Genmab A/S (Genmab) operates as an international biotechnology company.
The company has a pipeline of novel antibody-based products and product candidates designed to address unmet medical needs and improve treatment outcomes for patients with cancer and other serious diseases.
The company’s priorities are the commercial or late-stage programs epcoritamab, Rina-S and acasunlimab. Epcoritamab, marketed as EPKINLY in the U.S. and Japan and as TEPKINLY outside of those territories, is being devel...
Genmab A/S (Genmab) operates as an international biotechnology company.
The company has a pipeline of novel antibody-based products and product candidates designed to address unmet medical needs and improve treatment outcomes for patients with cancer and other serious diseases.
The company’s priorities are the commercial or late-stage programs epcoritamab, Rina-S and acasunlimab. Epcoritamab, marketed as EPKINLY in the U.S. and Japan and as TEPKINLY outside of those territories, is being developed and commercialized in collaboration with AbbVie. Epcoritamab is the first and only bispecific antibody approved in the U.S. and Europe to treat both relapsed or refractory (‘R/R’) diffuse large b-cell lymphoma (‘DLBCL’) and R/R follicular lymphoma (‘FL’). It is also approved in Japan for R/R DLBCL. Rina-S and acasunlimab are wholly owned by Genmab and entered Phase III clinical development in 2024.
The company’s full pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and ADCs. The company has 12 proprietary products or product candidates in clinical development, which comprise programs where the company retains at least 50% of product rights in collaboration with partners. These also include the company’s first proprietary commercial product, tisotumab vedotin, marketed as Tivdak. This is being developed and commercialized in collaboration with Pfizer. In 2024, Tivdak was granted full approval by the FDA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak is the first and only FDA approved ADC in this indication. In addition to the company’s marketed products and clinical product candidates, the company has multiple in-house and partnered pre-clinical programs.
In addition to Genmab’s own pipeline of product candidates, the company’s innovation and proprietary technology platforms are applied in the pipelines of global pharmaceutical and biotechnology companies. These companies are running clinical development programs with antibodies created by Genmab or created using Genmab’s proprietary DuoBody bispecific antibody technology platform. The six approved medicines created by Genmab or that incorporate Genmab’s innovation or technology platforms are daratumumab, marketed by J&J as DARZALEX (intravenous (‘IV’) formulation) and DARZALEX FASPRO or DARZALEX SC (SC formulation), approved in the U.S., Europe, Japan and other territories for the treatment of certain indications of MM and AL amyloidosis; amivantamab, marketed in the U.S., Europe and other territories by J&J as RYBREVANT for the treatment of certain adult patients with locally-advanced or metastatic non-small cell lung cancer (‘NSCLC’) with epidermal growth factor receptor (‘EGFR’) exon 20 insertion mutations; teclistamab, marketed in the U.S. and Europe by J&J as TECVAYLI for certain indications of MM; talquetamab, marketed in the U.S., Europe and other territories by J&J as TALVEY for certain indications of MM; SC ofatumumab, marketed in the U.S., Europe, Japan and other territories as Kesimpta by Novartis for the treatment of relapsing multiple sclerosis (‘RMS’); and teprotumumab, marketed in the U.S. and Japan as TEPEZZA by Amgen for the treatment of thyroid eye disease (‘TED’).
The company’s portfolio includes five proprietary antibody technology platforms: (i) the company’s DuoBody platform, which can be used for the creation and development of bispecific antibodies; (ii) the company’s HexaBody platform, which can be used to increase the potential potency of antibodies through hexamerization; (iii) the company’s DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization; (iv) the company’s HexElect platform, which combines two HexaBody molecules to maximize potential potency while minimizing potential toxicity by more selective binding to desired target cells; and (v) the company’s ADC platforms, which the company acquired through the purchase of ProfoundBio in May 2024. Antibody products created with these technologies may be used in a wide variety of indications including cancer and autoimmune, central nervous system and infectious diseases. These platforms play a key role in building the company’s product pipeline, enhancing the company’s collaborations and generating revenue. The company selectively enters into collaborations with other biotechnology and pharmaceutical companies that build its network in the biotechnology space.
Business Strategy
The key elements of the company’s strategy are to actively advance and expand its proprietary product pipeline; grow the company’s commercialization capabilities; strengthen the company’s product portfolio with strategic collaborations and potential acquisitions; leverage the company’s proprietary technology platforms; build the company’s translational research capabilities; and generate recurring revenue streams from collaborations.
Products and Product Candidates
In 2024, Genmab discontinued the GEN1047 (DuoBody-CD3xB7H4), GEN3017 (DuoBody-CD3xCD30) and GEN1056 (with BioNTech, BNT322) programs following a strategic re-evaluation of Genmab’s portfolio. For similar reasons, Genmab and BioNTech took the decision to discontinue the clinical development of GEN1053 (HexaBody-CD27, BNT313), including the Phase I/II clinical trial (NCT05435339) in solid tumors.
Epcoritamab
Epcoritamab is a proprietary bispecific antibody therapeutic created using the company’s proprietary DuoBody technology platform. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically validated target on malignant B-cells. The company used technology licensed from Medarex, Inc. (‘Medarex’) to generate the CD20 antibody forming part of epcoritamab. The company is co-developing, and co-commercializing in the U.S. and Japan, epcoritamab in collaboration with AbbVie. The companies have a broad clinical development program for epcoritamab including five ongoing Phase III trials and additional trials in planning. Epcoritamab is marketed as EPKINLY in the U.S., Japan, and other regions, and as TEPKINLY in Europe and other regions.
Epcoritamab for the Treatment of B-cell Malignancies
In March 2022, November 2023 and September 2024, the FDA granted orphan-drug designation and BTD respectively to epcoritamab for the treatment of FL.
Approvals and Results
R/R DLBCL. Epcoritamab received accelerated FDA approval in May 2023, as EPKINLY, for the treatment of adult patients with R/R DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy. EPKINLY was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. In June 2023, epcoritamab was added to the National Comprehensive Cancer Network (‘NCCN’) Clinical Practice Guidelines in Oncology for ‘B-cell Lymphomas’ (Version 4.2023) for third-line and subsequent therapy for patients with DLBCL, including patients with disease progression after transplant or chimeric antigen receptor (‘CAR-T’) cell therapy and as a Category 2A, preferred regimen for patients with histologic transformation of indolent lymphomas to DLBCL and no intention to proceed to transplant, including patients with disease progression after transplant or CAR-T cell therapy.
