Vaccinex, Inc. Presents New and Promising Phase 2 SIGNAL Trial Data in Plenary Session at European Huntington’s Disease Network Meeting
September 15, 2021 at 08:00 am EDT
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Vaccinex, Inc. announced that Maurice Zauderer, PhD, Chief Executive Officer, presented new and promising data from continued analysis of final results of the phase 2 SIGNAL Huntington’s Disease Trial at the European Huntington Disease Network Meeting, which was held September 9, 2021 to September 11, 2021. Plenary session and panel discussion: on September 10, 2021, Dr. Zauderer joined clinical leaders from Roche, Wave, Uniqure and Prilenia to discuss major lessons and continuing plans for clinical trials in Huntington’s disease (HD). Dr. Zauderer highlighted new data from the SIGNAL phase 2 trial believed to further support the cognitive benefit of treatment with the pepinemab antibody. People with HD regularly identify cognitive impairment as a major concern that significantly impacts their daily life. Dr. Zauderer also presented subgroup analysis suggesting that the greatest benefit from treatment was detected in patients with moderately advanced disease and discussed how these findings will impact the design of a planned pivotal phase 3 trial, for which the company is actively evaluating potential development partners. During the panel discussion that followed, Dr. Zauderer discussed how he believed the results of SIGNAL and other Vaccinex studies have advanced the company’s understanding of pathogenic mechanisms and help to lay a foundation for optimal timing of treatment and identifying rational combination therapies that may result in even greater efficacy in the future. SIGNAL was a phase 2, multi-center, randomized, double-blinded, placebo-controlled clinical trial in subjects with early manifest and late prodromal HD to assess safety, tolerability, pharmacokinetics, and efficacy of pepinemab. The study included 179 subjects with early manifest disease and 89 subjects diagnosed as late prodromal. Individuals were randomized 1:1 for monthly intravenous infusion with either 20 mg/kg pepinemab or placebo for at least 18 months. The study is now complete and a phase 3 study is being planned to expand on promising data pointing to cognitive benefits of treatment with pepinemab.
Vaccinex, Inc. is a clinical-stage biotechnology company. It discovers and develops targeted biotherapeutics to treat diseases with unmet medical needs, including cancer, neurodegenerative diseases and autoimmune disorders. Its platform technologies include SEMA4D antibody platform and ActivMAb antibody discovery platform. SEMA4D antibody platform is the application of its knowledge of SEMA4D biology to develop its lead product candidate pepinemab for the treatment of various diseases and conditions, including cancer and neuroinflammatory and neurodegenerative diseases. Pepinemab's mechanisms of action block the SEMA4D signal and activate innate physiological mechanisms to respond to tumors or tissue injury. ActivMAb antibody discovery platform is a human antibody discovery platform based on a method for expressing multipass membrane proteins, as well as large and diverse libraries of high affinity, full-length human monoclonal antibodies on the surface of mammalian pox viruses.