.
BNT311/GEN1046 (acasunlimab) a PD-L1x4-1BB Bispecific Antibody for the Treatment of Solid Tumors
BNT311/GEN1046 (acasunlimab) is an investigational, potential first-in-class bispecific antibody combining PD-L1 checkpoint inhibition with 4-1BB stimulation. BNT311/GEN1046 (acasunlimab) is being developed for the treatment of solid tumors using Genmab's proprietary DuoBody technology platform. BNT311/GEN1046 (acasunlimab) is currently being evaluated in multiple clinical trials.
In August 2024, the company announced that while the emerging clinical profile of BNT311/GEN1046 (acasunlimab) was encouraging, for reasons relating to portfolio strategy, it opted not to participate in the further development of the program, including an ongoing Phase 3 trial. In the event that the program is commercialized, the company will retain a tiered single-digit royalty on any potential sales. The company and Genmab will continue their collaboration on other programs under the existing agreements.
BNT312/GEN1042, a CD40x4-1BB Bispecific Antibody for the Treatment of Solid Tumors
BNT312/GEN1042 is a jointly owned, novel, agonistic, bispecific antibody that combines targeting and conditional activation of the costimulatory molecules CD40 and 4-1BB on immune cells. BNT312/GEN1042 is being developed for the treatment of solid cancers using Genmab's proprietary DuoBody technology platform, and the company’s CD40 and 4-1BB antibodies. The company and Genmab are currently evaluating BNT312/GEN1042 in several clinical trials.
Ongoing Clinical Trials
A Phase 1/2 dose-escalation clinical trial (NCT04083599) with expansion cohorts evaluating safety and anti-tumor activity of BNT312/GEN1042 as monotherapy and in combination therapies in patients with solid tumors is ongoing. The company and Genmab plan to determine next steps for this program in 2025.
An open-label Phase 1/2 clinical trial (NCT05491317) evaluating the safety and clinical activity of BNT312/GEN1042 in combination with radiotherapy with or without pembrolizumab in patients with metastatic solid tumors is ongoing.
A Phase 1 clinical trial (NCT06057038) in Japan evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BNT312/GEN1042 monotherapy and in combination with pembrolizumab with or without chemotherapy in patients with multiple solid tumors is ongoing.
BNT313/GEN1053, an Agonistic HexaBody-CD27 Antibody for the Treatment of Malignant Solid Tumors
BNT313/GEN1053 is a novel CD27 antibody with an immunoglobulin G, or IgG, Fc domain engineered to induce clustering of CD27 on the plasma membrane of T cells with the aim of enhancing T-cell activation, proliferation, and differentiation without depleting T cells. In preclinical studies, BNT313/GEN1053 increases T-cell activation, proliferation, cytokine secretion, and cytotoxic activity.
Phase 1/2 Clinical Trial
A Phase 1/2 clinical trial (NCT05435339) evaluating the safety, tolerability, and preliminary efficacy of CD27-targeting antibody BNT313/GEN1053 on solid tumors as monotherapy has been discontinued due to the strategic evaluation of BNT313/GEN1053 within the context of BioNTech's and Genmab's portfolios.
BNT314/GEN1059, an EpCAMx4-1BB Bispecific Antibody for the Treatment of Advanced or Metastatic Solid Tumors
BNT314/GEN1059 is a potential first-in-class bispecific antibody product candidate designed to boost antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity.
A BioNTech-sponsored first-in-human Phase 1/2 clinical trial (NCT06150183) is being conducted to investigate the safety and preliminary antitumor activity of BNT314/GEN1059 in patients with advanced or metastatic solid tumors.
A Trial-in-Progress poster from this trial was presented at the 2024 ESMO Congress.
BNT315/GEN1055, a HexaBody-OX40 Antibody for the Treatment of Advanced Solid Tumors
BNT315/GEN1055 is an OX40 agonist antibody designed to induce OX40 clustering independently of Fc-gamma receptor-, or FcyR-mediated crosslinking to enhance antitumor T-cell responses.
A first-in-human Phase 1/2 clinical trial (NCT06391775) is being conducted to investigate the safety and preliminary antitumor activity of BNT315/GEN1055 in patients with advanced or metastatic solid tumors.
BNT322/GEN1056, an Antibody for the Treatment of Solid Tumors
BNT322/GEN1056 is an antibody product candidate co-developed with Genmab for the treatment of solid tumors and for potential use in combination with other products. The development program for BNT322/GEN1056 has been discontinued due to strategic evaluation of the development program within the context of BioNTech's and Genmab's portfolios.
A first-in-human Phase 1 clinical trial (NCT05586321) of BNT322/GEN1056 in patients with advanced solid tumors is ongoing.
BNT317, an Antibody for the Treatment of Advanced Solid Tumors
BNT317 is a product candidate the company is developing for the treatment of solid tumors. A first-in-human, open-label, dose escalation Phase 1 clinical trial (NCT06750185) was initiated in January 2025 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
BNT327, a Bispecific Antibody Candidate Targeting PD-L1 and VEGF
BNT327 is an anti-VEGF-A antibody candidate fused to a humanized anti-PD-L1 VHH, previously being developed in collaboration with Biotheus. In February 2025, the company announced the completion of its acquisition of Biotheus. With the acquisition, it obtained full global rights to the late-stage clinical asset BNT327.
BNT327 is currently being evaluated in multiple Phase 2 and Phase 3 global and China-only clinical trials to assess the efficacy and safety of the candidate as monotherapy or in combination with chemotherapy in various indications. BNT327 is also being evaluated in combination with BNT325/DB-1305, a next-generation ADC candidate, in a Phase 1/2 clinical trial. The company also plans to evaluate BNT327 in combination with its other clinical-stage ADCs, BNT323/DB-1303, BNT324/DB-1311, and BNT326/YL202.
Ongoing Phase 3 Clinical Trial in Extensive-Stage Small Cell Lung Cancer, or ES-SCLC
In December 2024, BioNTech initiated a global, randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327 plus chemotherapy compared to atezolizumab plus chemotherapy in first-line ES-SCLC.
Ongoing Phase 3 Clinical Trial in Locally Advanced/Metastatic TNBC
A Phase 3 clinical trial (NCT06419621) evaluating BNT327 in combination with chemotherapy compared to chemotherapy as a first-line treatment for patients with locally advanced/metastatic TNBC is ongoing in China.
Ongoing Phase 3 Clinical Trial in Second-Line Small-Cell Lung Cancer, or SCLC
A Phase 3 clinical trial (NCT06616532) evaluating BNT327 in combination with chemotherapy compared to investigator's choice chemotherapy as a second-line treatment for patients with SCLC is ongoing in China.
Ongoing Phase 2 Clinical Trial in ES-SCLC
In September 2024, the first patient was dosed in a multi-site, open-label Phase 2 clinical trial (NCT06449209) to evaluate BNT327 in combination with chemotherapy in patients with untreated ES-SCLC and in patients with SCLC that progressed after first- or second-line treatment. The study is recruiting in the United States, Türkiye, Australia, South Korea, and the UK.
Ongoing Phase 2 Clinical Trial in Locally Advanced/Metastatic TNBC
In October 2024, the first patient was dosed in a multi-site, open-label Phase 2 clinical trial (NCT06449222) to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapy in the first and second-line treatment of patients with locally advanced/metastatic TNBC. The study is recruiting in the United States, Australia, Türkiye, and the UK. A Phase 3 clinical trial in first-line TNBC is expected to start in 2025.
Ongoing Phase 2/3 Clinical Trial in First-Line NSCLC
In December 2024, BioNTech initiated a global, randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327 plus chemotherapy compared to pembrolizumab and chemotherapy in first-line NSCLC.
Ongoing Phase 2 Clinical Trial in First-Line ES-SCLC
A Phase 2 clinical trial (NCT05844150) evaluating BNT327 in combination with chemotherapy as a first-line treatment for patients with ES-SCLC is ongoing in China.
Ongoing Phase 2 Clinical Trial in Second-Line ES-SCLC
A Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line treatment for patients with SCLC is ongoing in China.
Ongoing Phase 2 Clinical Trial in Neuroendocrine Neoplasm, or NEN
A Phase 2 clinical trial (NCT05879055) evaluating BNT327 in combination with chemotherapy as a second-line treatment for patients with NEN is ongoing in China.
