Merus is at the forefront of cancer treatment innovation, leveraging its proprietary Multiclonics® platform to develop bispecific antibodies aimed at targeting specific cancer pathways. One of the key therapeutic candidates, Petosemtamab (MCLA-158), is designed to treat recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) by targeting both the epidermal growth factor receptor (EGFR) and LGR5. This bispecific antibody is currently undergoing multiple Phase 3 clinical trials to evaluate its efficacy in combination with pembrolizumab, as well as in comparison to other monotherapy options for patients who have previously received treatment. The ongoing research highlights Merus's commitment to addressing unmet medical needs in oncology through innovative therapeutic strategies.

Another significant candidate in Merus's pipeline is Zenocutuzumab (MCLA-128), a bispecific antibody targeting HER2 and HER3, which is being investigated for its effectiveness in treating solid tumors with NRG1 fusions. The eNRGy trial, a Phase 1/2 study, is currently enrolling patients with NRG1+ cancers, including non-small cell lung cancer and pancreatic cancer. The FDA has accepted a Biologics License Application for Zenocutuzumab, indicating its potential as a groundbreaking treatment option. Merus's focus on bispecific antibodies exemplifies its strategy to create targeted therapies that can improve patient outcomes in complex cancer types.

Netherlands

Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have similar features as conventional monoclonal antibodies, such as long half-life and low immunogenicity.

Cancer

Urogenital Diseases

Merus

Non-small cell lung carcinoma

Pancreatic cancer

Solid tumor/s

MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that targets the HER3 pathway. The bispecific antibody docks on HER2, abundantly expressed on tumor cells, and subsequently efficiently blocks heregulin-stimulated growth of tumor cells by binding to HER3. MCLA-128 is designed to overcome the inherent and acquired resistance of tumor cells to HER2-targeted therapies using two mechanisms: 1) blocking growth and survival pathways to stop tumor expansion and 2) recruitment and enhancement of immune effector cells to eliminate the tumor.

BIZENGRI® (zenocutuzumab-zbco)

Head and neck squamous cell carcinoma

MCLA-158 is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics®&nbsp;for the treatment of solid tumors, including the potential treatment of colorectal cancer, that binds to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptor (EGFR). MCLA-158 is designed to use two different mechanisms of action. The first blocks growth and survival pathways in cancer stem cells. The second involves the recruitment and enhancement of immune effector cells to directly kill cancer stem cells that persist in solid tumors and cause relapse and metastasis.

Petosemtamab  (MCLA-158) +/- Keytruda (pembrolizumab)

Metastatic colorectal cancer

Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

Petosemtamab  (MCLA-158) (Lgr5 x EGFR Biclonics®) in comb w/ SoC

Petosemtamab (MCLA-158) (Lgr5 x EGFR Biclonics®)

MCLA-145 is a Biclonics® T-cell agonist discovered through an unbiased functional screening of multiple immunomodulatory target combinations. MCLA-145 binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the ability to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population

MCLA-145 (CD137 x PD-L1 Biclonics®) + Keytruda

MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced &nbsp;Biclonics® that is designed to inhibit the EGFR and c-MET signaling &nbsp;pathways in solid tumors. Preclinical data have shown that MCLA-129 can &nbsp;effectively treat TKI-resistant non-small cell lung cancer (NSCLC) in &nbsp;xenograft models of cancer. MCLA-129 is designed to have two &nbsp;complementary mechanisms of action: blocking growth and survival &nbsp;pathways to stop tumor expansion and recruitment and enhancement of &nbsp;immune effector cells to eliminate the tumor.

Merus

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