In September 2023, epcoritamab was granted both conditional marketing authorization by the European Commission and approval by the Japanese Ministry of Health, Labor and Welfare (‘MHLW’). In Europe epcoritamab, marketed as TEPKINLY, was approved as a monotherapy for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy. Similar to the accelerated FDA approval in the U.S., this marketing authorization is contingent upon verification and description of clinical benefit in a confirmatory trial. In Japan, epcoritamab, marketed as EPKINLY, was approved for the treatment of adult patients with certain types of R/R LBCL, including DLBCL, high-grade B-cell lymphoma (‘HGBCL’), primary mediastinal large B-cell lymphoma (‘PMBCL’) and follicular lymphoma grade 3B (‘FL3B’), after two or more lines of systemic therapy.
The approvals were supported by results from the LBCL cohort of the pivotal Phase II EPCORE NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including DLBCL. Approval in Japan was also based on the EPCORE NHL-3 clinical trial. Data from the EPCORE NHL-1 trial was presented as part of a late-breaking oral presentation selected for the Presidential Symposium at the European Hematology Association Annual Congress in June 2022.
R/R FL. Epcoritamab also received accelerated FDA approval in June 2024, as EPKINLY, for the treatment of adults with R/R FL after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s). In May 2024, epcoritamab was added to the NCCN Clinical Practice Guidelines in Oncology for ‘B-cell Lymphomas’ (Version 2.2024) for third-line and subsequent therapy for patients with FL as a Category 2A preferred regimen.
In August 2024, epcoritamab was granted conditional marketing authorization by the European Commission as a monotherapy for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. In March 2024, Genmab submitted a supplemental Japan New Drug Application (‘J-NDA’) to the MHLW in Japan for the same indication.
The approvals were supported by results from the FL cohort of the pivotal Phase II EPCORE NHL-1 trial. In June 2023 the company announced positive topline results from this cohort. The study cohort included 128 adult patients with R/R FL who received at least two prior lines of systemic therapy. 70.3% of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. The topline results from this cohort showed an ORR of 82% as confirmed by an independent review committee, which exceeded the protocol prespecified threshold for efficacy. The observed mDoR was not reached. No new safety signals were observed with epcoritamab in this study at the time of analysis. The most common treatment-emergent adverse event was CRS with 66.4% (1.6% grade >2). Aligned with the FDA’s Project Optimus, the optimization part of the trial continued to evaluate alternative step-up dosing regimens to mitigate the risk of CRS; preliminary data on the initial patients enrolled indicate a clinical improvement in CRS rate. The results from this cohort, along with the results from the optimization part of the trial, were presented during the American Society of Hematology (‘ASH’) Annual Meeting in December 2023.
Ongoing Phase III Trials
Along with the company’s collaboration partner, AbbVie, the company is evaluating SC epcoritamab for the treatment of B-cell malignancies, including DLBCL, FL and CLL in multiple clinical trials. Additional trials, including Phase III trials, are expected. Following are the ongoing Phase III trials:
EPCORE DLBCL-1 was the first Phase III trial of epcoritamab. The purpose of the open label, randomized, multi-center trial is to evaluate the efficacy of epcoritamab compared to investigator’s choice of chemotherapy in patients with R/R DLBCL who have failed or are ineligible for autologous stem cell transplant (‘ASCT.’) The trial is fully recruited and ongoing.
EPCORE DLBCL-2 is a Phase III randomized, open-label trial to evaluate the safety and efficacy of epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (‘R-CHOP’) compared to R-CHOP in patients with newly diagnosed DLBCL. The trial is fully recruited and ongoing.
EPCORE DLBCL-4 is a Phase III, open-label trial to evaluate the safety and efficacy of epcoritamab in combination with lenalidomide compared to rituximab plus gemcitabine and oxaliplatin in patients with R/R DLBCL. The trial is recruiting.
EPCORE FL-1 is a Phase III, open-label trial to evaluate the safety and efficacy of epcoritamab in combination with rituximab and lenalidomide (‘R2’) compared to R2 in patients with R/R FL. The trial is fully recruited and ongoing.
EPCORE FL-2 is a Phase III, open-label trial to evaluate the safety and efficacy of epcoritamab in combination with R2 compared to chemoimmunotherapy in patients with previously untreated FL. The trial is recruiting.
Tisotumab Vedotin
Tisotumab vedotin is an ADC directed to TF, a protein involved in tumor signaling and angiogenesis. TF is expressed in many solid tumors, including cervical, head and neck, lung, pancreatic, colon, endometrial, prostate, esophageal, ovarian and bladder tumors. Tisotumab vedotin combines the company’s human monoclonal antibodies (‘mAb’) that binds to TF and Pfizer’s ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E. The company used technology licensed from Medarex to generate the TF antibody forming part of tisotumab vedotin. The company is co-developing, and co-commercializing in the U.S., tisotumab vedotin in collaboration with Pfizer. In October 2024 the company decided, upon further strategic evaluation, to discontinue preparation for a Phase III study in second/third line squamous cell carcinoma of the head and neck.
Tisotumab vedotin for the Treatment of Cervical Cancer
Cervical cancer remains a disease with high unmet need despite advances in effective vaccination and screening practices to prevent and diagnose pre-/early-stage cancers for curative treatment. Recurrent and/or metastatic cervical cancer is a particularly devastating and mostly incurable disease; up to 15% of adults with cervical cancer present with metastatic disease at diagnosis, and for adults diagnosed at earlier stages who receive treatment, up to 61% will experience disease recurrence. It was estimated that in 2023, more than 13,960 new cases of invasive cervical cancer were diagnosed in the U.S. and 4,310 adults would die from the disease.