Ongoing Phase 2 Clinical Trial in Malignant Mesothelioma, or MPM
A Phase 2 clinical trial (NCT05918107) evaluating BNT327 in combination with chemotherapy as a first-line treatment for patients with MPM is ongoing in China.
Ongoing Phase 2 Clinical Trial in EGFR-mutant Non-Squamous NSCLC
A Phase 2 clinical trial (NCT05756972) evaluating BNT327 in combination with chemotherapy as a treatment for patients with EGFR-mutant NSCLC who have failed EGFR-tyrosine kinase inhibitor treatment is ongoing in China.
In September 2024, data from the trial were presented at the ASCO Annual Meeting. Data on 48 patients with advanced cervical cancer, or CC, showed an ORR of 42.2% (52.4% in patients with PD-L1-positive tumors), a DCR of 93.3%, and an mPFS of 8.3 months. Data on 39 patients with PROC showed an ORR of 20.6%, a DCR of 67.7%, and an mPFS of 5.5 months. TRAEs occurred in 95.4% of patients (83/87), with = Grade 3 TRAEs in 36.8% (32/87). 14.9% (13/87) of patients discontinued BNT327 and/or chemotherapy administration due to TRAEs, plus one case of TRAE-related death.
In September 2024, at the ESMO Congress, data from the trial were presented. 64 patients were observed to have an ORR of 60.9%, a cORR of 57.8%, and DCR of 95.3%. In the 28 patients with PD-L1 tumor proportion score, or TPS, <1%, the ORR was observed to be 46.4%, and DCR was observed to be 92.9%. In the 23 patients with TPS 1-49%, the ORR was observed to be 60.9%, and DCR was observed to be 100%. Among the 13 patients with TPS =50%, the ORR was observed to be 92.3%, and DCR was observed to be 92.3%. Any-grade TRAEs occurred in 98.4% of patients, and Grade = 3 TRAEs occurred in 60.9% of patients. Nine patients discontinued BNT327 and/or chemotherapy administration due to TRAEs, plus one case of TRAE-related death.
Ongoing Phase 2 Clinical Trial in Hepatocellular Carcinoma, or HCC
A Phase 2 clinical trial (NCT05864105) evaluating BNT327 in combination with chemotherapy as a first-line treatment for unresectable HCC is ongoing in China.
Ongoing Phase 1/2 Clinical Trial in Advanced Solid Tumors
A Phase 1/2 clinical trial (NCT05918445) evaluating BNT327 as a monotherapy in patients with advanced solid tumors is ongoing in China.
In June 2024, data from the trial were presented at the ASCO Annual Meeting. Data on 48 patients with advanced cervical cancer, or CC, showed an ORR of 42.2% (52.4% in patients with PD-L1-positive tumors), a DCR of 93.3%, and an mPFS of 8.3 months. Data on 39 patients with PROC showed an ORR of 20.6%, a DCR of 67.7%, and an mPFS of 5.5 months. TRAEs occurred in 95.4% of patients (83/87), with = Grade 3 TRAEs in 36.8% (32/87). 14.9% (13/87) of patients discontinued BNT327 treatment due to TRAEs, plus one case of TRAE-related death.
In September 2024, at the ESMO Congress, data from the trial were presented. 28 patients with clear cell RCC, or ccRCC, who progressed after a combination of anti-PD-(L)1 and VEGF-TKI therapy or VEGF-TKI monotherapy, were observed to have an ORR of 25%, a DCR of 82.1%, a mPFS of 10.9 months, and a mDOR of 19.6 months. The 22 patients with previously untreated non-clear cell RCC, or nccRCC, were observed to have an ORR of 36.4%, a DCR of 90.9%, and a mPFS of 15.1 months. Any-grade and Grade 23 TRAEs of the combination regimen occurred in 100% and 41.5% of patients, respectively. TRAEs leading to treatment discontinuation occurred in 1.9% of patients. In summary, BNT327 monotherapy was observed to have encouraging anti-tumor activity and a manageable safety profile in patients with previously untreated advanced nccRCC or previously treated advanced ccRCC.
Ongoing Phase 1/2 Clinical Trial in Locally Advanced/Metastatic TNBC
A Phase 1b/2 clinical trial (NCT05918133) evaluating BNT327 in combination with chemotherapy in patients with locally advanced or metastatic TNBC without previous systematic treatment is ongoing in China.
In September 2024, at the ESMO Congress, data from the trial were presented. 42 patients were observed to have an ORR of 78.6%, a confirmed ORR, or CORR, of 73.8%, with a DCR of 95.2%, an mPFS of 13.5 months, and a median duration of response, or mDOR, of 11.7 months. Among the 42 patients treated, 38 patients had available PD-L1 expression results assessed by means of a PD-L1 immunohistochemistry, or IHC, E1L3N assay. CORR was observed to be 76.9% in 13 patients with PD-L1 combined positive scores, or CPS, <1, 56.3% in the 16 patients with PD-L1 1 <= CPS < 10, and 100% in the nine patients with PD-L1 CPS=10. Any-grade and Grade 23 TRAEs of the combination regimen occurred in 100% and 57.1% of patients, respectively. The most common TRAEs included neutropenia, leukocytopenia, anemia, proteinuria, and alopecia. In summary, first-line treatment of locally advanced/metastatic TNBC with BNT327 in combination with nab-paclitaxel was observed to be associated with clinically meaningful antitumor activity regardless of PD-L1 status and manageable toxicity with no new safety signals observed beyond those typically described for anti-PD-(L)1 therapies, anti-VEGF therapies, and chemotherapy.
In December 2024, at the San Antonio Breast Cancer Symposium, or SABCS, updated data were presented from the trial. In 42 patients with locally advanced or metastatic TNBC, first-line therapy with BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity regardless of PD-L1 status, together with a manageable safety profile. The confirmed ORR was 73.8% with a DCR of 95.2%. The median TTR, or mTTR, was 1.9 months, and the mDOR was 11.7 months. The matured mPFS was 13.5 months for the intention-to-treat, or ITT, population. The median OS, or mOS, was not reached, while the matured 12-month OS rate was 80.8%, the matured 15-month OS rate was 78.1%, and the nearly matured 18-month OS rate was 69.7%.
Ongoing Phase 1/2 Clinical Trial in First Line HCC
A Phase 1/2 clinical trial (NCT06584071) evaluating BNT327 in combination with PM1009 in patients with locally advanced or metastatic HCC is ongoing in China. The study is divided into two parts. The first part is a Phase 1b, single-arm study. The second part is a Phase II randomized controlled study.
Ongoing BNT325/DB-1305 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A multi-center, non-randomized, open-label, multiple-dose, first-in-human Phase 1/2a clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. As part of this clinical trial, BNT325/DB-1305 is being studied in combination with BNT327 in various solid tumor indications. The company plans to present first clinical data from the ongoing global Phase 1/2 expansion cohorts evaluating BNT327 plus BNT325/DB-1305 in multiple solid tumors in 2025.
BNT316/ONC-392 (gotistobart), an Anti-CTLA-4 Monoclonal Antibody Candidate in Development in Collaboration with OncoC4
BNT316/ONC-392 (gotistobart) is an anti-cytotoxic T-lymphocyte-associated protein 4, or CTLA-4, monoclonal antibody candidate being developed in collaboration with OncoC4. CTLA-4 is a molecule that inhibits T-cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells. Blocking CTLA-4 preserves T-cell activity and enhances anti-tumor activity. BNT316/ONC-392 (gotistobart) is designed to offer a differentiated safety profile that may allow for higher dosing and longer duration of treatment both as monotherapy and in combination with other therapies. The program received Fast Track Designation from the FDA in 2022.
Ongoing Phase 3 Clinical Trial in Metastatic, Immunotherapy-resistant NSCLC
In December 2024, the company was informed by its partner OncoC4 that the FDA had lifted the partial clinical hold on PRESERVE-003 (NCT05671510), a two-stage, open-label, randomized Phase 3 trial evaluating the efficacy and safety of BNT316/ONC-392 (gotistobart) as monotherapy in patients with metastatic NSCLC that progressed under previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. Based on the available trial data and following an alignment with the FDA, the companies will continue enrollment solely of patients with squamous NSCLC.
The company had previously announced the partial clinical hold on the study in October 2024, following OncoC4's communication to the FDA after an assessment of the trial data by the independent Data Monitoring Committee, which identified a possible variance in results between the squamous and non-squamous NSCLC patient populations. The partial clinical hold only affected new patient enrollment and did not impact patients already enrolled in the trial. Trials evaluating BNT316/ONC-392 in other indications also remained unaffected.
