Merus N.V. operates as an oncology company that develops antibody therapeutics. Merus US, Inc. is a wholly-owned subsidiary of the company.
The company's pipeline of full-length, human, multispecific antibody candidates is generated from its proprietary technology platforms, which are able to generate a diverse array of antibody binding domains, or Fabs, against virtually any target. The company's antibody binding domains generally consist of a target-specific heavy chain paired with a common l...
Merus N.V. operates as an oncology company that develops antibody therapeutics. Merus US, Inc. is a wholly-owned subsidiary of the company.
The company's pipeline of full-length, human, multispecific antibody candidates is generated from its proprietary technology platforms, which are able to generate a diverse array of antibody binding domains, or Fabs, against virtually any target. The company's antibody binding domains generally consist of a target-specific heavy chain paired with a common light chain. Multiple binding domains can be combined to produce novel multispecific antibodies that bind to a wide range of targets and display novel and innovative biology. These platforms, referred to as Biclonics and Triclonics, allow the company to generate large numbers of diverse panels of bispecific and trispecific antibodies (Multiclonics), respectively, which can then be functionally screened in large-scale cell-based assays to identify those unique molecules that possess novel biology. The company’s Multiclonics are compatible with a range of linkers and payloads to generate antibody-drug conjugates (ADClonics) capable of binding two or three different targets with the potential for improved binding selectivity, internalization and cancer cell killing activity.
The company's technology platforms employ an assortment of patented technologies and techniques to generate human antibodies. The company utilizes its patented MeMo mouse to produce a host of antibodies with diverse heavy chains and a common light chain that are capable of binding to virtually any antigen target. The company uses its patented heavy chain and CH3 domain dimerization technology to generate substantially pure bispecific and trispecific antibodies. The company also employs its patented Spleen to Screen technology to efficiently screen panels of diverse heavy chains, designed to allow the company to more rapidly identify Biclonics and Triclonics therapeutic candidates with differentiated modes of action for pre-clinical and clinical testing.
Using the company’s Biclonics platform it has produced, and are currently developing, the following candidates: Petosemtamab (MCLA-158) for the potential treatment of solid tumors and MCLA-129, for the potential treatment of lung and other solid tumors. The United States Food and Drug Administration (FDA) granted accelerated approval to BIZENGRI (zenocutuzumab-zbco), the first and only treatment indicated for adults with either pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbors a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. Furthermore, the company has a pipeline of proprietary antibody candidates in pre-clinical development and intend to further leverage its Biclonics and Triclonics technology platforms to identify multiple additional antibody candidates and advance them to clinical development.
Strategy
The company’s business strategy is to successfully develop its lead bispecific antibody candidate petosemtamab, MCLA-158; successfully commercialize its most advanced bispecific antibody candidate, zenocutuzumab (Zeno), through its collaboration with partner therapeutics, indicated for adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are advanced unresectable or metastatic, and harbor a neuregulin 1 (nrg1) gene fusion, who have disease progression on or after prior systemic therapy. additionally, the company will explore other potential indications in non-nrg1 fusion cancers by targeting both HER2 and HER3; successfully develop its bispecific antibody candidate MCLA-129; accelerate the discovery and development of additional internal and collaboration-related Multiclonics, bispecific antibody candidates and trispecific antibody and multispecific, antibody drug conjugate (ADC), ADClonics candidates; and seek strategic collaborations.
Biclonics and Triclonics Candidate Portfolio
The company has bispecific candidates in clinical development, with a variety bispecific and trispecific candidates in pre-clinical development.
Biclonics and Triclonics Platforms
The company's two technology platforms use large-scale functional screening in molecular and cell-based assays to identify novel, innovative Biclonics and Triclonics with the specific characteristics desired for further development.
The company's Biclonics and Triclonics platforms allow it to approach cancer treatment through multiple innovative modes of action:
Blocking oncogenic growth factor signaling by disrupting the signaling pathways that drive tumor cell growth or resistance to monoclonal antibody therapy: This includes, for example, tumor cell growth driven by NRG1 fusions interacting with the HER3 receptor. Hard-to-target receptors that may drive tumor growth or escape can be targeted by the company's Dock and Block mechanism, whereby the binding of a tumor-associated target prevalent on cancer cells facilitates a second domain to bind and block lesser expressed targets that are critical for cancer growth.