Approvals and Results
In September 2021, the FDA granted Genmab and Pfizer accelerated approval for tisotumab vedotin-tftv as Tivdak, the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin was approved under the FDA’s Accelerated Approval Program based on tumor response, durability of the response and the safety profile. The initial approval was based on the Phase II innovaTV 204 single arm trial in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Favorable topline results from the innovaTV 204 trial were announced in July 2020; results from the trial showed a 24% confirmed ORR by independent central review (95% Confidence Interval: 15.9% - 33.3%) with a median DoR of 8.3 months. The most common TEAEs (greater than or equal to 20%) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. In March 2024, tisotumab vedotin-tftv was added to the NCCN Clinical Practice Guidelines in Oncology for Vaginal Cancer under ‘Other Recommended Regimens’ as second-line or subsequent systemic therapy for patients with recurrent or metastatic squamous cell carcinoma/adenocarcinoma primary vaginal cancer.
In April 2024, the FDA granted approval to the supplemental BLA (‘sBLA’) for tisotumab vedotin-tftv for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This FDA action converts the September 2021 accelerated approval of tisotumab vedotin to a full approval. Tisotumab vedotin is the first ADC with demonstrated overall survival data to be granted full FDA approval in this patient population. The approval was based on the Phase III innovaTV 301 (ENGOT cx-12/GOG 3057) confirmatory trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received tisotumab vedotin, compared with chemotherapy alone. Favorable top line results from the innovaTV 301 trial were announced in September 2023. An Independent Data Monitoring Committee determined that overall survival (‘OS’) crossed the pre-specified efficacy boundary at the interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and ORR also demonstrated statistical significance. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with the known safety profile of tisotumab vedotin as presented in the U.S. prescribing information, and no new safety signals were observed. Based on these results, regulatory submissions were also made in Europe and Japan in 2024. In December 2024, the U.S. NCCN updated its Clinical Practice Guidelines in Oncology for Cervical Cancer with tisotumab vedotin-tftv changing from a category 2A to a category 1. Tisotumab vedotin-tftv plus pembrolizumab was also added as an option for PD-L1 positive tumors.
Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB)
Acasunlimab is a proprietary bispecific antibody designed to target programmed death ligand 1 (‘PD-L1’)-and 4-1BB. PD-L1 is a validated target that is expressed on tumor cells. 4-1BB is a trans-membrane receptor belonging to the tumor necrosis factor (‘TNF’) receptor super-family and is expressed predominantly on activated T-cells. In pre-clinical settings, acasunlimab promoted conditional T-cell activation in a tumor-specific manner by simultaneous activation and release of the key inhibitory brake. Pre-clinical trials also indicated a release of T-cell inhibition through the programmed cell death protein (‘PD-1’)//PD-L1 axis, including in the absence of 4-1BB, strong co-stimulation via the agonistic activity of 4-1BB and T-cell clonal expansion. Acasunlimab was co-developed in collaboration with BioNTech SE (‘BioNTech’) under an agreement in which the companies shared all costs and future potential profits for acasunlimab on a 50:50 basis. In August 2024, BioNTech opted not to participate in the further development of the acasunlimab program under the parties’ existing License and Collaboration Agreement for reasons related to BioNTech’s portfolio strategy. Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab and the program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Acasunlimab is being developed for the treatment of solid tumors using the company’s proprietary DuoBody technology platform and PD-L1 antibody and BioNTech’s 4-1BB antibody. Phase II data was presented at the 2024 American Society of Clinical Oncology (‘ASCO’) Annual Meeting of acasunlimab as a single agent or in combination with pembrolizumab for the treatment of relapsed/refractory metastatic NSCLC after treatment with standard of care therapy with an immune checkpoint inhibitor (‘CPI’). In PD-L1 positive patients with metastatic NSCLC following progression on prior CPI treatment, acasunlimab plus pembrolizumab dosed every six weeks (‘Q6W’) showed a manageable safety profile and promising efficacy, with durable disease control and median overall survival of 17.5 months and a 12-month overall survival rate of 69%.
Ongoing Phase III Trial
The first Phase III trial of acasunlimab was initiated in November 2024. The objective of this randomized, open-label, multicenter trial is to determine the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in patients with PD-L1-positive metastatic NSCLC who have been treated with PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the metastatic setting. The trial is recruiting.
Rina-S
Rina-S, acquired as part of the purchase of ProfoundBio, is a novel folate receptor a (‘FRa’)-targeted topoisomerase 1 (‘TOPO1’) ADC being evaluated for the potential treatment of ovarian cancer and other FRa-expressing cancers. Dose escalation data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FRa expression levels.
Platinum-Resistant Ovarian Cancer. In January 2024, Rina-S was granted FTD by the FDA for the treatment of FRa-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. Phase II data of Rina-S in platinum-resistant ovarian cancer (‘PROC’) was presented at the European Society of Medical Oncology Congress 2024 (‘ESMO’). Rina-S showed manageable safety with no signals of ocular toxicities, neuropathy or interstitial lung disease. It also showed encouraging antitumor activity with a confirmed overall response rate of 50% at the recommended Phase II dose of 120mg/m2.
Solid Tumors. A Phase I/II trial of Rina-S in advanced solid tumors is ongoing.
Ongoing Phase III Trial
The first Phase III trial of Rina-S was initiated in December 2024. The randomized open-label trial is evaluating Rina-S versus treatment of investigator's choice chemotherapy in patients with PROC. The trial is recruiting.
DuoBody-CD40x4-1BB (GEN1042/BNT312)
DuoBody-CD40x4-1BB is a proprietary bispecific antibody designed to conditionally activate both CD40-expressing antigen-presenting cells and 4-1BB-expressing T-cells using an inert DuoBody format. In pre-clinical settings DuoBody-CD40x4-1BB was shown to conditionally increase proliferation of activated T cells in the presence of CD40-expressing cells in vitro. DuoBody-CD40x4-1BB induced T-cell proliferation upon crosslinking of CD40- and 4-1BB-expressing cells and the binding of only the CD40 arm or the 4-1BB arm had no effect on T-cell proliferation. The company is co-developing DuoBody-CD40x4-1BB in collaboration with BioNTech under an agreement in which the companies share all costs and future potential profits for DuoBody-CD40x4-1BB on a 50:50 basis. DuoBody-CD40x4-1BB is being developed for the treatment of solid tumor malignancies using Genmab’s proprietary DuoBody technology platform and BioNTech’s CD40 and 4-1BB antibodies.