Ongoing Phase 2 Clinical Trial in Platinum-resistant Ovarian Cancer
A Phase 2 clinical trial (PRESERVE-004; NCT05446298) is being conducted to evaluate BNT316/ONC-392 (gotistobart) therapy in combination with pembrolizumab in patients with PROC. The clinical trial is designed to evaluate multiple doses of BNT316/ONC-392 (gotistobart) in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy. The primary endpoints are ORR and safety. Secondary endpoints include DOR, DCR, PFS, and OS.
In September 2024, preliminary data from the ongoing trial were presented at the ESMO Congress. The data were also presented at the International Gynecologic Cancer Society Annual Global Meeting in October 2024. 33 and 29 patients in 1 mg/kg and 2 mg/kg BNT316/ONC-392 (gotistobart) dose groups, respectively, were observed to have an unconfirmed ORR of 25% and 27.6%, respectively. Grade =3 TEAEs related to either drug were observed in 45.5% and 41.4% of patients in the 1 mg/kg and 2 mg/kg groups, respectively. In summary, these data suggest encouraging preliminary clinical activity and a manageable tolerability profile with no new safety signals detected.
Ongoing Phase 1/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer
A Phase 1/2 clinical trial (PRESERVE-006; NCT05682443) is being conducted to evaluate the safety and efficacy of BNT316/ONC-392 (gotistobart) in combination with lutetium Lu-177 vipivotide tetraxetan in patients with mCRPC who have disease progressed on androgen receptor pathway inhibition. The trial is expected to enroll approximately 144 patients at clinical trial sites in the United States. The primary endpoint is PFS.
Ongoing Phase 1/2 Clinical Trial in Advanced or Metastatic Solid Tumors
A first-in-human Phase 1/2 open-label dose escalation clinical trial (NCT04140526) evaluating BNT316/ONC-392 (gotistobart) as monotherapy and in combination with pembrolizumab in patients with advanced or metastatic solid tumors is ongoing.
Targeted Cancer Antibodies
BNT321 for the Treatment of Pancreatic Cancer
BNT321 is a high-affinity, fully human IgG1 monoclonal antibody targeting sialyl Lewis A, or sLea, an epitope on CA19-9, which is expressed in pancreatic and other gastrointestinal cancers. sLea plays a role in tumor adhesion and metastasis formation and is a marker of an aggressive cancer phenotype.
In January 2025, clinical trials involving BNT321 were discontinued.
Phase 1 Clinical Trial
A Phase 1 trial (NCT02672917) evaluated BNT321 monotherapy and in combination with mFOLFIRINOX in patients with advanced PDAC and other CA19-9+ tumors.
Data from the trial were presented at the ASCO Gastrointestinal Cancer Symposium 2024. Preclinically, BNT321 binding was observed to be highly specific and restricted to cancer tissues with sLea expression. The most frequent dose-limiting toxicities, or DLTs, for both monotherapy and for mFOLFIRINOX combination therapy were hepatic transaminase elevations. DLTs generally occurred in cycle 1 and did not preclude subsequent BNT321 administration at reduced doses. BNT321 in combination with mFOLFIRINOX was tolerable for multiple cycles. Clinical activity (27% PR, RECIST) was observed in patients receiving the combination as first or subsequent line therapy for advanced disease.
Phase 1/2 Clinical Trial
In April 2024, the first patient was dosed in a Phase 1/2 trial (NCT06069778) evaluating the safety, tolerability, and efficacy of BNT321 in combination with mFOLFIRINOX as an adjuvant therapy following curative resection in patients with PDAC.
Antibody Drug Conjugates
BNT323/DB-1303, an ADC in Development in Collaboration with DualityBio
BNT323/DB-1303 is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2, or HER2, a target that is over-expressed in a variety of cancers and contributes to the aggressive growth and spread of cancer cells. The program received Fast Track Designation from the FDA for endometrial cancer in 2023. In 2023, the FDA also granted Breakthrough Therapy designation for BNT323/DB-1303 for the potential treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.
Ongoing BNT323/DB-1303 Phase 3 Clinical Trial in Advanced or Metastatic Hormone Receptor-positive, or HR+ HER2-low Breast Cancer
An ongoing randomized, multi-site, open-label, pivotal Phase 3 clinical trial (DYNASTY-Breast02; NCT06018337) is recruiting to evaluate BNT323/DB-1303 versus the investigator's choice of chemotherapy in advanced or metastatic HR+, HER2-low breast cancer subjects whose disease has progressed on at least two lines of prior endocrine therapy or within six months of first-line endocrine therapy and cyclin-dependent 4/6, or CDK4/6, inhibitor and no prior chemotherapy. The first patient was dosed in January 2024. The trial aims to enroll approximately 532 patients. The primary endpoint is PFS. Secondary endpoints include OS, ORR, DCR, DOR, and safety, as well as patient-reported outcomes.
In September 2024, a Trial-in-Progress poster was presented at the ESMO Congress.
Topline data from the ongoing Phase 3 in patients with HR+ and HER2-low metastatic breast cancer who have progressed on hormone therapy and/or CDK4/6 inhibition is expected in 2026.
Ongoing BNT323/DB-1303 Phase 1/2 Clinical Trial in Advanced or Metastatic HER2-expressing Solid Tumors
BNT323/DB-1303 is being evaluated in an ongoing multi-center, non-randomized, open-label, multiple-dose, first-in-human Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors, including HER2-expressing breast cancer and endometrial cancer.
A potential registrational single-arm trial enrolling HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with endometrial carcinoma has completed enrollment.
A confirmatory Phase 3 trial (NCT06340568) to evaluate BNT323/DB-1303 in patients with advanced endometrial cancer is in planning.
BNT324/DB-1311, an ADC in Development in Collaboration with DualityBio
BNT324/DB-1311 is a topoisomerase-1 inhibitor-based ADC directed against B7H3. In June 2024, the company and DualityBio received Fast Track Designation for BNT324/DB-1311 from the FDA for the treatment of patients with advanced/unresectable, or metastatic CRPC, who have progressed on or after standard systemic regimens. In July 2024, the company and DualityBio received Orphan Drug Designation for BNT324/DB-1311 from the FDA for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma.
Ongoing BNT324/DB-1311 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A first-in-human, multi-center, open-label, dose escalation and dose-expansion Phase 1/2 clinical trial evaluating the safety and tolerability of BNT324/DB-1311 in patients with advanced solid tumors has been initiated, and the first patient was dosed in September 2023.
In December 2024, preliminary tumor-specific dose optimization data from the trial were presented at the ESMO Asia Congress, demonstrating encouraging efficacy and manageable safety across a range of advanced solid tumors.
BNT325/DB-1305, an ADC in Development in Collaboration with DualityBio
BNT325/DB-1305 is a topoisomerase-1 inhibitor-based ADC directed against TROP2. In January 2024, the company and DualityBio received Fast Track Designation for BNT325/DB-1305 from the FDA for the treatment of patients with PROC, fallopian tube, or primary peritoneal cancer in patients who have received one to three prior systemic treatment regimens.
Ongoing BNT325/DB-1305 Phase 1/2 Clinical Trial in Advanced Solid Tumors
A multi-center, non-randomized, open-label, multiple-dose, first-in-human Phase 1/2a clinical trial (NCT05438329) evaluating BNT325/DB-1305 in patients with advanced solid tumors is ongoing. As part of this clinical trial, BNT325/DB-1305 is being studied in combination with BNT327 in various solid tumor indications. The company plans to present first clinical data from the ongoing global Phase 1/2 expansion cohorts evaluating BNT327 plus BNT325/DB-1305 in multiple solid tumors in 2025.
BNT326/YL202, an ADC in Development in Collaboration with MediLink Therapeutics
BNT326/YL202 is a topoisomerase-1 inhibitor-based ADC directed against HER3. HER3 is a target that is overexpressed in various cancer types, such as NSCLC and breast cancer, and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment resistance.
Ongoing BNT326/YL202 Phase 1 Clinical Trial in NSCLC and Breast Cancer
A multi-site, international, open-label, first-in-human Phase 1 clinical trial (NCT05653752), sponsored by MediLink, is being conducted to evaluate BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic EGFR-mutated NSCLC or HR-positive and HER2-negative breast cancer. On August 15, 2024, the FDA lifted the partial clinical hold that was placed on this trial, initially announced on June 17, 2024. Trial recruitment has been reinitiated, and clinical development will focus on dose levels no higher than 3 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.
