Clinical-stage oncology company Merus NV (MRUS:NASDAQ), which is focused on the development of full-length multispecific antibodies (Biclonics® and Triclonics®) engineered to strengthen anti-cancer effects against the complex mechanisms that drive cancer, today presented "clinical data on MCLA-158, including clinical responses observed in advanced head and neck squamous cell carcinoma (HNSCC) and preclinical data on zenocutuzumab (Zeno) at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics."
The company's Chief Medical Officer Dr. Andrew Joe stated, "We are encouraged by the early evidence of clinical activity of MCLA-158 in patients with advanced, previously treated HNSCC, further validating the potential of our Biclonics® platform. With Zeno, our preclinical research continues to reinforce the mechanisms by which Zeno is capable of potently inhibiting the growth of NRG1 fusion cancers."
Merus advised that the clinical data for MCLA-158 (petosemtamab) was collected during its ongoing Phase 1 dose expansion study designed to evaluate anti-tumor activity of MCLA-158 when used as a monotherapy in advanced HNSCC. The firm listed that the primary objectives of the study are to measure the efficacy, safety and tolerance of MCLA-158.
The company stated that a total of 10 patients between the ages of 50 and 70 with advanced HNSCC were enrolled in the clinical trial. The median age of the participants was 65 and each had previously been treated with a median of 2 lines of therapy.
The firm presented clinical data for the first 7 of the 10 patients who enrolled in the trial for a period of at least 8 weeks. The remaining three individuals in the cohort had not yet met the 8-week cut-off measure and therefore that data was not included in the interim analysis.
The company stated that in the study, three of the first seven patients evaluated had achieved partial responses and one person reportedly achieved a complete response after the data cutoff date. The firm pointed out that tumor shrinkage and partial responses was evident in all seven of the trial participants with advanced head and neck squamous cell carcinoma (HNSCC) who were given MCLA-158. The firm added that it intends to release further updates from the ongoing study in 2022.
The company also took the opportunity to discuss its observations and findings in preclinical studies of zenocutuzumab (Zeno). Merus highlighted that "the bispecific HER2/HER3 antibody Zeno blocked cell growth 100-fold more potently than the bivalent HER3 antibody derived from Zeno, in an NRG1 driven growth assay."
Merus mentioned that as of the beginning of September 2021, it had treated over 80 patients with NRG1 fusion cancers with Zeno monotherapy in its Phase 1/2 eNRGy trial and Early Access Program.
The firm stated that "MCLA-158 (petosemtamab) is an ADCC-enhanced human IgG1 Biclonics® designed to bind to cancer stem cells (CSCs) expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptor (EGFR)." In preclinical models, MCLA-158 has displayed potential to block growth and survival pathways in cancer initiating cells. Another positive observation that it also enhances and boosts immune effector cells to directly kill cancer initiating cells that typically persist in solid tumors and often are the cause of a relapse and metastasis.
The company explained that "Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+)." Zeno is designed specifically to bind to HER2 and potently block interaction of HER3 with ligand NRG1 or NRG1-fusion proteins.
Merus NV is a clinical-stage oncology company based in the Netherlands that is engaged in creating and developing innovative, targeted treatments to address unmet medical needs in various forms of cancer. The firm is developing full-length human IgG bispecific and trispecific antibody therapeutics called Multiclonics® that possess many of the same characteristics as conventional human monoclonal antibodies, including long half-life and low immunogenicity. The company's Multiclonics® therapeutics work by binding to multiple targets and are designed to incorporate advantageous features that provide anti-cancer effects against known but complex mechanisms that drive cancer formation and growth.
The company listed on its website that zenocutuzumab (Zeno) is its most advanced cancer drug candidate. Zeno is described as "a Biclonics® antibody with a HER2/HER3 target combination directed at neuregulin 1 (NRG1) fusions, a rare and powerful driver of cancer cell growth." The firm stated that in early clinical activity Zeno has shown strong potential for treatment of patients with lung, pancreatic and other solid tumors that harbor NRG1 fusions.
Merus started the day with a market cap of around $770.0 million with approximately 38.5 million shares outstanding and a short interest of about 5.6%. MRUS shares opened nearly 46% higher today at $29.15 (+$9.15, +45.75%) over yesterday's $20.00 closing price. The stock has traded today between $24.78 and $29.7699 per share and closed for trading at $27.49 (+$7.49, +37.45%).
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