On September 17, 2020 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a novel approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada), through a subsidiary, to evaluate the combination of Vaccinex’s investigational SEMA4D inhibitor, pepinemab, and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in the treatment of patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Vaccinex, SEP 17, 2020, View Source [SID1234565296]).
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"We are pleased to be working with Merck to evaluate the potential of pepinemab in combination with KEYTRUDA to further improve the efficacy of cancer immunotherapy," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. "Several prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. SEMA4D is highly expressed in HNSCC and is believed to promote correspondingly high levels of myeloid derived suppressor cells. This collaboration provides an opportunity to evaluate this innovative approach in combination with anti-PD-1 therapy."
The planned clinical collaboration with pepinemab and pembrolizumab will consist of a dose escalation phase followed by an expansion phase that will enroll up to 65 HNSCC patients allocated to different levels of combined positive score (CPS) of PD-L1 expression. CPS is a biomarker associated with benefit in response to immunotherapy, and a major goal of this study is to determine whether combination therapy can improve response in these populations. Key endpoints of the study include objective response, progression free survival and overall survival.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Pepinemab
Pepinemab, also known as VX15/2503, is a humanized monoclonal antibody that binds and blocks the activity of semaphorin 4D (SEMA4D) which is an extracellular signaling molecule that regulates the migration and function of immune and inflammatory cells. Preclinical studies have demonstrated that the biological activities associated with antibody blockade of SEMA4D promote immune cell infiltration into tumors and prevent neurological damage in neuroinflammatory and neurodegenerative disease models. Vaccinex is focused on the development of pepinemab for the treatment of cancer and neurodegenerative diseases including Huntington’s disease. Pepinemab is an investigational new drug that has not yet been approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities for any indication.