Oncology Small Molecule Immunomodulator Product Candidates
BNT411, a Small Molecule TLR7 Agonist for the Treatment of Solid Tumors, including SCLC
BNT411 is a TLR7 agonist that is designed to activate both the adaptive and innate immune system through the TLR7 pathway. This activity, and the release of cytokines and chemokines, are designed to result in the potent stimulation of antigen-specific CD8+ T cells, B cells, and innate immune cells, such as natural killer cells, or NK cells, and macrophages.
Phase 1/2 Trial
A Phase 1/2, first-in-human, open-label, dose escalation trial (NCT04101357) with expansion cohorts evaluating safety, pharmacokinetics, progression of disease, and preliminary efficacy of BNT411 as monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin, and etoposide in patients with chemotherapy-naïve ES-SCLC has been discontinued. Final data of the trial have been gathered and evaluated in a clinical study report. The final data were presented at the SITC Annual Meeting 2024 and are expected to be published in a scientific journal.
Infectious Disease Programs
Next-Generation COVID-19 Vaccine
BNT162b2 + BNT16264
In collaboration with Pfizer, the company aims to develop a vaccine candidate that enhances and broadens SARS-CoV-2 T-cell responses. BNT162b4 is a next-generation COVID-19 vaccine component designed to elicit T-cell immunity across epitopes. BNT162b4 encodes variant-conserved, immunogenic segments of the SARS-CoV-2 nucleocapsid, membrane, and ORF1ab proteins, targeting diverse human leukocyte antigen, or HLA, alleles.
A Phase 1 clinical trial (NCT05541861) to evaluate the safety, tolerability, and immunogenicity of BNT162b4 alone or in combination with BNT162b2 is ongoing.
COVID-19-Influenza Combination mRNA Vaccine Program - BNT162b2 + BNT161
The company and Pfizer are investigating respiratory combination vaccine approaches that aim to simplify immunization practices for healthcare providers and recipients, helping to reduce the burden of these diseases. Combination vaccines have been an effective approach in overcoming barriers to vaccination by allowing for simple scheduling and fewer injections compared to vaccinations administered separately and/or at different visits to healthcare providers.
In August 2024, the company and Pfizer announced top-line results from the Phase 3 clinical trial (NCT06178991) evaluating the companies' mRNA combination vaccine candidate against influenza and COVID-19 in healthy individuals aged 18-64 years. In this clinical trial, the vaccine candidate was compared to a licensed influenza vaccine and the companies' licensed COVID-19 vaccine given at the same visit. The primary immunogenicity objectives were to demonstrate that the antibody responses to influenza (hemagglutination inhibition) and to SARS-CoV-2 (neutralizing titer) elicited by the combination vaccine candidate were non-inferior to standard of care. The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain, despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines. No safety signals with the combination vaccine have been identified in an ongoing safety data review.
In November 2024, the company and Pfizer initiated a randomized, observer-blinded Phase 1/2 clinical trial (NCT06683352) to evaluate the safety, tolerability, and immunogenicity of the companies' mRNA combination vaccine candidate against influenza and COVID-19. The trial aims to enroll 1,350 healthy individuals aged 18 years and older.
In February 2025, the company and Pfizer initiated a randomized, double-blinded Phase 1/2 clinical trial (NCT06821061) to evaluate the safety, tolerability, and immunogenicity of the companies' mRNA vaccine candidates against influenza and COVID-19. The trial aims to enroll 2,050 healthy individuals aged 18 years and older.
Influenza Vaccine Program - BNT161
In 2018, the company and Pfizer entered into an agreement to collaborate on an mRNA program in influenza for an initial period of three years, which ended in 2021. Pfizer has since had the sole responsibility, authority, and control of the development, manufacturing, and commercialization of all candidates and products related to the program. Upon potential approval and commercialization, BioNTech is eligible to receive royalties on Pfizer's sales.
A Pfizer-initiated randomized Phase 3 clinical trial (NCT05540522) to evaluate the efficacy, safety, tolerability, and immunogenicity of an mRNA influenza immunotherapy candidate has been completed.
Pfizer is developing second-generation candidates with the goal of improving immunogenicity and potentially breadth of protection, including new trivalent formulations that match updated recommendations by the WHO and the FDA's VRBPAC. These candidates are currently in Phase 2.
Herpes Simplex Virus Vaccine Program - BNT163
The company has an ongoing research collaboration with the University of Pennsylvania, or UPenn, under which it has the exclusive option to develop and commercialize mRNA vaccine candidates for various infectious disease candidates. This agreement was originally executed in 2018.
As part of this collaboration, the company has the exclusive license to a combination of three HSV antigens for use in a vaccine. This combination of HSV antigens has been further developed into an HSV mRNA vaccine candidate (BNT163), which the company is currently evaluating in a Phase 1 clinical trial. This controlled, dose-escalation Phase 1 clinical trial (NCT05432583) aims to evaluate the safety, tolerability, and immunogenicity for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. Part A (first-in-human, dose escalation) has been completed. Part B (dose evaluation) has completed dosing, and Part C (population expansion) will start enrollment across sites in the United States.
Tuberculosis Vaccine Program - BNT164
The company has collaborated with the Gates Foundation since 2019 to develop vaccine candidates aimed at preventing tuberculosis disease.
A randomized, controlled, dose-finding Phase 1 clinical trial (NCT05537038, Germany) evaluating BNT164 is fully enrolled and ongoing.
A randomized, controlled, dose-finding two-part Phase 1/2 clinical trial (NCT05547464, Republic of South Africa and Republic of Mozambique) evaluating BNT164 is ongoing. Part A of the Phase 1/2 trial is fully enrolled.
Both the Phase 1 and Phase 1/2 clinical trials are designed to assess the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against tuberculosis.
Malaria Vaccine Program - BNT165
The company’s malaria program aims to develop a well-tolerated and highly effective mRNA vaccine with durable immunity to prevent P. falciparum malaria infection, thereby aiming to reduce morbidity, mortality, and onward transmission. The company plans to assess several vaccine candidates, featuring components of known targets, such as circumsporozoite protein, or CSP, and conserved, immunogenic segments of liver stage-expressed proteins.
A first-in-human Phase 1 clinical trial (NCT05581641) to evaluate the safety, tolerability, and exploratory immunogenicity of the vaccine candidate BNT165b1, the first candidate from its BNT165 program, has been completed.
A randomized, dose escalation Phase 1/2 trial (NCT06069544) to evaluate the safety, tolerability, immunogenicity, and efficacy of a second investigational RNA-based vaccine candidate is on clinical hold by the U.S. FDA, as announced on March 4, 2025. BioNTech has complied with the hold by the FDA and, in accordance with the clinical trial protocol, has proactively paused the study. BioNTech is taking actions to address the U.S. FDA's requests and will work with the U.S. FDA to assess next steps.
Mpox Vaccine Program - BNT166
The company’s fully-owned BNT166 program aims to deliver an effective, well-tolerated, and accessible vaccine for the prevention of mpox. The multivalent BNT166 mRNA vaccine candidates encode surface antigens that are expressed in the two infectious forms of the mpox virus to efficiently prevent virus replication and infectivity. The program is supported through a partnership with CEPI to provide equitable access to the vaccine, if successfully developed and approved, in low- and middle-income countries.
A Phase 1/2 trial clinical trial (NCT05988203) evaluating the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates is ongoing. Phase 1 substudies are fully enrolled, and enrollment is ongoing for an open-label, Phase 2a substudy. The trial aims to enroll a total of 96 healthy participants with and without prior history of known or suspected smallpox vaccination.
Shingles Vaccine Program - BNT167
The company is collaborating with Pfizer to develop the first mRNA-based vaccine candidate against shingles (also known as herpes zoster). While there are currently approved vaccines for shingles, the goal is to develop an mRNA vaccine candidate that potentially shows high efficacy and better tolerability and is more efficient to produce globally.
A randomized, controlled, dose-selection Phase 1/2 clinical trial (NCT05703607) to evaluate the safety, tolerability, and immunogenicity of BNT167 in up to 900 healthy volunteers aged 50 through 69 years is ongoing.