Engaging an adaptive immune response by recruiting T-cells and/or modulating co-stimulation or checkpoint inhibition: The company can produce multispecific antibodies that are designed to simultaneously bind to the T-cell antigen CD3 or other effector cell engaging antigens, and/or tumor-associated targets, for a potentially potent T cell or other effector cell recruitment and engagement to selectively kill tumor cells.
Engaging the innate immune response through multiple mechanisms: The company can produce enhanced ADCC modifications in the Fc region of its Biclonics or Triclonics designed to facilitate the recruitment of immune effector cells, such as natural killer cells, or NK cells, and macrophages, to directly kill tumor cells. Specific binding domains engineered in multispecific antibodies can directly bind to macrophages and monocytes, as well as NK cells, each providing specific immune cell function to attack cancer cells.
Employing combinations of the above mechanisms: Using its platforms, the company can design antibodies to simultaneously target a growth factor receptor expressed by tumor cells and an immunomodulatory molecule involved in blocking and/or reactivating tumor-specific T cells. Biclonics and Triclonics can be designed to target growth factor receptors, like epidermal growth factor receptors (EGFR) and HER2, that are expressed on many tumors, while delivering an activation signal or checkpoint blockade to T cells.
The company uses its patented MeMo, Spleen to Screen, heterodimerization technology, human antibody generation, and production technologies to rapidly build large collections of Biclonics or Triclonics directed against particular target combinations. The company then tests these collections in cell-based functional assays to identify multispecific antibodies that have the potential for novel and innovative modes of action. The company selects the most potent or efficacious candidates and evaluates them in multiple in vitro and in vivo assays to identify lead candidates for clinical development.
The company’s Biclonics technology platform includes the following:
Human antibody generation: One of the company's platforms for generating human antibodies employs its patented transgenic common light chain technology, referred to as MeMo, which harbors human heavy chain variable region gene segments and a human common light chain in its germline. MeMo harnesses the power of the in vivo immune system to yield human antibodies with the potential for high affinity, specificity, optimal biophysical characteristics, and low immunogenicity. Upon immunization, MeMo is capable of generating large and diverse panels of human common light chain antibodies against a broad variety of targets. These human common light chain antibodies are then used to generate large and diverse panels of human multispecific antibodies capable of binding different targets of virtually any combination.
Patented dimerization technology and the full-length Immunoglobulin G format: The company's Biclonics consist of two different heavy chains that need to stably form, or heterodimerize, inside a manufacturing cell line. Using the company's patented dimerization technology, it employs amino acid residues with opposite charges in the CH3 domains of these heavy chains to efficiently drive the formation of the heterodimer bispecific antibody rather than the homodimer antibody consisting of two copies of the same heavy chain. In addition, the use of a single, or common, light chain in the company's human Biclonics antibodies ensures that each heavy chain pairs with the correct, common light chain to efficiently form the intended functional antigen binding regions. The combination of these approaches prevents the need for additional, more artificial techniques, such as the use of linkers or chemical reactions, to force the pairing of different parts of the bispecific antibody. Furthermore, the format is designed to retain favorable attributes of conventional human IgG mAbs, including their stability and predictability during manufacturing, as well as their long half-life and low immunogenicity during the treatment of patients. The resulting Biclonics are bispecific heterodimeric IgG antibodies that are designed to closely mimic IgG antibodies that are produced naturally by the immune system.
The Biclonics format also permits the company to make modifications to the Fc region of the IgG antibody in order to enhance or limit effector functions associated with this part of the molecule. This strategy has been successfully executed with conventional therapeutic mAbs. In order to enhance efficacy and promote immunotherapeutic activity, the company can use glycoengineered cell lines in production to generate Biclonics that are enhanced for ADCC, resulting in the improved ability to recruit NK cells and macrophages. This ADCC enhancement has been applied to the company's approved bispecific antibody BIZENGRI (zenocutuzumab-zbco), its lead antibody candidate, petosemtamab (MCLA-158), and to MCLA-129. In order to improve safety and tolerability, the company can modify its Biclonics to prevent the excessive release of signaling proteins called cytokines, which can overstimulate the immune system. This process is called Fc-silencing, and is designed to block the ability of the company's Biclonics to bind to certain protein receptors on cells, known as Fc receptors, which are associated with cytokine release.
