ROCHESTER, N.Y., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and nuerodegenerative diseases, today announced that it presented the scientific rationale and design of its recently announced Phase 1 study of pepinemab (VX15/2503) for Alzheimer’s Disease (AD) in a podium presentation on Saturday, December 7 at the 12th Clinical Trials on Alzheimer's Disease Conference in San Diego, USA. The CTAD Conference is a premier annual Alzheimer’s Disease event.
Common Pathways in Neurodegenerative Diseases
Building on clinical data from Cohort A of its ongoing, potentially pivotal, phase 2/3 SIGNAL study in Huntington’s Disease (HD), Vaccinex described similarities in pathogenic processes in HD and AD, two slowly progressive neuroinflammatory and neurodegenerative diseases that are associated with formation of abnormal protein aggregates in the brain.
Although the initiating events differ -- in HD it is a dominant mutation in the Huntingtin gene, and in AD an imbalance in biochemical pathways -- both appear to result in activation of inflammatory cells in the brain. The Vaccinex antibody, pepinemab, is believed to target this process by preventing transformation of brain glial cells from their normal supportive activities to inflammation.
The decline in brain metabolic activity as detected by FDG-PET may be a manifestation of this inflammatory process in both HD and AD. Multiple studies have previously shown that the decline in FDG-PET signal in AD correlates with cognitive decline. Vaccinex determined in Cohort A of the SIGNAL study that treatment with its anti-semaphorin 4D (SEMA4D) antibody, pepinemab, prevents decline of the FDG-PET signal. This is believed to be the first intervention to demonstrate an effect of this magnitude on FDG-PET signal in a neurodegenerative disease.
In further support of the parallel mechanisms in HD and AD, Vaccinex has now demonstrated in pre-clinical studies that the pepinemab target molecule, SEMA4D, is upregulated on neurons during disease progression in both AD and HD. Brain astrocytes express high levels of receptors for SEMA4D, and blocking binding of SEMA4D to these receptors may prevent inflammatory activation.
Awards to Vaccinex
The relevance of this ground-breaking work to AD has been recognized by two awards from the Alzheimer’s Association and from the Alzheimer’s Drug Discovery Foundation in support of this new phase 1, randomized, placebo-controlled, multi-center, dose finding study in 60 subjects with early AD, including mild cognitive impairment.
Dr. Maurice Zauderer, President and CEO of Vaccinex, commented, “This expansion of Vaccinex’s clinical development programs in neurodegenerative diseases underscores the importance of neurology as a driver of future growth for the company. Investors will be aware of Vaccinex’s novel immunotherapy program for cancer, highlighted in the recent announcement of promising interim data in NSCLC. We are pleased, therefore, to have this opportunity to focus attention on our equally innovative and important programs in HD and AD. We anticipate with excitement topline data in Q4 2020 from the potentially pivotal SIGNAL study in HD!”
The CTAD 2019 podium presentation is available for review on the Presentations page in the Investors section of the Company’s website, www.vaccinex.com.
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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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 the biological activities associated with antibody blockade of SEMA4D promote immune cell infiltration into tumors and prevention of 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 and Alzheimer’s disease.
About Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation
The Alzheimer's Association is committed to accelerating the global effort to eliminate Alzheimer's through new treatments, preventions and, ultimately, a cure. The Alzheimer’s Drug Discovery Foundation (ADDF) catalyzes and funds drug discovery and drug development for Alzheimer's disease and related disorders. This award was funded by the Alzheimer’s Drug Discovery Foundation through the Diagnostics Accelerator initiative.
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 13, 2019 and subsequent filings with the SEC.
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