Bacterial Vaginosis - BNT331
BioNTech R&D (Austria) GmbH, a wholly owned subsidiary of the company, is focused on developing novel anti-bacterial drugs to treat persistent bacterial infections. Its development programs are based on its proprietary LysinBuilder platform, which allows for the targeted development of precision anti-bacterials. The company’s development pipeline focuses on chronic bacterial infections where antibiotics fail to cure or destroy the natural microbiomes. A two-part, randomized, double-blind Phase 1 clinical trial (NCT06469164) is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BNT331 in healthy women and women diagnosed with bacterial vaginosis. It also aims to explore the efficacy of BNT331 in women diagnosed with bacterial vaginosis.
mRNA Formats
Optimized Uridine mRNA, or uRNA
The nucleotide sequence of mRNA determines the amino acid sequence of the protein. In addition, the nature of nucleosides used for the production of mRNA drugs can also influence recognition of the molecule by the immune system. The presence of naturally occurring uridine (U) in the company’s optimized uRNA makes it immunogenic by activating immune sensors. The company has further optimized its uRNA for immunogenicity of the encoded antigen (augmented presentation on MHC I and MHC II) and pharmacological activity (enhanced stability and translational efficiency). Immunogenicity of the mRNA is an added benefit when mRNA is used for immunotherapy applications, by acting as an immunotherapy adjuvant.
Nucleoside-modified mRNA, or modRNA
Immunogenic reactions against mRNA drugs need to be avoided in applications where therapeutic proteins are produced, such as in its RiboMab and RiboCytokine platforms. The company has profound expertise in incorporating naturally occurring modified nucleosides into its therapeutic mRNAs. It has demonstrated that the presence of a variety of modified nucleosides in the manufactured mRNA suppresses its intrinsic immune activation, while leading to superior protein production for long duration. Deimmunizing mRNA by incorporating modified nucleosides helps to avoid the production of anti-drug antibodies and to broaden the therapeutic application of these types of mRNA drugs.
Self-amplifying mRNA, or saRNA
The company’s saRNA drugs use the concept of viral mRNA replication, while not being infectious, disease-causing agents themselves. saRNA resembles conventional mRNA, encoding the protein of interest, but it also encodes an RNA-dependent RNA-polymerase, called replicase, that multiplies part of the mRNA within the target cell. Thus, lower amounts of saRNA are needed compared to a regular mRNA to obtain the same amount of active protein. As the company has demonstrated, its saRNA ensures high levels of sustained antigen production with a small amount of initial mRNA input. The company’s scientific team has designed this mRNA technology to act as a potent tool for prophylactic vaccination, with the potential for application in infectious diseases.
Trans-amplifying mRNA, or taRNA
The company has expanded its self-amplifying mRNA capabilities and developed a novel mRNA amplification technology, which separates amplification of the target mRNA and the replicase encoding mRNA. This advancement broadens the spectrum of applications by making the development of therapeutic and prophylactic mRNAs even more flexible, as the replicase can amplify multiple mRNAs, allowing the expression of multiple proteins with only one replicase encoding mRNA. In the case of vaccines, this allows the company to produce the replicase mRNA in advance for use with different vaccines.
mRNA Delivery Formulation Technologies
The company has deep and broad expertise in the targeted delivery of mRNA therapeutics. It is convinced that the development of suitable delivery formulations in conjunction with its own therapeutic mRNAs is a key competitive advantage.
The company’s main mRNA delivery formulations, each designed for different functions and optimized for therapeutic product needs, are described below:
Lipoplex nanoparticles, or lipoplex, or LPX, formulation
The company’s LPX formulation embeds the mRNA between a lipid bilayer and is used for its FixVac and iNeST platforms. The company uses a proprietary size- and charge-based non-viral LPX formulation that it has developed to deliver mRNA to dendritic cells in lymphoid compartments (such as the spleen) for optimal antigen presentation and immune response activation. A synchronized adjuvant effect is mediated by TLR7-triggering and type-l interferon-driven innate and adaptive immune stimulation. The company’s LPX formulation allows for intravenous administration of its investigational mRNA-based cancer immunotherapies. The LPX formulation protects mRNA from degradation outside of the cell and mediates its efficient uptake and expression of encoded antigens in various DC populations. The company’s LPX formulation technology is designed to deliver multiple antigens in parallel, enabling the induction of poly-specific T-cell responses. The company has demonstrated in the clinic that systemic DC targeting by mRNA-based cancer immunotherapies can result in potent activity against shared tumor-associated antigens at very low doses. Consequently, less material would be required for treating high patient numbers, making manufacturing potentially more cost-effective.
Lipid nanoparticles, or LNP, formulation
For other applications, the company encapsulates its mRNA into LNPs. These LNP formulations are suitable for the company’s RiboMab and RiboCytokine oncology therapies and its prophylactic vaccines against infectious disease.
The company’s COVID-19 vaccines are based on an LNP formulation platform encapsulating nucleoside modified RNA, which has blunted innate immune sensor activating capacity and thus augmented antigen expression. Encapsulation of the mRNA into LNPs enables its transfection into host cells after intramuscular injection. These LNP formulations are composed of four different lipids in a defined ratio. During the mixing of the mRNA and dissolved lipids, the lipids form nanoparticles encapsulating the mRNA. After injection, the LNPs are taken up by the cells, and the mRNA is released into the cytosol. In the cytosol, the mRNA is translated into the encoded viral protein.
Polymer nanoparticles, or polyplex, or PLX, formulation
The company’s portfolio also includes PLX formulations, in which the mRNA is bound to a polymer and then forms nanoparticles, which are being utilized in various of its discovery programs.
mRNA Platforms
The company is developing multiple mRNA-based therapeutics in the oncology space, including mRNA cancer immunotherapy programs (e.g., FixVac and iNeST), RiboMabs, and RiboCytokines, using different RNA formats and delivery formulations. The company has also implemented mRNA platforms for the development of infectious disease vaccines.
Sales, Marketing and Distribution
The company’s commercial organization focuses on supporting sales of its COVID-19 vaccine in Germany and Türkiye. The company’s commercial organization is responsible for promoting its products to healthcare providers and providing information to stakeholders, including governmental organizations, in Germany and Türkiye.
As a result of the company’s partnership with Pfizer, under which its commercialization responsibilities are limited to Germany and Türkiye, the company maintains a lean fixed cost base for its COVID-19 vaccine business.
The company’s commercial organization is also responsible for preparing and obtaining reimbursement from third-party payors, including governmental organizations, for its COVID-19 vaccine.
Other Certifications
BioNTech Diagnostics has a quality management system that is certified according to ISO 13485:2016, and JPT maintains an ISO 9001:2015 certified Quality Management System to allow production of European CE marked companion diagnostics.
Autolus Collaboration
License and Option Agreement
On February 6, 2024 (with effect as of February 13, 2024), the company entered into a License and Option Agreement, or the Autolus License Agreement, with Autolus Therapeutics plc’s wholly-owned subsidiaries Autolus Limited and Autolus Holdings (UK) Limited, which collectively are referred to as Autolus, pursuant to which Autolus granted to the company an exclusive, worldwide, sublicensable license, which is referred to as the Autolus License, to certain binders and to exploit products that express in vivo such binders, which are referred to as the Binder Licensed Products.
Biotheus Acquisition
On November 13, 2024, the company’s subsidiary, BioNTech Collaborations GmbH, entered into an agreement and plan of merger, or the Merger Agreement, with Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases.
DualityBio Global Strategic Partnership
In 2023, the company entered into three License and Collaboration Agreements with DualityBio, which are referred to as the DualityBio Agreements.
Fosun COVID-19 Vaccine Collaboration
On March 13, 2020, the company entered into a Development and License Agreement with Fosun Pharma for the development and commercialization in mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR, and in the region of Taiwan, or collectively the Fosun Collaboration Territory, of immunogenic compositions generated by BioNTech and comprising uridine RNA, modified RNA, and/or replicon technology for prophylaxis against SARS-CoV-2 in humans. This agreement is referred to as the Fosun Agreement.
Genentech iNeST Collaboration
Collaboration Agreement
On September 20, 2016, the company entered into a Collaboration Agreement with Genentech and F. Hoffman-La Roche Ltd, together with all amendments thereto, collectively referred to as the Genentech Collaboration Agreement, to jointly research, develop, manufacture, and commercialize certain pharmaceutical products that comprise neoepitope RNAs, or the Genentech Collaboration Products, which include its iNeST development candidates, for any use worldwide.
Genmab Next-generation Immunomodulator Collaboration
On May 19, 2015, the company entered into a License and Collaboration Agreement with Genmab, which was subsequently amended and supplemented by side letters, to jointly research, develop, and commercialize polypeptide-based bispecific antibodies against certain target combinations for the treatment of cancer worldwide, or the Genmab Agreement Field, using certain Genmab technology.