High-Throughput Functional Screening: The company employs its patented Spleen to Screen technology to rapidly screen panels of new target-specific heavy chains that form common light chain binding domains, or it employs its already established panels of common light chain antibodies. To date, the company has discovered over 10,000 unique common light chain antibodies directed at more than 40 different antigens, including tumor-associated antigens, such as EGFR and c-MET; T-cell binding, stimulating, or co-stimulating proteins, such as CD3 and CD137 (also called 4-1BB); and other immune-cell engaging antigens. For example, the company has an established panel of more than 175 unique and novel anti-CD3 common light chain antibodies from which to discover and develop the next generation of T-cell engaging bispecific and trispecific antibodies. The company then generates DNA constructs that encode target-specific human antibodies and expresses them in mammalian cells. The common light chain format and proprietary dimerization modifications to the CH3 domain of the IgG promote the secretion of virtually pure Biclonics into the cell culture medium. The medium of thousands of cell cultures that each express a different Biclonics is harvested and individually used in high-throughput molecular and cell-based functional assays to identify Biclonics with specific novel characteristics for further development.
Triclonics Platform
The company's Triclonics technology is covered by existing Merus patents and pending patent applications. This format, along with the suite of technologies that underpin it, permits the development of therapeutic candidates designed to bind three targets with a single multivalent molecule. In pre-clinical studies and modeling, Triclonics have shown qualities similar to those of a natural IgG antibody, including favorable half-life, stability, low immunogenicity, and favorable developability characteristics. MeMo harnesses the power of the in vivo immune system to yield human antibodies with the potential for high affinity, specificity, optimal biophysical characteristics, and low immunogenicity, which can be combined into a single trispecific antibody produced with relatively high purity. The Triclonics platform employs the company's proprietary technologies to produce large panels of substantially pure trispecific antibodies. In addition, the company has engineered a panel of novel linkers that attach a third binding domain to the antibody. This panel of linkers varies in properties such as length and flexibility, and is empirically selected for stability and other drug-like properties, while remaining stable and predicted to have low immunogenicity. The linker panel provides another lever of flexibility in optimizing functional characteristics in the company's high-throughput screening while maintaining high quality, stability, and limiting the risk of immunogenicity.
One application of the Triclonics platform is as a T-cell engager for solid tumors. By binding to three targets, the company can generate Triclonics designed to specifically engage a combination of two tumor antigens for enhanced specificity, binding preferentially to tumor cells expressing both antigens, over normal tissues that may express either antigen, but not both or both at lower expression levels. In this construct, the third binding domain can, for example, engage an innate or adaptive immune effector cell protein to stimulate the killing of the tumor cell.
The company's process to select lead Triclonics leverages its patented MeMo and Spleen to Screen human antibody generation and heterodimerization technologies, along with its proprietary linkers based on natural structures to undertake high-throughput unbiased functional screening of Triclonics. With this approach, the company has been able to evaluate thousands of different trispecific antibodies targeting three different antigens to identify those unique combinations that have been observed pre-clinically to possess desired characteristics for further development.
ADClonics Platform
The company's ADClonics technology is covered by existing Merus patents and pending patent applications. This format, along with the suite of technologies that underpin it, permits the development of therapeutic candidates designed to bind two or more targets with a single multivalent molecule, which is compatible with a range of linkers and payloads to generate ADC-multispecific antibodies—ADClonics—having the potential to be more selective and potent than conventional monoclonal ADCs. By selectively targeting multiple tumor-associated antigens, ADClonics hold the potential to use avidity binding and enhanced internalization to promote more robust anti-tumor responses, and have the potential for less on-target off-tumor toxicity. The company is exploring this potential in a three-program collaboration with Biohaven, which has multiple linker and payload technologies available for combination with the company's bispecific antibody candidates.
Bispecific and Trispecific Antibody Candidate Portfolio
The company has three bispecific antibody candidates in clinical development, with additional bispecific and trispecific programs in pre-clinical development.
Petosemtamab (MCLA-158, EGFR x LGR5 Biclonics)
Petosemtamab is an investigational antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics for the potential treatment of solid tumors that is designed to bind to cancer stem cells expressing EGFR and leucine-rich repeat-containing G protein-coupled receptor 5 (LGR5). EGFR is a member of the HER family of receptor tyrosine kinases and is important for growth and survival of cancer stem cells, including those with RAS mutations, while LGR5 is a WNT target gene expressed in cancer cells with aberrations in the WNT signaling pathway and reported to be up regulated in a variety of cancers, including HNSCC, gastric cancer, NSCLC, colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Petosemtamab is designed to exhibit three independent mechanisms of action, including inhibition of EGFR-associated signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced ADCC and antibody-dependent cellular phagocytosis (ADCP) activity.