HexaBody-CD38 (GEN3014)
HexaBody-CD38 is a novel human CD38 monoclonal antibody product incorporating the company’s HexaBody technology. In pre-clinical models of hematological malignancies HexaBody-CD38 demonstrated enhanced complement-dependent cytotoxicity (‘CDC’) and showed potent anti-tumor activity.
In June 2019, Genmab entered into an exclusive worldwide license and option agreement with J&J to develop and commercialize HexaBody-CD38. In March 2021 the company initiated a Phase I/II clinical trial of HexaBody-CD38 for the treatment of hematologic malignancies. Preliminary dose-escalation results from the trial were presented at the ASH Annual Meeting in December 2022. This was followed by preliminary results from a dose-expansion cohort, which was presented at the ASH Annual Meeting in December 2023. This study includes an arm comparing HexaBody-CD38 to daratumumab in CD38 monoclonal antibody-naïve R/R MM patients.
In December 2024, per the terms of the agreement between Genmab and J&J, Genmab submitted a data package to J&J, comparing HexaBody-CD38 to daratumumab in CD38 monoclonal antibody-naïve R/R MM patients. This data will be used to inform J&J’s decision on whether to exercise its option to receive a worldwide license to develop, manufacture, and commercialize HexaBody-CD38.
DuoBody-EpCAMx4-1BB (GEN1059/BNT314)
DuoBody-EpCAMx4-1BB, jointly owned by Genmab and BioNTech and created using Genmab’s DuoBody technology platform, is a bispecific antibody aimed at boosting antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity. DuoBody-EpCAMx4-1BB is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for DuoBody-EpCAMx4-1BB on a 50:50 basis. A Phase I/II clinical trial of DuoBody-EpCAMx4-1BB in solid tumors is recruiting.
HexaBody-OX40 (GEN1055/BNT315)
HexaBody-OX40, jointly owned by Genmab and BioNTech and created using Genmab’s HexaBody technology platform, is an immune-modulating OX40 agonist antibody designed to promote immunity by enhancing T-cell responses through FcgammaR-independent OX40 clustering on T cells. HexaBody-OX40is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for HexaBody-OX40 on a 50:50 basis. A Phase I/II clinical trial of HexaBody-OX40 in solid tumors is recruiting.
GEN1160
GEN1160 was acquired as part of the company’s purchase of ProfoundBio. It is a CD70-targeted ADC. CD70 is a protein expressed on both solid tumors and hematological malignancies. A Phase I/II clinical study of GEN1160 in advanced renal cell carcinoma, nasopharyngeal carcinoma and NHL is recruiting.
GEN1107
GEN1107 is a PTK7-targeted ADC. PTK7 is a clinically validated ADC target with broad solid tumor expression, particularly in tumor-initiating cells. A Phase I/II clinical study of GEN1107 in advanced solid tumors is recruiting.
DuoBody- FAPaxDR4 (GEN1057)
DuoBody-FAPaxDR4 is a bispecific antibody-based investigational medicine created using Genmab’s DuoBody technology platform. DuoBody-FAPaxDR4 is designed for the conditional transactivation of DR4 and thereby induction of apoptosis. A Phase I/II clinical trial of DuoBody-FAPaxDR4 in malignant solid tumors is recruiting.
GEN1286
GEN1286 is an ADC targeting EGFR and cMet, two validated cancer targets. A Phase I/II clinical study of GEN1286 in advanced solid tumors is recruiting.
Daratumumab (DARZALEX)
Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the U.S. and as DARZALEX SC in Europe for SC administration) is a human monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of MM cells and is also expressed by AL amyloidosis plasma cells. Genmab used technology licensed from Medarex to generate the CD38 antibody. Daratumumab is being developed and commercialized by J&J under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab. Daratumumab is approved in a large number of territories for the treatment of adult patients with certain MM indications and is the only approved therapy in the U.S., Europe, and Japan for the treatment of adult patients with AL amyloidosis.
Amivantamab
In July 2012, and as amended in December 2013, Genmab entered into a collaboration with J&J to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of these, J&J amivantamab, is a fully human bispecific antibody that targets EGFR and cMet, two validated cancer targets. The two antibody libraries used to produce amivantamab were both generated by Genmab. In collaboration with J&J, the antibody pair used to create amivantamab was selected. J&J is responsible for the development and commercialization of amivantamab. Amivantamab, marketed as RYBREVANT, is approved in certain territories, including the U.S., Europe, and other markets for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations.
Teclistamab
In July 2012, and as amended in December 2013, Genmab entered into a collaboration with J&J to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of the products subsequently created, discovered and developed by J&J is teclistamab, a bispecific antibody that targets CD3, which is expressed on T-cells and B-cell maturation antigen (‘BCMA’), which is expressed on mature B lymphocytes. J&J is responsible for the development and commercialization of teclistamab. Teclistamab, marketed as TECVAYLI, is approved in certain territories, including the U.S., Europe and other markets for the treatment of certain adult patients with R/R MM.
Talquetamab
In July 2012, and as amended in December 2013, Genmab entered into a collaboration with J&J to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of the products subsequently created, discovered and developed by J&J is talquetamab, a bispecific antibody that targets CD3, which is expressed on T-cells and G protein–coupled receptor, family C, group 5, member D (‘GPRC5D’), an orphan receptor expressed in malignant plasma cells. J&J is responsible for the development and commercialization of talquetamab. Talquetamab, marketed as TALVEY, is approved in certain territories, including the U.S., Europe, and other markets for the treatment of certain adult patients with R/R MM.
Ofatumumab
Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. Genmab used technology licensed from Medarex to generate the CD20 antibody. Ofatumumab, marketed as Kesimpta, is approved in territories, including the U.S., Europe, and Japan for the treatment of certain adult patients with RMS. Ofatumumab is the first B-cell therapy that can be self-administered by patients using the Sensoready autoinjector pen, once monthly after starting therapy. Ofatumumab is being marketed worldwide by Novartis under a license agreement between Genmab and Novartis.