Government Regulation
The company is required to comply with strict data protection and privacy legislation in the jurisdictions in which it operates, including the General Data Protection Regulation (EU) 2016/679, or GDPR.
Intellectual Property
The original version of the company’s Comirnaty COVID-19 vaccine product, its Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, its bivalent version (Original and Omicron BA.4/BA.5), and its Omicron KP.2-adapted monovalent vaccine have been approved by the FDA in the United States for individuals aged 12 and older. In addition, both the original version of the company’s Comirnaty COVID-19 vaccine product, its Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, its bivalent vaccine, and its Omicron KP.2-adapted monovalent vaccine were also authorized by the FDA in the United States under EUA for individuals aged 6 months to <12 years.
As of January 1, 2025, the company’s overall owned and in-licensed patent portfolio included more than 480 patent families, each of which includes at least one filing in the United States or Europe, and several of which are pending or granted in multiple jurisdictions. The patent families include at least 405 patent families that are solely or jointly owned by BioNTech, including certain families acquired through its acquisitions and others that it has licensed from a third party.
mRNA Commercial Products and Product Candidates
The company’s COVID-19 vaccine. The company’s COVID-19 vaccine (BNT162b2), marketed as Comirnaty, is its most advanced mRNA product. It is currently sold in monovalent format (one mRNA) based on Omicron variants XBB.1.5, JN.1, and KP.2. The Omicron KP.2-adapted monovalent COVID-19 vaccine has received full FDA approval for individuals aged 12 years and older and EUA for individuals aged 6 months to 12 years. The company’s monovalent XBB.1.5, JN.1- and/or KP.2-adapted COVID-19 vaccines have received full and/or conditional marketing approval in various other jurisdictions. In Europe, all three versions (XBB.1.5, JN.1- and KP.2-adapted monovalent vaccines) have received marketing authorization for individuals aged 6 months and older.
Comirnaty and Other COVID-19 Vaccine mRNA Product Candidates
Both the company’s current and previously-marketed monovalent and bivalent COVID-19 vaccines utilize modified-nucleoside mRNA formulated in lipid nanoparticles and which encode an optimized SARS-CoV-2 full-length spike protein antigen.
The company’s platform patent filings relevant to its COVID-19 vaccines, collectively referred to as the ‘BNT162b2 Platform Filings’, include certain mRNA Structure Filings relating to features for increasing translation efficiency and/or stability of mRNA constructs (e.g., certain 3' UTR structures containing a specific sequence element, interrupted polyA tails, and certain 5' cap/cap proximal sequence combinations), including filings that are jointly owned by BioNTech and TRON; also relevant are certain mRNA Manufacturing Filings. Issued BNT162b2 Platform Filings have, and pending BNT162b2 Platform Filings, if issued, would have 20-year terms extending into the late 2020s to the early 2040s. The company also has undertaken various patent filings specifically related to the BNT162b2 structure (including as may be tailored based on particular SARS-CoV-2 variants), composition, formulation, packaging, use, and/or manufacture, collectively referred to as the BNT162b2 Filings, including filings that have arisen through collaboration with third parties, such as Pfizer. Such filings relevant to its COVID-19 vaccines, if issued, would have 20-year terms that would extend into the early 2040s.
The company’s MRT-CellScript Sublicenses grant it rights to use certain U.S. and European patents and applications relating to mRNA containing modified nucleosides, including as used in BNT162b2. The company also has a non-exclusive license from the National Institutes of Health granting it a right to use certain technology described in U.S. and European patent filings that may relate to SARS-CoV-2 spike (S) protein mutations that lock the S protein in an antigenically preferred prefusion conformation; such a variant is utilized in BNT162b2.
Additionally, the company has obtained third-party licenses to technologies relating to certain lipids and/or lipid nanoparticles and formulations used in BNT162b2, including a non-exclusive license from Acuitas granting use rights relevant to proprietary lipid nanoparticles and formulations used in BNT162b2.
Additional COVID-19 vaccine mRNA product candidates are being developed and tested in clinical trials, which share with BNT162b2 certain structural elements, and/or features of the composition, formulation, packaging, use, and/or method of manufacture. Thus, some or all of the BNT162b2 Platform Filings and/or BNT162b2 Filings, as well as the in-licensed rights discussed above with respect to BNT162b2, may be relevant to certain of these candidates. The company has also undertaken patent filings specifically related to structures and uses of certain such additional candidates, including BNT162b4, which includes a T-cell antigen mRNA encoding SARS-CoV-2 non-spike protein antigens that are highly conserved across a broad range of SARS-CoV-2 variants and were chosen based on its proprietary target prioritization platform and which is being assessed in combination with its monovalent and bivalent COVID-19 vaccine products, and BNT162b5, a bivalent product that includes RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 Original strain and an Omicron variant. Such filings specifically relevant to BNT162b4 or BNT162b5, if issued, would have 20-year terms that would extend into the early 2040s.
Oncology mRNA Product Candidates
Certain mRNA oncology product candidates are also in clinical development and involve various platforms. The company’s pipeline also includes mRNA product candidates for the treatment of certain infectious diseases beyond COVID-19, and mRNA product candidates for protein replacement therapy in certain rare diseases. The company currently has more than 10 clinical oncology programs in Phase 1 or Phase 2. The company’s most advanced clinical oncology programs involve its iNeST immunotherapy product candidates being developed with its collaborator, Genentech. The company also has FixVac product candidates in Phase 1 and Phase 2 clinical trials and has initiated Phase 1 clinical trials of its mRNA-based intratumoral immunotherapy developed through its collaboration with Sanofi.
FixVac
The company’s FixVac product candidates share many of the structural elements involved in its iNeST product candidates. Thus, some or all of the mRNA Structure Filings relevant to its iNeST product candidates and discussed below are also relevant to its FixVac product candidates. These patent filings, or the FixVac Platform Filings, include mRNA Structure Filings relating to antigen-MHC fusions, certain 5' cap structures, 3' UTR structures containing a specific sequence element, and interrupted polyA tails, which are solely or jointly owned by BioNTech or BioNTech's licensors. Issued FixVac Platform Filings have, and pending FixVac Platform Filings, if issued, would have, 20-year terms extending into the mid-2020s to the mid-2030s. While the company has pursued or obtained patent protection covering components of FixVac product candidates, manufacturing-related methods and/or formulations, it does not currently have any claims in its owned or in-licensed issued patents that cover the overall construct used in its FixVac product candidates.
The company’s patent portfolio further includes U.S. and other patent filings relating to combined uses of its FixVac and iNeST product candidates. Such issued patent filings have, and such pending patent filings, if issued, would have, 20-year terms that extend into 2033, and are jointly owned by BioNTech and TRON.
The company’s current clinical trials for FixVac product candidates are studying such product candidates in the treatment of various cancers. While the company does not currently have any claims in its owned or in-licensed issued patents that are directed to the use of its FixVac product candidates in the indications of these clinical trials, certain FixVac Platform Filings include specific references to treatment of these indications, and if issued, would have 20-year terms extending into the mid-2030s.
iNeST
The company’s patent filings relevant to its iNeST product candidates include mRNA Structure Filings relating to features for increasing antigen presentation (e.g., antigen-MHC fusions) and features for increasing translation efficiency and/or stability of mRNA constructs (e.g., certain 5' cap structures, 3' UTR structures containing a specific sequence element, and polyA tails of a particular length or interrupted polyA tails); mRNA Lipoplex Filings relating to negatively charged lipoplexes (e.g., for spleen targeting); and mRNA Manufacturing Filings, or collectively, the iNeST mRNA Platform Filings. While the company has pursued or obtained patent protection covering components of iNeST product candidates, manufacturing-related methods and/or formulations, it does not currently have any claims in its owned or in-licensed issued patents that cover the overall construct used in its iNeST product candidates.
