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Pepinemab (VX15), an experimental Vaccinex drug previously shown to prevent reduced brain glucose transport in Huntington’s disease, will be tested for similar effects in Alzheimer’s disease
ROCHESTER, N.Y., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel antibody therapies in neurodegenerative diseases and cancer, today announced that it received notice of a $750,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud Program to evaluate its lead drug candidate, pepinemab (VX15), in Alzheimer’s Disease (AD).
Eric Siemers, MD, formerly senior medical director of the Alzheimer's Disease Global Development Program at Eli Lilly and Company, will serve as Senior Medical Director of this 60 subject, randomized, placebo-controlled, multi-center clinical study which is expected to start enrolling in 2Q 2020. Top-line data is anticipated late 2021/early 2022.
Vaccinex’s plan for this study is based on evidence from Cohort A of its ongoing “SIGNAL” clinical trial in Huntington’s disease (HD) that showed treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying HD disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease. In particular, previous studies in AD have shown that decline in glucose transport correlates with cognitive decline and, more recently, that FDG-PET is a superior indicator of cognitive performance compared to Aβ amyloid-PET in AD. Based on supporting preclinical data, Vaccinex believes that FDG-PET is a biomarker of underlying pathogenic transformation of astrocytes from normal function to an inflammatory state in which, among other important changes, they abandon their normal role in glucose transport. The important pathogenic role of inflammatory transformation of glial cells such as astrocytes in neurodegenerative disease progression has become the focus of considerable attention in AD research in recent years.
“We are very pleased to partner with the Alzheimer’s Association,” said Maurice Zauderer, President & CEO, Vaccinex, Inc. “This will be the first clinical trial of pepinemab as a potential treatment of Alzheimer’s disease, and it will complement our larger ongoing SIGNAL study which seeks to evaluate the clinical benefit of pepinemab in HD. If we determine that pepinemab provides clinical benefit in HD and has similar glucose uptake biomarker activity in AD, which together with safety is the main goal of the present SIGNAL study, then we believe this would be a very compelling basis to investigate possible clinical benefit of pepinemab in a larger subsequent study in AD as well as potentially in other neurodegenerative and neuroinflammatory diseases.”
Dr. Siemers, the study’s Senior Medical Director and a distinguished neurologist, said, “While treatment options exist to address many of the symptoms of Alzheimer’s disease, there is as yet no effective treatment to slow or prevent disease progression. Pepinemab’s unique mechanism of action has demonstrated encouraging effects on FDG-PET signal in Huntington’s disease patients, and these results provide a strong rationale to expand treatment to Alzheimer’s disease. I am eager to work with the Vaccinex team to initiate this development program as quickly as possible.”
About Alzheimer’s Association
The Alzheimer's Association is committed to accelerating the global effort to eliminate Alzheimer's through new treatments, preventions and, ultimately, a cure.
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.
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 CLASSICAL-Lung clinical trial, the combination of pepinemab and avelumab, and other statements identified by words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “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 13, 2019 and subsequent filings with the SEC.
LifeSci Advisors, LLC