Development
In its pre-clinical studies, petosemtamab demonstrated superior growth inhibition and selectivity compared to the EGFR-targeting mAb, cetuximab. Petosemtamab was significantly more potent than cetuximab in inhibiting the growth of patient-derived CRC organoids. Additionally, petosemtamab was observed to be selectively more active in human tumor-derived organoids than in organoids derived from normal human colon. The activity of petosemtamab on the tumor organoid size was more than 100 times greater than on the normal colon organoids.
In its pre-clinical studies, petosemtamab further demonstrated significant induction of internalization of EGFR and LGR5, resulting in EGFR degradation, and elicited potential anti-tumor activity in patient-derived esophageal, gastric, and HNSCC xenograft models.
As of a March 6, 2024, data cutoff, 45 patients (pts) were treated. The company plans to provide updated efficacy, durability, and safety data from this cohort in the first half of 2025.
Zenocutuzumab (Zeno, MCLA-128, HER2 x HER3 Biclonics)
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes Merus’ Dock & Block mechanism to bind to HER2, and bind to and disrupt the interaction between HER3 and ligand, neuregulin (NRG1) or mutated form NRG1 fusion, in solid tumors. HER2, or human epidermal growth factor receptor 2, is amplified in many solid tumors and is associated with poor prognosis, and the activation of HER3, or human epidermal growth factor receptor 3, is associated with tumor progression and treatment resistance. On the surface of tumor cells, HER2 pairs, or dimerizes, with HER3, and the resulting pair drives malignant progression of HER2-expressing cancer cells. NRG1, which is the ligand for HER3, causes cancer cells to grow and become resistant to treatment with HER2-targeted therapies. In addition, the company has identified a rare, genetically defined patient population whose cancers harbor NRG1 fusions. The NRG1 gene encodes for neuregulin, the ligand for HER3. Fusions between NRG1 and other genes in the genome are rare genetic events occurring in solid tumors and are associated with activation of HER2/HER3 signaling and growth of cancer cells. The NRG1 fusion is a powerful driver of cancer cell growth.
Development
In the company’s pre-clinical studies, the administration of Zeno resulted in the inhibition of NRG-induced growth in cultures of cancer cells. Zeno also blocked activation of two key signaling pathways for the growth and survival of tumor cells more than Herceptin (trastuzumab) or the combination of Herceptin and Perjeta (pertuzumab) or experimental anti-HER3 mAbs.
In March 2024 the FDA accepted for priority review a Biologics License Application (BLA) for Zeno in patients with NRG1+ NSCLC and NRG1+ PDAC. In December 2024, the FDA approved BIZENGRI (zenocutuzumab-zbco), the first and only treatment indicated for adults with pancreatic adenocarcinoma or NSCLC that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In December 2024, the company announced a License Agreement with Partner Therapeutics (PTx) in which it has exclusively licensed to PTx the right to commercialize BIZENGRI (zenocutuzumab-zbco) for the treatment of NRG1+ cancer in the United States. Under the terms of the agreement, following a specified transition period, PTx will assume full rights to U.S. commercialization of BIZENGRI (zenocutuzumab-zbco) for the treatment of NRG1+ cancer.
The company continues to explore development opportunities for Zeno outside the field NRG1 fusion cancer.
MCLA-129 (EGFR x c-MET Biclonics)
MCLA-129 is an investigational Biclonics, designed to bind EGFR and c-MET, for the potential treatment of solid tumors. EGFR is an important oncogenic driver in many cancers. The upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. MCLA-129 has two distinct mechanisms of action. First, MCLA-129 is designed to block the signaling of EGFR as well as c-MET, in an effort to inhibit tumor growth and survival. Second, MCLA-129 utilizes ADCC-enhancement technology, which is designed for greater cell-killing potential.
MCLA-129 is being developed in collaboration with Betta Pharmaceuticals Co. Ltd. (Betta). Under the terms of the collaboration, Betta is responsible for the clinical development and commercialization of MCLA-129, if approved, in China, while the company retains all rights to MCLA-129 outside of China. In January 2021, Betta announced that the Chinese National Medical Products Administration had accepted its Investigational New Drug application (IND) for MCLA-129 injection, and in October 2021, Betta announced that the first patient was dosed in Betta’s sponsored phase 1/2 trial of MCLA-129 in China in patients with advanced solid tumors.
