Presentation highlighted the potential of the company’s lead candidate, the anti-SEMA4D antibody pepinemab, to regulate glial cell activation and neurodegeneration in Alzheimer’s and Huntington’s disease
ROCHESTER, N.Y., April 07, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and neurodegenerative diseases, today announced that the company’s vice president of preclinical research, Elizabeth Evans, Ph.D, delivered a virtual presentation at the Alzheimer’s and Parkinson’s Therapies AAT-AD/PD™ Focus Meeting 2020, which was held from April 2-5.
The presentation, entitled, “Regulation of Glial Cell Activation and Neurodegeneration by Anti-Semaphorin 4D Antibody Pepinemab, Potential Treatment for Alzheimer’s and Huntington’s Disease,” summarizes compelling findings from 19 patients enrolled in the company’s ongoing SIGNAL Phase 2 trial of pepinemab for the treatment of Huntington’s disease.
“Our presentation at this important meeting underscores the potential of pepinemab as a new therapeutic option for neurodegenerative diseases, notably Huntington’s and Alzheimer’s, two progressive and debilitating conditions with no effective treatments or known cures,” said Maurice Zauderer, President & CEO, Vaccinex, Inc. “The data, from Cohort A of our SIGNAL trial, suggest pepinemab has the potential to address both the brain pathology and cognitive and motor symptoms characteristic of Huntington’s disease. The trial is ongoing, and we’re looking forward to building on these findings with data from Cohort B of the study.”
“We believe the ability of pepinemab to block SEMA-4D overexpression also holds great promise in Alzheimer’s disease, a view that is shared by the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Association, two leading advocacy groups who collectively awarded us more than $3.7 million in development grants. We are eager to formally explore pepinemab in Alzheimer’s patients, and intend to initiate a clinical trial in this indication this year,” Dr. Zauderer concluded.
The presentation described the results of 19 Huntington’s disease patients who were enrolled in cohort A of the company’s SIGNAL trial. The primary clinical endpoint was standard uptake value (SUV) of fluorodeoxyglucose as measured by positron emission tomography (FDG-PET), an established and clinically relevant biomarker in neurodegenerative diseases. In cohort A, a striking increase in FDG-PET SUVR in multiple cortical regions of interest was observed in subjects treated with pepinemab for six months (n=11) compared to placebo control (n=8). The estimated difference between the mean FDG-PET Index was 0.78 +/- 0.31 (95% CI, 0.11 to 1.40; p=0.025). In addition, preservation of brain matter (reduced atrophy) and improvement in multiple motor and cognitive assessments were also observed.
Cohort B of the SIGNAL study is ongoing, with 265 Huntington’s disease patients (both early manifest subjects and late prodromal subjects) targeted for enrollment. As of March 30, 2020, 200 of the 265 patients have completed the planned 18 months of treatment and a safety follow-up, and 16 have withdrawn. Of the remaining 43 subjects, 38 have completed 16 of the 18 monthly visits specified in the trial protocol. The company is working with clinical investigators and sites to safely accelerate completion of remaining visits and assessments and will provide further updates as warranted. Cohort B is a double-blind, placebo-controlled study with multiple endpoints.
Pepinemab has been granted the Orphan Drug and Fast Track designations by the FDA’s Division of Neurology Products.
Pepinemab, also known as VX15/2503, is a humanized monoclonal antibody that binds and blocks the signaling 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 antibody blockade of SEMA4D promotes tumoricidal immune activity in tumors and prevents brain 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 and Alzheimer’s disease.
About Vaccinex, Inc.
Vaccinex, Inc. is a clinical-stage immunotherapy company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, with currently active clinical trials in non-small cell lung cancer and Huntington’s disease. Vaccinex is based in Rochester, New York.
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Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the Huntington’s and Alzheimer’s disease clinical trials, the use of pepinemab, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab (VX15/2503), and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in our Form 10-K dated March 9, 2020 and subsequent filings with the SEC.
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Cait Williamson, Ph.D.
LifeSci Communications, LLC
Source: Vaccinex, Inc.