The company’s patent portfolio further includes U.S. and other filings directed to the process of identifying neoantigens in patient samples and/or predicting those that will be immunoreactive in an iNeST immunotherapy product, or collectively, the Neoantigen Filings. Certain issued Neoantigen Filings have, and certain pending Neoantigen Filings, if issued, would have, 20-year terms that extend into the 2030s. Many of the Neoantigen Filings are solely owned by BioNTech, or jointly owned by BioNTech and TRON; its acquisition of Neon added various Neoantigen Filings, including both BioNTech U.S.-owned and in-licensed filings. BioNTech and TRON jointly own issued EP patent number 2714071, whose claims recite steps relating to neoantigen selection, that were unsuccessfully opposed by multiple third parties. Said third parties have unsuccessfully appealed the decision to reject such opposition, and the patent was maintained as granted. In addition, related EP patent number 3473267 with claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant polyepitopic polypeptide was unsuccessfully opposed by a single third party. Said third party has instigated appeal proceedings against this decision. Related EP patent number 3892295 from the same patent family with claims reciting steps relating to neoantigen selection for an RNA vaccine encoding a recombinant polyepitopic polypeptide is being opposed by a third party; claims in related U.S. cases are granted. If the company is unsuccessful in these opposition/appeal proceedings, the patent claims for its iNeST product candidates may be narrowed, or a patent may not issue at all.
The company is studying its iNeST product candidates for the treatment of metastatic melanoma, and adjuvant pancreatic and bladder cancers in Phase 2 clinical trials. Certain iNeST mRNA Platform Filings and Neoantigen Filings cover treatment of each of these indications. However, the company does not currently have any claims in its owned or in-licensed issued patents that are directed to the use of iNeST product candidates in the indications of these clinical trials.
RiboMabs and RiboCytokines
The company owns or licenses a number of patent filings directed to its RiboMab and RiboCytokine programs. Many are owned solely by the company, some are jointly owned, and some have been acquired or licensed.
Patent filings relevant to the company’s RiboMab and RiboCytokine programs include certain mRNA Structure Filings that are also relevant to its iNeST and/or FixVac product candidates, including certain patent filings relating to 3' UTR structures containing a specific sequence element, and interrupted polyA tail structures; and patent filings under the MRT-CellScript Sublicenses relating to nucleoside-modified mRNAs, as well as certain patent filings the company has licensed from Acuitas and Genevant relating to lipid or non-liposomal formulations.
Infectious Diseases beyond COVID-19
The company has collaborated with third parties, including Pfizer and UPenn, to develop infectious disease mRNA vaccine candidates, some of which are currently in clinical trials at different phases, including mRNA vaccines against influenza (Phase 3) and HSV (Phase 1). The company is also developing its own mRNA vaccines against malaria, which have recently entered Phase 1 clinical trial.
Certain patent filings that might be useful to the company’s infectious disease mRNA vaccines include certain of the mRNA Structure Filings and the mRNA Lipid Nanoparticle/Polyplex Filings, as well as certain patent filings under the MRT-CellScript Sublicenses, which include patent filings directed to nucleotide-modified mRNAs. The company has also undertaken and continues to undertake filings specific to particular product candidates.
The company has also licensed technologies relating to certain lipids and/or lipid nanoparticles and formulations that may be useful for certain infectious disease mRNA vaccines.
Cell Therapy
Engineered Cell Therapy
The company’s engineered cell therapy product class features the use of chimeric antigen receptor, or CAR-, T cell or individualized T-cell receptors for oncology therapy. The company’s patent filings relevant to these platforms and product candidates, or the CAR-T/TCR Filings, are generally co-owned by the company, BioNTech US, and TRON. For example, the CAR-T/TCR Filings include patent filings directed to various CAR-T formats and methods of enhancing CAR-T cells by nucleic acid vaccination, as well as patent filings directed to compositions of matter comprising individualized T-cell receptors, for example. The CAR-T/TCR Patent Filings, if issued, would have patent terms that would extend into the mid-2030s to early 2040s.
Certain CAR-T programs involve CAR-T-cell product candidates that target different members of the claudin family. The company’s patent portfolio includes certain patent filings specifically relevant to its claudin-specific CAR-T-cell product candidates and are jointly owned by the company and TRON, or the Claudin-Specific CAR-T Cell Filings. The issued Claudin-Specific CAR-T-cell filings have, and the pending Claudin-Specific CAR-T-cell filings, if issued, would have, 20-year terms extending into the mid-2030s.
Activated T Cells
The company’s acquisition of Neon included technologies for using peripheral blood mononuclear cells, or PBMCs, (e.g., collected from apheresis material of patients) as a starting material to induce and/or expand ex vivo functional T cells specific for therapeutically relevant neoantigens.
The company’s BNT221 program is a personalized adoptive T-cell therapy, which uses multiple T-cell populations expanded from an individual patient's PBMCs that together target a set of neoantigens expressed by that patient's tumor.
Patent filings relevant to BNT221, referred to herein as the T-cell Induction/Expansion Filings, are generally solely owned by BioNTech US, or co-owned by BioNTech US and the Netherlands Cancer Institute (NKI). For example, the T Cell Induction/Expansion Filings include patent filings directed to therapeutic T cell compositions and methods of ex vivo induction and/or expansion of antigen-specific T cells. An issued subsisting T-cell Induction/Expansion Filing in the United States has, and pending subsisting T-cell Induction/Expansion Filings, if issued, would have, patent terms that extend into the late-2030s to early-2040s.
Antibodies
The company’s antibodies product class features bispecific checkpoint immunomodulators for oncology therapy, which are developed through collaboration with Genmab. The company’s development candidates include bispecific antibodies that are designed to activate 4-1BB upon simultaneous binding to CD-40 or EpCAM. The company’s patent portfolio includes certain patent filings relevant to such bispecific antibodies, or the Bispecific Checkpoint Modulator Filings, co-owned by the company and Genmab. Such Bispecific Checkpoint Modulator Filings, if issued, would have 20-year terms that would extend into the late 2030s.
The company’s collaboration with Genmab also includes the development of monospecific antibody candidates to address malignant solid tumors. For example, BNT313 is a CD27 antibody based on Genmab's proprietary HexaBody technology platform, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. The company has also undertaken and continues to undertake filings specific to particular product candidates.
The company owns patent assets acquired from MabVax Therapeutics Holding, Inc., or the MabVax Filings, that relate to various antibodies, including certain antibodies targeting sialyl Lewis A and ganglioside GD2, as well as nucleic acid encoding them. Issued MabVax Filings have, and the pending MabVax Filings, if issued, would have, 20-year terms that extend into the mid-2030s.
Small Molecule Immunomodulators
The company’s small molecule therapeutics product class features oncology treatment using small molecule product candidates that activate the immune system via TLR7 agonism. The company’s patent portfolio includes patent filings relevant to these TLR7 agonists, or the TLR7 Agonist Filings. Certain TLR7 Agonist Filings are directed to substituted imidazoquinolines, and, if issued, would have 20-year terms that would extend into the late 2030s.
Trademark Portfolio
Certain features of the company’s business and its product candidates are protected by trademarks. The company’s trademark portfolio includes, but is not limited to, Comirnaty, BioNTainer, FixVac, RiboCytokine, RiboMab, Recon, and Neo-Stim, including logo versions of some of these trademarks.
Research and Development
In the year ended December 31, 2024, the company’s research and development expenses were €2,254.2 million.
History
BioNTech SE was founded in 2008. The company was incorporated under the laws of the Federal Republic of Germany in 2008.
BioNTech Questions and Answers
Which sectors generate sales and which are the top 3 markets?
Pharmaceutical Sales: 100% (2025)
TOP 3 Markets:
USA: 45%
Germany: 20%
China: 15%
BioNTech SE generates its sales mainly from the pharmaceutical industry, particularly through the sale of vaccines and other biotechnological products.
The largest market for BioNTech is the USA, accounting for almos...
Pharmaceutical Sales: 100% (2025)
TOP 3 Markets:
- USA: 45%
- Germany: 20%
- China: 15%
BioNTech SE generates its sales mainly from the pharmaceutical industry, particularly through the sale of vaccines and other biotechnological products.
The largest market for BioNTech is the USA, accounting for almost half of the revenue. This is due to the strong demand for vaccines and strategic partnerships in the region. Germany follows as the second largest market, supported by the home advantage and a strong presence in the European market. China is the third largest market, strengthened by expansion and collaborations with local companies.
At which locations are the company’s products manufactured?
Production sites of BioNTech SE:
Mainz, Germany
Marburg, Germany
Idar-Oberstein, Germany
Singapore (planned expansion)
Massachusetts, USA (planned expansion)
BioNTech SE mainly produces its products in Germany, with key locations in Mainz, Marburg, and Idar-Oberstein. These sites are central to th...