The company is developing MCLA-129 as a potential treatment for solid tumors, including NSCLC. The company presented a clinical update on MCLA-129 from ongoing expansion cohorts in NSCLC with c-MET exon 14 skipping mutations (METex14) at the 2024 ASCO Annual Meeting.
The company also remains interested in exploring partnerships for MCLA-129 with other companies to sufficiently resource the development of MCLA-129 and the potential benefits it may have for patients.
The company-initiated cohorts of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC in 2024.
Pre-clinical Discovery Programs
The company intends to further leverage its Biclonics, Triclonics, and ADClonics technology platforms to identify multiple additional antibody candidates and advance them to clinical development. Each of these antibody candidates is designed to bind to targets believed to be useful in the treatment of cancer, with the intention to establish efficacy and obtain information for submission to the FDA. Using its patented platforms, the company will continue to evaluate new targets and combinations to identify potential candidates with the highest therapeutic potential and select those candidates to be advanced into clinical trials.
Collaboration Agreements
As part of its business strategy, the company collaborates with a range of partners, including pharmaceutical, biotechnology, and diagnostic companies, as well as academic institutions. The company intends to continue seeking collaborations and license agreements to develop and commercialize therapeutics in order to exploit the potential of its Biclonics, Triclonics, and ADClonics technology platforms.
Incyte Corporation
The company has entered into a collaboration and license agreement (Incyte Collaboration Agreement) with Incyte Corporation (Incyte). Under the terms of the Incyte Collaboration Agreement, the company and Incyte have agreed to collaborate on the research, discovery, and development of monospecific or bispecific antibodies utilizing the company's proprietary Biclonics technology platform.
The company has the option to co-fund the development of products, if any, arising from one specified program, and subject to certain conditions, to a second specified program, in each case in exchange for a share of profits in the United States, as well as the right to participate in a specified proportion of detailing activities in the United States for one of such programs.
Eli Lilly and Company (Eli Lilly)
In 2021, the company entered into a collaboration and license agreement (the Lilly Collaboration Agreement) and a share subscription agreement (the Lilly Subscription Agreement) with Eli Lilly and Company, an Indiana corporation (Eli Lilly).
The company granted Eli Lilly an exclusive, worldwide, royalty-bearing, sublicensable license under certain patent rights and know-how to exploit certain compounds and products directed to designated targets in combination with CD3, or directed to such designated target(s) alone as a monospecific antibody or monospecific antibody drug conjugate, subject to rights granted by the company to third parties under one or more existing third-party agreements. The company also retains all rights not granted to Eli Lilly.
Ono Pharmaceutical Co., Ltd.
In April 2014, the company entered into a strategic research and license agreement with Ono, under which the company granted Ono an exclusive, worldwide, royalty-bearing license to research, test, make, use, and market a limited set of bispecific antibody candidates, if approved, based on the company's Biclonics technology platform, directed to two undisclosed targets.
On March 14, 2018, the company entered into a second contract research and license agreement with Ono. Pursuant to an exclusive option granted to Ono in the prior agreement executed in April 2014, Ono exercised its option to enter into the March 2018 agreement. The company granted Ono an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to research, test, make, use, and market bispecific antibody candidates based on the company's Biclonics technology platform against two undisclosed targets directed to a particular undisclosed target combination.
Betta Pharmaceuticals Co. Ltd.
On December 10, 2018, the company entered into a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), where the company granted Betta an exclusive license to develop and commercialize MCLA-129 in China. The company retains all rights outside of China. Under the terms of the agreement, Betta retained a contract manufacturing organization with experience in filing IND applications with U.S. authorities and clinical trial applications (CTAs) with European regulatory authorities in order to produce clinical trial materials for the Chinese market and the rest of the world.
Gilead Sciences
On March 5, 2024, the company entered into a collaboration, option, and license agreement (Gilead Collaboration Agreement) and a share subscription agreement (Gilead Subscription Agreement) with Gilead Sciences, Inc. (Gilead). Under the terms of the Collaboration Agreement, the company and Gilead agreed to collaborate on the use of Merus’ proprietary Triclonics platform to develop certain trispecific T-cell engaging multi-specific antibody products for the treatment of certain indications.