Teprotumumab
Teprotumumab, approved by the FDA under the trade name TEPEZZA, is a human monoclonal antibody that targets the Insulin-like Growth Factor 1 Receptor (‘IGF-1R’), a well-validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody. The antibody was created by Genmab under a collaboration with Roche and development and commercialization of the product is now being conducted by Amgen under a sublicense from Roche.
Partnered Candidates
The company’s collaboration partners have multiple product candidates in clinical development through collaboration agreements with the company. These include products that are being developed in collaboration with BMS, ADC Therapeutics SA (‘ADC Therapeutics’), Lundbeck, Provention Bio Inc., (‘Provention Bio’) (now owned by Sanofi S.A. (‘Sanofi’)), Global Blood Therapeutics, Inc. (now owned by Pfizer) and Novo Nordisk.
Technology Platforms
DuoBody Platform
The DuoBody platform is the company’s proprietary platform for the discovery and development of bispecific antibodies. Bispecific antibodies bind to two different epitopes (or ‘docking’ sites) either on the same, or on different targets (also known as dual-targeting). Dual-targeting may improve binding specificity and enhance therapeutic efficacy or bring two different cells together (for example, engaging a T-cell to kill a tumor cell). Bispecific antibodies generated with the company’s DuoBody platform can be used for the development of therapeutics for diseases, such as cancer, hemophilia and autoimmune, infectious, cardiovascular and central nervous system diseases. DuoBody molecules are designed to combine the benefits of bispecificity with the strengths of conventional antibodies, which allows DuoBody molecules to be administered and dosed in the same way as other antibody therapeutics. Based on a proof-of-concept study, the company’s DuoBody platform generates bispecific antibodies via a versatile and broadly applicable process that is easily performed at high throughput, at standard bench, as well as on a commercial manufacturing scale. The company uses the DuoBody platform to create its own bispecific antibody programs and the company actively seeks collaboration partners interested in developing antibody therapeutics using the company’s DuoBody technology. The company has a number of commercial collaboration partners for the DuoBody technology, including J&J, BioNTech, AbbVie and Novo Nordisk.
A number of the company’s proprietary bispecific antibodies created with the DuoBody technology are in clinical development. In addition, J&J has progressed a number of product candidates into clinical development through the company’s DuoBody collaboration, including amivantamab, teclistamab and talquetamab, which have been approved in the U.S., Europe and certain other markets.
ADC Technology Platforms
ADCs are antibodies with potent cytotoxic agents coupled to them. By using antibodies that recognize specific targets on tumor cells, these cytotoxic agents are preferentially delivered to the tumor cells. With Genmab’s acquisition of ProfoundBio the company inherited proprietary hydrophilic antibody-drug linker technology that blends innovative and proven methods to design ADCs leading to potentially enhanced therapeutic outcomes. This technology leverages two decades of insights into ADC pharmacology and optimization. These novel, highly hydrophilic and stable cleavable linkers are designed to mask the hydrophobicity of payloads, leading to ADCs with more ‘antibody-like’ pharmacokinetics. Initial focus has been on clinically proven targets where ADC viability has been established. The company’s intention is to pursue targets with clear opportunities for best- and/or first-in-class ADCs. The company also has the potential to combine this technology with Genmab’s proprietary DuoBody technology to create bispecific ADCs.
HexaBody Platform
The company’s HexaBody platform is a proprietary technology that is designed to increase the potency of antibodies. The HexaBody platform is designed to build on natural biology to strengthen the natural killing ability of antibodies while retaining regular structure and specificity. The HexaBody technology allows for the creation of potentially potent therapeutics by inducing antibody hexamer formation (clusters of six antibodies) after binding to their target antigen on the cell surface. The company has used the HexaBody platform to generate antibodies with an enhanced complement-mediated killing design, allowing antibodies with limited or absent killing capacity to be transformed into potent, cytotoxic antibodies. In addition to complement-mediated killing, the clustering of membrane receptors by the HexaBody platform may lead to subsequent outside-in signaling. The HexaBody technology creates opportunities to explore new product candidates, to repurpose drug candidates unsuccessful in previous clinical trials due to insufficient potency and may provide a useful strategy in product life cycle management. The HexaBody technology is broadly applicable and may be combined with other antibody technologies. The technology has the potential to enhance antibody therapeutics for a broad range of applications in cancer and infectious diseases.
The company’s HexaBody-based products in clinical development are HexaBody-CD38, for which the company entered into an exclusive license and option agreement with J&J, and HexaBody-OX40 which the company is co-developing with BioNTech.
DuoHexaBody Platform
The DuoHexaBody platform is a novel proprietary technology that combines the dual targeting design of the company’s DuoBody technology with the potential enhanced potency of the company’s HexaBody technology, creating bispecific antibodies with a target-mediated enhanced hexamerization design. DuoHexaBody-CD37 is the company’s only proprietary bispecific antibody created with DuoHexaBody technology. In September 2023 Genmab decided to discontinue the program due to a strategic evaluation of DuoHexaBody-CD37 within the context of the company’s portfolio. The decision was not based on any safety or regulatory concerns.
HexElect Platform
The HexElect platform is a novel proprietary technology that combines two different HexaBody molecules in order to selectively hit only those cells that express both targets by making the activity of complexes of HexaBody molecules dependent on their binding to two different targets on the same cell. The HexElect platform maximizes potency while minimizing potential toxicity, potentially leading to more potent and safer products.
Manufacturing
The company has no involvement with the manufacturing process for its approved products in development with collaboration partners, DARZALEX, RYBREVANT, TECVAYLI, and TALVEY, which are handled by J&J; Kesimpta, handled by Novartis; and TEPEZZA, handled by Amgen, under the applicable agreements. The company’s partners Pfizer and AbbVie are responsible for the manufacturing processes for Tivdak and EPKINLY/TEPKINLY, respectively, under the applicable agreements.
Commercialization Strategy
The company’s approved products in development with collaboration partners are DARZALEX, RYBREVANT, TECVAYLI, and TALVEY marketed by J&J, Kesimpta marketed by Novartis and TEPEZZA marketed by Amgen, under worldwide license agreements with the company, or in the case of TEPEZZA, under a sublicense from Roche. The company receives royalties from J&J, Novartis and Roche based on net sales of DARZALEX, RYBREVANT, TECVAYLI, TALVEY, Kesimpta and TEPEZZA, but the company is not involved with commercialization activities or strategy.