Production sites of BioNTech SE:
- Mainz, Germany
- Marburg, Germany
- Idar-Oberstein, Germany
- Singapore (planned expansion)
- Massachusetts, USA (planned expansion)
BioNTech SE mainly produces its products in Germany, with key locations in Mainz, Marburg, and Idar-Oberstein. These sites are central to the production of mRNA-based vaccines and other biotechnological products.
The company also has plans to expand its production capacities in Singapore and Massachusetts, USA. These strategic steps aim to increase global production capacity and diversify supply chains to respond to the growing demand for their products.
What strategy does BioNTech pursue for future growth?
Focus on Oncology: BioNTech plans to intensify its research and development in the field of cancer immunotherapies.
Expansion of mRNA Technology: The company continues to invest in the development of mRNA-based vaccines and therapies for a variety of diseases.
International Expansion: BioNTech aims...
Focus on Oncology: BioNTech plans to intensify its research and development in the field of cancer immunotherapies.
Expansion of mRNA Technology: The company continues to invest in the development of mRNA-based vaccines and therapies for a variety of diseases.
International Expansion: BioNTech aims to expand its global presence through partnerships and the establishment of new production facilities.
BioNTech SE is pursuing a multi-track growth strategy that focuses on advancing its mRNA technology and its application in oncology. The company has already made significant progress in cancer research and plans to further expand these efforts through strategic partnerships and investments in research and development.
In addition to oncology, BioNTech is aiming to utilize mRNA technology for other therapeutic areas, including infectious diseases and rare genetic disorders. This diversification is intended to make the company more resilient to market fluctuations and tap into new revenue sources.
Another key aspect of the growth strategy is international expansion. BioNTech is working to expand its production capacities and enter new markets to ensure the global availability of its products. This includes establishing new production facilities and deepening existing partnerships.
Which raw materials are imported and from which countries?
Main raw materials: Lipids, nucleotides, enzymes
Countries of origin:
Lipids: USA, Germany
Nucleotides: China, USA
Enzymes: USA, Europe
BioNTech SE imports a variety of raw materials necessary for the production of their mRNA-based vaccines and therapies. Lipids, essential for the formulation of m...
Main raw materials: Lipids, nucleotides, enzymes
Countries of origin:
- Lipids: USA, Germany
- Nucleotides: China, USA
- Enzymes: USA, Europe
BioNTech SE imports a variety of raw materials necessary for the production of their mRNA-based vaccines and therapies. Lipids, essential for the formulation of mRNA vaccines, are mainly sourced from the USA and Germany. Nucleotides, the building blocks of mRNA, primarily come from China and the USA. Enzymes needed for the synthesis and modification of mRNA are mainly imported from the USA and Europe.
These raw materials are crucial for the production of mRNA vaccines and therapies, and BioNTech collaborates with various international suppliers to ensure a consistent supply. The geographical diversification of suppliers helps minimize the risk of supply shortages.
How strong is the company’s competitive advantage?
Market share in the mRNA vaccine market: 30% (2024, estimation)
R&D investments: 2.5 billion USD (2023)
Partnerships: Pfizer, Regeneron, Genentech
BioNTech SE has a significant competitive advantage in the field of mRNA technology, especially through the successful development and commercializ...
Market share in the mRNA vaccine market: 30% (2024, estimation)
R&D investments: 2.5 billion USD (2023)
Partnerships: Pfizer, Regeneron, Genentech
BioNTech SE has a significant competitive advantage in the field of mRNA technology, especially through the successful development and commercialization of the COVID-19 vaccine in collaboration with Pfizer. This partnership has not only brought substantial financial resources to BioNTech but also increased its global brand awareness.
The company heavily invests in research and development to expand its pipeline beyond vaccines into other therapeutic areas such as cancer immunotherapies. This diversification of the product pipeline is another strategic advantage that sets BioNTech apart from many competitors.
Additionally, BioNTech benefits from strategic partnerships with other leading biotechnology and pharmaceutical companies, which facilitate access to new technologies and markets. This strengthens the company's position in the global biotechnology market and secures its competitive advantage in the long term.
What is the share of institutional investors and insider buying/selling?
Institutional investor share: 55% (estimated for 2025)
Insider purchases/sales: No significant insider transactions in the last quarter (2025)
The institutional investor share in BioNTech SE is estimated to be around 55%. This reflects the continued interest of large investment funds and institution...
Institutional investor share: 55% (estimated for 2025)
Insider purchases/sales: No significant insider transactions in the last quarter (2025)
The institutional investor share in BioNTech SE is estimated to be around 55%. This reflects the continued interest of large investment funds and institutional investors who have confidence in the company's long-term prospects.
There were no significant insider transactions in the last quarter of 2025. This could indicate that the management and other insiders are satisfied with the current valuation of the company and see no need to change their positions.
What percentage market share does BioNTech have?
Market share of BioNTech SE: Estimate 15% in the mRNA vaccine sector (2025)
Major competitors in the mRNA vaccine sector:
Moderna, Inc. (NasdaqGS:MRNA): Estimate 20%
Pfizer Inc. (NYSE:PFE): Estimate 18% (in partnership with BioNTech)
CureVac N.V. (NasdaqGS:CVAC): Estimate 10%
Sanofi S.A. (Euronext:...
Market share of BioNTech SE: Estimate 15% in the mRNA vaccine sector (2025)
Major competitors in the mRNA vaccine sector:
- Moderna, Inc. (NasdaqGS:MRNA): Estimate 20%
- Pfizer Inc. (NYSE:PFE): Estimate 18% (in partnership with BioNTech)
- CureVac N.V. (NasdaqGS:CVAC): Estimate 10%
- Sanofi S.A. (Euronext:SAN): Estimate 8%
- GSK plc (LSE:GSK): Estimate 7%
BioNTech SE has secured a significant market share in the mRNA sector through its partnership with Pfizer and the success of the COVID-19 vaccine. The company's moat mainly consists of its advanced mRNA technology, existing partnerships, and rapid market deployment capacity.
Compared to its competitors, BioNTech has a strong technological advantage, especially in mRNA research and development. However, Moderna is a strong competitor with a similar technological focus and a robust pipeline of mRNA-based products.
Pfizer, as a partner of BioNTech, brings significant sales and marketing resources, further strengthening BioNTech's moat. Other companies like CureVac and Sanofi are also heavily investing in mRNA technologies but have not yet achieved the same market penetration.
Overall, BioNTech has a significant moat, but the competition is intense, and continuous innovation is crucial to maintain market leadership.
Is BioNTech stock currently a good investment?
Revenue growth 2024: 10%
Research and development expenses 2024: 2.5 billion euros
Net cash position 2024: 5 billion euros
BioNTech SE recorded a revenue growth of 10% in 2024. This shows that the company was able to tap into new sources of revenue, especially through the development of mRNA-based...
Revenue growth 2024: 10%
Research and development expenses 2024: 2.5 billion euros
Net cash position 2024: 5 billion euros
BioNTech SE recorded a revenue growth of 10% in 2024. This shows that the company was able to tap into new sources of revenue, especially through the development of mRNA-based therapies for other diseases, despite the decline in demand for COVID-19 vaccines.
The significant investments in research and development, amounting to 2.5 billion euros in 2024, underscore BioNTech's commitment to expanding its product pipeline. This could lead to new lucrative products in the coming years, further boosting growth.
With a net cash position of 5 billion euros, BioNTech is financially well-positioned to make future investments and withstand potential economic uncertainties. This solid financial foundation allows the company to make strategic decisions without relying on external financing.
In summary, BioNTech SE, due to its strong financial position, continuous investments in research and development, and ability to tap into new markets, represents an attractive investment opportunity. However, investors should keep an eye on the long-term development of mRNA technology and competition in this field.
Does BioNTech pay a dividend – and how reliable is the payout?
Dividend: No payout (as of 2025)
BioNTech SE has not distributed any dividends to its shareholders so far. The company has focused on reinvesting its profits in research and development as well as in expanding its production capacities. This strategy is typical for biotechnology companies operating...
Dividend: No payout (as of 2025)
BioNTech SE has not distributed any dividends to its shareholders so far. The company has focused on reinvesting its profits in research and development as well as in expanding its production capacities. This strategy is typical for biotechnology companies operating in a highly dynamic and research-intensive environment.
The reliability of a potential future dividend payment depends on several factors, including sustainable profitability, the company's strategic priorities, and general market conditions. As long as BioNTech primarily invests its resources in growth and innovation, it is unlikely that dividends will be paid in the short term.
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