Partner Therapeutics
On November 27, 2024, the company entered into a License Agreement (the PTx License Agreement) with Partner Therapeutics, Inc., a Delaware corporation (PTx). Under the terms of the License Agreement, the company granted PTx (i) an exclusive, sublicenseable, royalty-bearing license under certain patent rights and know-how to (a) exploit zenocutuzumab for the treatment of NRG1+ cancer in the United States and (b) develop, manufacture, and commercialize companion diagnostic tests with respect to zenocutuzumab for the treatment of NRG1+ cancer in the United States, and (ii) a limited, non-exclusive, non-sublicenseable, royalty-bearing license under certain patent rights and know-how to commercialize zenocutuzumab for the treatment of NRG1+ cancer outside of the United States solely in connection with a named patient program for a limited time, until the company files for any regulatory approval for zenocutuzumab in any country outside the United States.
Manufacturing
The company's Biclonics technology platform relies on third parties for the manufacturing of its product candidates. The company relies on, and expects to continue to rely on, third-party contract manufacturing organizations (CMOs) for the supply of current good manufacturing practice-grade (cGMP-grade) clinical trial materials and commercial quantities of its antibody candidates and products, if approved. The company has a commercial production agreement for zenocutuzumab, which it is planning to transition to PTx. For its other product candidates, the company has contracted several biopharmaceutical CMOs for the clinical manufacture of MCLA-158, petosemtamab, and MCLA-129.
Sales and Marketing
In December 2024, Merus entered into an agreement with Partner Therapeutics (PTx) in which the company exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno) for the treatment of NRG1+ cancer in the United States. Under the terms of the agreement, following a specified transition period, PTx will assume full rights to U.S. commercialization of Zeno for the treatment of NRG1+ cancer. Future commercial strategy may include the use of strategic partners, distributors, a contract sales force, or the establishment of the company's own commercial infrastructure.
Competition
The company's closest competitors in this area include Genmab A/S, Janssen Pharmaceutical Companies, Regeneron Pharmaceuticals, Inc., Bicara Therapeutics, Exelixis, Inc., Pfizer, Inc., and Xencor, Inc.
Intellectual Property
The company's patent portfolio related to its bispecific antibody candidate zenocutuzumab comprises one application filed under the Patent Cooperation Treaty (PCT) on February 27, 2015, with two issued patents in Europe, one in the United States, and 14 other foreign jurisdictions. There are applications pending in Europe, the United States, and 8 other foreign jurisdictions, with an expected expiry not earlier than February 2035. Claims are directed to the zenocutuzumab composition of matter and methods of using zenocutuzumab to treat subjects having or at risk of having a HER2 and/or HER3 positive tumor. In addition, the company's portfolio includes nine PCT patent applications directed to methods of using zenocutuzumab, including in combination therapies to treat patients with cancer harboring NRG1 gene fusions and patients with certain forms of HER3 positive tumors. One of these PCT applications was filed on April 3, 2018, with issued claims in two foreign jurisdictions and applications pending in Europe, the United States, and 16 other foreign jurisdictions, with an expiry date not earlier than April 2038. Claims are directed to methods of treatment using zenocutuzumab, including in combination with an HER2 targeting agent in patients with an HER2/HER3 positive tumor, such as a tumor in the breast or brain. The second of these PCT applications was filed on April 3, 2018, with applications pending in Europe, the United States, and four other foreign jurisdictions, with an expiry date not earlier than April 2038. Claims are directed to methods of treatment using zenocutuzumab in patients having an HER2/HER3 positive tumor but not previously treated with a HER2 specific therapy or with a HER3 specific therapy. The third of these PCT applications was filed on April 3, 2018, with an issued patent in the United States, one foreign jurisdiction, and applications pending in Europe, the United States, and 17 other foreign jurisdictions, with an expiry date not earlier than April 2038. Claims are directed to methods of treating patients with cancers harboring NRG1 gene fusions. The fourth of these PCT applications was filed on May 17, 2018, with issued claims in Europe, the United States, and eight foreign jurisdictions, and applications pending in three other foreign jurisdictions, with an expiry date not earlier than May 2038. Claims are directed to methods of treatment using zenocutuzumab, including in combination with endocrine therapy for patients with cancers, such as hormone receptor positive breast cancer. The fifth of these PCT applications was filed on October 23, 2020, with issued claims in one foreign jurisdiction and applications pending in Europe, the United States, and eight other foreign jurisdictions, with an expiry date not earlier than October 2040. Claims are directed to methods of treatment using zenocutuzumab in patients with NRG1-fusion positive cancers, including in patients that progressed after having received prior treatment. The sixth of these PCT applications was filed on November 3, 2021, with applications pending in Europe, the United States, and three other foreign jurisdictions, with an expiry date not earlier than November 2041. Claims are directed to the treatment of patients with certain HER3 positive cancers using zenocutuzumab. The seventh of these PCT applications was filed on June 1, 2022, with applications pending in Europe, the United States, and three other foreign jurisdictions, with an expiry date not earlier than June 2042. Claims are directed to further identified NRG1 fusions, methods of detecting such, and methods of treatment using zenocutuzumab. The eighth of these PCT applications was filed on June 1, 2022, with applications pending in Europe, the United States, and two other foreign jurisdictions, with an expiry date not later than June 2042. Claims are directed to detecting NRG1 fusions using liquid biopsy assays and methods of treating identified patients using zenocutuzumab. The ninth of these PCT applications was filed on August 4, 2023, with a PCT application pending in one foreign jurisdiction, and an expiry date not earlier than August 2043. Claims are directed to the treatment of patients with castration-resistant prostate cancer.