The company is continuing to develop and expand its commercialization capabilities to allow the company to market its own products for the indications and in the geographies the company determines would be most effective to create value for the company’s patients and shareholders. Genmab became a commercial-stage company with the launch of Tivdak for the treatment of second line plus recurrent or metastatic cervical cancer in 2021. Tivdak is developed and commercialized together with Pfizer. Effective January 1, 2025, Genmab and Pfizer agreed to amend the License and Collaboration Agreement and the Joint Commercialization Agreement for Tivdak, assigning Genmab sole responsibility for the development and commercialization of Tivdak for second line plus recurrent or metastatic cervical cancer in Europe and all other regions globally, excluding the United States and the China region. With this amendment, Genmab will continue to co-promote Tivdak with Pfizer in the U.S., and will continue to lead development and commercialization operational activities in Japan, when approved, which the company views as a promising commercial opportunity where modest commercial and medical affairs infrastructure has the potential to become a high-value investment given the low rates of cancer screening and human papillomavirus vaccinations. Pfizer will continue to lead commercialization activities in China, when approved.
In 2023, the company began commercializing EPKINLY together with AbbVie. The company is the lead in co-commercializing EPKINLY in the U.S. and Japan with AbbVie. AbbVie is responsible for commercialization in Europe and other markets as TEPKINLY.
Competition
The company is similarly aware, with respect to epcoritamab, of a number of other companies that have bispecific CD3xCD20-targeted product candidates in development for the treatment of B-cell malignancies, which are competing with epcoritamab. These include: Regeneron Pharmaceuticals’ odronextamab, which was approved by the EMA in August 2024 for third line plus LBCL and DLBCL and was filed in the U.S. for third line plus FL; and from Roche: mosunetuzumab, which has BTD and which received conditional marketing authorization as LUNSUMIO in Europe in third line plus FL in June 2022 and accelerated approval in the U.S. in December 2022; and glofitamab, which received accelerated approval (as COLUMVI) in both the U.S. and in Europe in June and July of 2023, respectively and was filed in 2024 for R/R DLBCL in combination with GemOx.
With respect to Rina-S competitors, Abbvie’s ELAHERE was the first folate receptor-alpha (FRa) targeting ADC approved, initially in the U.S. and recently in the EU.
Product and Technology Collaborations
Certain Collaborations for the company’s Proprietary Products
AbbVie Epcoritamab and Discovery Research Collaborations
In June 2020, the company entered into a Collaboration and License Agreement with AbbVie to jointly develop and commercialize epcoritamab and additional investigational bispecific antibody product candidates. In addition, under the agreement, the company agreed with AbbVie to enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer.
Genmab shares commercial responsibilities with AbbVie in the U.S. and Japan, while AbbVie is responsible for global commercialization outside of the U.S. and Japan. The company is the principal for net sales of epcoritamab in the U.S. and Japan and receives tiered royalties on remaining global sales outside these territories. The company is entitled to tiered royalties between 22% and 26% on net sales for epcoritamab outside the U.S. and Japan, subject to certain royalty reductions. Except for these royalty-bearing sales, the company shares with AbbVie profits from the sale of licensed products on a 50:50 basis. The company and AbbVie split 50:50 the development costs related to epcoritamab, while the company will be responsible for 100% of the costs for the discovery research programs up to the opt-in decision point.
For any product candidates developed as a result of the discovery research collaboration, the company will share responsibilities with AbbVie for global development and commercialization in the U.S. and Japan. Subject to certain requirements, the company has an option to co-commercialize these products, along with AbbVie, outside of the U.S. and Japan.
The company and AbbVie grant to each other co-exclusive licenses to use certain intellectual property that is necessary for or directly related to the development, manufacture or commercialization of the compounds being developed under the agreement and the resulting licensed products, as further described in the agreement. The licenses can be sublicensed to affiliates of the applicable licensee or to third-party sub-contractors meeting certain requirements or if otherwise approved.
Pfizer Tisotumab Vedotin Collaboration
In October 2011, the company entered into a license and collaboration agreement with Seagen, Inc. (‘Seagen’), now Pfizer per Pfizer’s acquisition of Seagen in December 2023, that granted the company rights to utilize Pfizer’s ADC technology with the company’s TF antibody in return for milestone payments and royalties. The company also granted Pfizer a right to exercise a co-development and co-commercialization option at the end of Phase I clinical development for tisotumab vedotin. In August 2017, Pfizer exercised this option to co-develop and co-commercialize tisotumab vedotin with the company. In October 2020, Genmab and Pfizer entered into a Joint Commercialization Agreement where Genmab would co-promote tisotumab vedotin, marketed as Tivdak, in the U.S., and lead commercial operational activities and record sales in Japan, while Pfizer would lead operational commercial activities in the U.S., Europe and China with a 50:50 profit split in those markets. In all other markets, if any, Pfizer would be responsible for commercializing tisotumab vedotin and Genmab would receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. Effective January 1, 2025, Genmab and Pfizer agreed to amend the License and Collaboration Agreement and the Joint Commercialization Agreement for Tivdak, assigning Genmab sole responsibility for the development and commercialization of Tivdak for second line plus recurrent or metastatic cervical cancer in Europe and all other regions globally, excluding the United States and the China region. With this amendment, Genmab will continue to co-promote Tivdak with Pfizer in the U.S. and will record sales for Europe, Japan and rest of world markets (excluding the United States and the China region), once commercialized, and will provide royalties to Pfizer on net sales in the low teens. Pfizer will continue to lead commercialization activities in China, when approved. The companies will continue the practice of joint decision-making on the worldwide development and commercialization strategy for tisotumab vedotin. In September 2022 Pfizer and Zai Lab announced an exclusive collaboration and license agreement for the development and commercialization of Tivdak in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Pfizer received an upfront payment of $30 million and will receive development, regulatory and commercial milestone payments, as well as tiered royalties on net sales of Tivdak in the Zai Lab territory. Based on the company’s agreement with Pfizer, all upfront, milestone payments and royalties have been and will continue to be shared 50:50 with Genmab.
BioNTech Collaboration
In May 2015, the company entered into an agreement with BioNTech to jointly research, develop and commercialize bispecific antibody products using the company’s DuoBody technology platform and antibodies. Under the terms of the agreement, BioNTech provides proprietary antibodies against key immunomodulatory targets, while the company provides proprietary antibodies and access to the company’s DuoBody technology platform.
In July 2022, the company expanded this collaboration. Under the expansion, the companies will jointly develop and commercialize, subject to regulatory approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform.
Genmab and BioNTech have three product candidates in clinical development: DuoBody-CD40x4-1BB, HexaBody-OX40 and DuoBody-EpCAMx4-1BB. In the first half of 2024, Genmab and BioNTech jointly agreed to terminate the GEN1056 program and to discontinue the clinical development of GEN1053 (HexaBody-CD27) for strategic portfolio reasons. In August 2024, BioNTech opted not to participate in the further development of the acasunlimab program under the parties’ existing License and Collaboration Agreement for reasons related to BioNTech’s portfolio strategy. Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab and the program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech.
Collaborations for the company’s Partnered Products
J&J Daratumumab License and Development Agreement
In August 2012, the company entered into a global license, development and commercialization agreement with J&J, granting J&J an exclusive, sublicensable license to certain of the company’s patents, know-how and materials, owned by or licensed to the company, to research, develop, make, offer and sell worldwide certain licensed products containing the human mAb denoted ‘daratumumab,’ also known as HuMax-CD38 and DARZALEX. With respect to licensed technology, the company has given up the ability to develop or commercialize other products with affinity to the CD38 antigen target.
The company has issued patents and pending patent applications covering daratumumab in numerous jurisdictions, including patents issued in the U.S., Europe and Japan. The company’s issued U.S., European and Japanese patents covering daratumumab, after giving effect to issued U.S., European and Japanese PTEs and SPCs, expire in 2029, 2031, and 2030, respectively. J&J owns a separate patent portfolio related to the subcutaneous formulation of daratumumab used in DARZALEX FASPRO/DARZALEX SC, but a binding arbitration determined that the company is not entitled to royalties based on these separate patents.
Novartis Ofatumumab Collaboration
In December 2006, the company entered into a co-development and collaboration agreement with GlaxoSmithKline (‘GSK’), pursuant to which GSK obtained exclusive, worldwide rights to develop and commercialize ofatumumab. This agreement was subsequently amended in 2010. In 2015, GSK transferred the ofatumumab collaboration for oncology and autoimmune diseases to Novartis. Novartis is now responsible for the development and commercialization of ofatumumab in all potential indications. Novartis is fully responsible for all costs associated with developing and commercializing ofatumumab. Novartis has obtained approval for an SC formulation of ofatumumab for the treatment of RMS in the U.S., Europe, and Japan, among other territories.
Roche / Amgen Teprotumumab Collaboration
In May 2001, Genmab entered a research collaboration with Roche to develop human antibodies to disease targets identified by Roche. In 2002, this alliance was expanded.
Teprotumumab was initially developed in collaboration between Genmab and Roche, and later investigated under license from Roche by River Vision Development Corporation and Horizon Therapeutics for ophthalmic use. The product was approved under the brand name TEPEZZA in 2020 by the U.S. FDA for the treatment of TED and in 2024 by Japan's MHLW for the treatment of active or high clinical activity score (‘CAS’) TED. In October 2023, Amgen completed its acquisition of Horizon Therapeutics, including all rights to the development and commercialization of teprotumumab. Under the terms of Genmab’s agreement with Roche, Genmab receives a mid-single digit royalty on net sales of TEPEZZA, on a country-by-country basis, for 10 years following the first commercial sale in such country.
J&J DuoBody Collaboration (Amivantamab, Teclistamab and Talquetamab)
In 2012, and as amended in 2013, Genmab entered into a collaboration with J&J to create and develop bispecific antibodies using the company’s DuoBody platform.
Amivantamab, teclistamab and talquetamab have received regulatory approval.
Certain other Collaborations, Agreements and Enabling Technologies
J&J HexaBody-CD38 Collaboration
In June 2019, the company entered into an exclusive worldwide license and option agreement with J&J to develop and commercialize HexaBody-CD38, a next-generation human CD38 mAb product incorporating the company’s proprietary HexaBody technology. Under the terms of the agreement, the company has agreed to collaborate exclusively with J&J on HexaBody-CD38 and to fund research and development activities until completion of clinical proof-of-concept studies in MM and DLBCL. Based on the data from these trials, J&J may exercise its option and receive a worldwide exclusive license to certain of the company’s intellectual property and an exclusive sublicense to certain intellectual property that the company license from third parties, in each case, to develop, manufacture and commercialize HexaBody-CD38. The IND for HexaBody-CD38 was submitted to the FDA in October 2020. The first patient was dosed with HexaBody-CD38 in March 2021. In December 2024, per the terms of the agreement between Genmab and J&J, Genmab submitted a data package to J&J, comparing HexaBody-CD38 to daratumumab in CD38 monoclonal antibody-naïve R/R MM patients.
Medarex UltiMAb System License
In 1999, the company entered into a license agreement with Medarex, now a wholly owned subsidiary of BMS, pursuant to which the company received access to the UltiMAb technology, the KM Mouse technology and the right to obtain antibody-exclusive licenses for an unlimited number of antigens and own the worldwide development and commercialization rights to antibody products targeting such antigens. In addition, Medarex granted the company antigen-exclusive licenses in exchange for Genmab shares that are fully paid-up subject to, in case the products have been generated in the KM Mouse, pass-through of milestones and royalties payable by Medarex under its own license of the KM Mouse technology. The company’s principal obligation under this agreement is to make milestone and royalty payments in connection with any such antibody-exclusive licenses or in connection with use of the KM Mouse technology under this agreement. The company used technology licensed from Medarex to generate daratumumab, ofatumumab, tisotumab forming part of tisotumab vedotin, the CD20 antibody forming part of epcoritamab (DuoBody-CD3xCD20), and certain of the company’s other product candidates. Based on the type of license and technology used in their development, product candidates that are subject to future payment obligations under this license agreement include ofatumumab, epcoritamab (DuoBody-CD3xCD20), amivantamab (DuoBody-cMetxEGFR) and amlenetug (Lu AF82422), but do not include daratumumab, tisotumab vedotin and HexaBody-CD38. With respect to ofatumumab and amlenetug, Novartis and Lundbeck, respectively, have agreed to bear the majority of the company’s payments to Medarex under these agreements.