The company's patent portfolio related to its CD3 technology comprises a first PCT application, filed on July 8, 2016, with issued patents in the United States, Europe, and 11 foreign jurisdictions, as well as applications pending in the United States, Europe, and seven foreign jurisdictions, with an expected expiry not earlier than July 2036. A second PCT application was filed on March 27, 2020, with applications pending in the United States, Europe, and 20 foreign jurisdictions, with an expected expiry not earlier than March 2040. Claims are related to the anti-CD3 binding domains, antibodies, their use, among other subject matter.
The company's patent portfolio related to its bispecific antibody candidate petosemtamab comprises one PCT application filed on October 21, 2016, with one issued patent in Europe, one issued in the United States, and 11 issued patents in foreign jurisdictions. There are applications pending in Europe, the United States, and nine other foreign jurisdictions, with an expiry not earlier than October 2036. Claims are directed to the petosemtamab composition of matter and methods of using petosemtamab in the treatment or prevention of various solid tumors. In addition, the company's portfolio includes seven PCT applications. One of these was filed on August 19, 2020, with issued claims in one foreign jurisdiction and applications pending in Europe, the United States, and 18 other foreign jurisdictions, with an expiry no earlier than August 2040. Claims are directed to a combination treatment with a topoisomerase I inhibitor to treat patients. The second PCT application was filed on April 23, 2021, with applications pending in Europe, the United States, and 18 other foreign jurisdictions, with an expiry no earlier than April 2041. Claims are directed to the treatment of patients having gastric, esophageal, and gastro-esophageal cancer, including certain dosing regimens. The third PCT application was filed on December 15, 2021, with applications pending in Europe, the United States, and 18 other foreign jurisdictions, with an expiry no earlier than December 2041, directed to the treatment of patients having head and neck cancer, including certain dosing regimens. The fourth PCT application was filed on December 16, 2021, with applications pending in Europe, the United States, and 15 other foreign jurisdictions, with an expiry no earlier than December 2041, directed to a pharmaceutical formulation that contains petosemtamab. The fifth PCT application was filed on October 6, 2022, with applications pending in Europe, the United States, and 18 foreign jurisdictions, with an expiry not earlier than October 2042, with claims directed to the treatment of patients having a cancer with high EGFR expression levels. The sixth PCT application was filed on December 23, 2023, with national phase entry due in May 2025, with an expiry no earlier than December 2043, with claims directed to a combination treatment using petosemtamab and an immune checkpoint inhibitor in patients having a cancer, including head and neck cancer. The seventh PCT application was filed on December 28, 2023, with national phase entry due in May 2025, with an expiry no earlier than December 2043, with claims directed to a combination treatment using petosemtamab and a chemotherapeutic agent in patients having a cancer, including colorectal cancer.