Other Collaborations and Agreements
The company has other active collaborations and agreements with a number of companies, including J&J, ADC Therapeutics, BMS, Lundbeck, Amgen, Immatics, Novo Nordisk, CureVac AG and argenx to create, develop and/or commercialize antibody candidates and/or license certain of the company’s product candidates and use of its technology platforms.
The company also licenses technologies from a number of other companies that the company uses or has used to contribute to the antibody products in the company’s pipeline. Key technologies include Pfizer’s ADC technologies, the OmniAb transgenic mouse and rat platforms from Open Monoclonal Technology, Inc., certain transgenic mouse technologies from Medarex, the rabbit antibody platform from MAB Discovery GmbH and certain expression systems used by Lonza for production of the company’s product candidates. Pursuant to certain of these licenses, the company or its collaboration partners are or may be obligated to pay small royalties for certain products generated or produced using these technologies upon commercialization of such products or product candidates. The company also licenses certain targets disclosed and developed from Immatics’ XPRESIDENT targets and T-cell receptor technology as part of a research collaboration and exclusive license agreement with Immatics to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. As part of this collaboration, Immatics is or may be eligible to receive certain milestone payments and tiered royalties on net sales.
Intellectual Property
Patents
As of December 31, 2024, the company held more than 3,047 patents and patent applications, including more than 89 issued U.S. patents and 150 U.S. patent applications. All of the company’s issued patents and patent applications are projected to expire between 2025 and 2044.
The company’s owned and licensed patents and patent applications are directed to daratumumab, ofatumumab, tisotumab vedotin, epcoritamab, the company’s product candidates, antibodies, the company’s proprietary technologies and other antibody based and/or enabling technologies. The company commonly seeks patent claims directed to compositions of matter, including antibodies, bispecific antibodies, and ADCs, as well as methods of using such compositions. When appropriate, the company also seeks claims to related technologies, such as antibody format technologies and linker-payloads suitable for ADCs. For daratumumab, ofatumumab, tisotumab vedotin, epcoritamab and each of the company’s product candidates, the company or its collaboration partners have filed or expect to file multiple patent applications. The company maintains patents and prosecute applications worldwide for technologies that the company has out licensed, such as the company’s DuoBody technology.
With respect to daratumumab, the company has issued patents and pending patent applications covering daratumumab in numerous jurisdictions, including patents issued in the U.S., Europe and Japan. The company’s patents do not begin to expire until March 2026. The issued U.S., European and Japanese PTEs and SPCs, expire in 2029, 2031 and begin to expire in 2030, respectively.
With respect to ofatumumab, the company’s issued patents covering ofatumumab began to expire in October 2023, with the U.S. composition of matter patent extended to May 2031. In addition, the company has PTEs granted in Japan which expire in 2028.
With respect to tisotumab vedotin, the company has issued patents and pending patent applications in numerous jurisdictions, including the U.S., Europe and Japan. The company’s issued U.S., European and Japanese patents covering the composition of matter for tisotumab vedotin do not begin to expire until June 2031. The company has filed a request for PTE in the U.S., covering the composition of matter for tisotumab vedotin which, if granted, would provide protection beyond June 2031. In addition to the company’s key composition of matter patents for tisotumab vedotin, the company has issued patents and pending patent applications in numerous jurisdictions relating to specific formulations, indications and combination therapies that may offer additional protection.
With respect to epcoritamab, the company has issued patents and pending patent applications in numerous jurisdictions, including the U.S., Europe and Japan. The company’s U.S., European and Japanese patent applications and issued patents covering the composition of matter for epcoritamab do not begin to expire until January 2035. In addition, the company has filed a request for PTE in the U.S. and Japan covering the composition of matter for epcoritamab which, if granted, would provide protection beyond 2035. In addition to the company’s key composition of matter patents for epcoritamab, the company has issued patents and pending patent applications in numerous jurisdictions relating to specific formulations, dosing regimens, indications and combination therapies that may offer additional protection.
Trademarks
As of January 1, 2025, the company and/or its subsidiaries owned approximately 383 trademark registrations and applications, hereof 33 U.S. trademark registrations and applications, including: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HexaBody; HuMax; DuoBody; DuoHexaBody and HexElect. ProfoundBio is a trademark of ProfoundBio (Suzhou) Co., Ltd. and Genmab A/S. Rina-S is a trademark of Genmab A/S. TIVDAK is a trademark of Seagen Inc. and Genmab A/S. EPCORE, EPKINLY and TEPKINLY are trademarks of AbbVie Biotechnology Ltd. and Genmab A/S. ARZERRA is a trademark of Novartis Pharma AG. Kesimpta is a trademark of Novartis Pharma AG or its affiliates. DARZALEX, DARZALEX FASPRO RYBREVANT, TECVAYLI, and TALVEY are trademarks of Johnson & Johnson. TEPEZZA is a trademark of Horizon Therapeutics Ireland DAC.
Government Regulation
The FDA, the EMA, the Japan Pharmaceuticals and Medical Devices Agency (‘PMDA’) and other regulatory authorities at the U.S. federal, state, and local levels, as well as in other countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of biologics such as those the company is developing.
The company’s product candidates must be approved by the FDA before they may be legally marketed in the U.S.
Any products manufactured or distributed by the company or its collaboration partners pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements upon the company and its third-party manufacturers.
FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon the company and any third-party manufacturers that the company or its collaboration partners may decide to use.
FDA’s ‘In Vitro Companion Diagnostic Devices’ guidance states that, for novel drugs such as the company, a companion diagnostic device and its corresponding drug should be approved or cleared contemporaneously by the FDA for the use indicated in the therapeutic product labeling.
History
Genmab A/S was founded in 1999.