The company's patent portfolio related to its bispecific antibody candidate MCLA-129 comprises one PCT application filed on August 9, 2018, with one issued patent in Europe, one issued in the United States, and in two foreign jurisdictions. There are applications pending in the United States, Europe, and 20 other foreign jurisdictions, with an expiry of not earlier than August 2038. Claims are directed to the MCLA-129 composition of matter and methods of using MCLA-129 in the treatment or prevention of various solid tumors. In addition, the company's portfolio includes two PCT applications. One of these was filed on March 7, 2023, with applications pending in Europe, the United States, and three foreign jurisdictions, with an expiry not earlier than March 2043. Claims are directed to, among other things, the treatment of patients using a combination of MCLA-129 and a third-generation EGFR tyrosine kinase inhibitor. The second PCT application was filed on March 7, 2023, with applications pending in Europe, the United States, and 17 foreign jurisdictions, with an expiry not earlier than March 2043. Claims are directed to, among other things, the treatment of previously treated patients having cancer using MCLA-129.
The company's patent portfolio related to its bispecific antibody candidate MCLA-145 comprises one PCT application filed on September 22, 2017, with an issued patent in Europe and the United States, as well as 11 issued patents in a foreign jurisdiction. There are applications pending in the United States, Europe, and 16 other foreign jurisdictions, with an expiry not earlier than September 2037. Claims are directed to the MCLA-145 composition of matter and methods of using MCLA-145 in the treatment or prevention of various solid tumors. In addition, the company's portfolio includes two PCT applications. One of these was filed on December 3, 2021, with applications pending in the United States, Europe, and 9 foreign jurisdictions, related to dosage regimens and methods of treating patients with certain kinds of solid tumors, with an expiry no earlier than December 2041. The second PCT application was filed on January 24, 2023, with applications pending in the United States, Europe, and three foreign jurisdictions, with an expiry not earlier than January 2043. Claims are directed to, among other things, the treatment of patients having cancer using MCLA-145 and a PD-L1 or PD-1 inhibitor.
The company's patent portfolio related to its MeMo and common light chain transgenic animal consists of nine issued U.S. patents, five pending U.S. applications, three issued European patents that have been validated in many countries, and one pending European application. Additionally, there are 26 issued foreign patents and nine pending foreign applications, all with an expected expiry not earlier than June 2029. Claims are directed to a common light chain animal and methods of producing hybridomas, host cells, and antibodies relating to the use of a common light chain and by exposing the animal to an antigen.
The company's patent portfolio related to the efficient dimerization of heavy chains promoting efficient production of multispecific antibodies, binding domains, and mixtures of antibodies, as well as methods and host cells for recombinant production thereof, comprises two PCT applications filed on April 19, 2013. This has resulted in nine issued U.S. patents, one pending U.S. application, two issued European patents, two pending European applications, 38 issued foreign patents, and 21 pending foreign applications, all with an expected expiry not earlier than April 2033.
The company's patent portfolio related to its trispecific antibody technology comprises one PCT application filed on March 29, 2019, with one issued patent in the United States and two issued foreign patents, as well as pending applications in the United States, Europe, and 20 foreign jurisdictions, with an expiry no earlier than March 2039. Claims are directed to, among other things, a multivalent antibody format, including the Triclonics format.
The company's patent portfolio related to its Spleen to Screen technology consists of four issued U.S. patents, one pending U.S. application, one pending European application, and four issued foreign patents, along with one pending foreign application, all with an expected expiry not earlier than September 2032.
The company plans to continue expanding its intellectual property estate by filing patent applications directed to dosage forms, methods of treatment, and additional compositions created or identified from its ADClonics, Biclonics, and Triclonics technology platforms, as well as improvements to those platforms and the ongoing development of its antibody candidates.
The company's patent portfolio is intended to cover, but is not limited to, the composition of matter of its bispecific antibody candidates, their methods of use, and the ADClonics, Biclonics, and Triclonics technology platforms used to generate them. This portfolio also encompasses related technologies and other aspects of the inventions that are important to the company's business, including its MeMo mouse, common light chain generation platforms and techniques, Spleen to Screen technology, recombinant host cells capable of producing the company's antibody candidates, methods of purification, and heterodimerization, among other proprietary technology.
Government Regulation
The company's antibody candidates are expected to be regulated as biologics. Biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), as well as other federal, state, local, and foreign statutes and regulations. Both the FD&C Act and the PHS Act, along with their corresponding regulations, govern various aspects, including the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, distribution, reporting, advertising, and other promotional practices involving biological products.
The company is subject to the General Data Protection Regulation (GDPR) and also the United Kingdom (UK) GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in U.K. national law.
History
Merus N.V. was founded in 2003. The company was incorporated in 2003.
