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Topline data anticipated in mid-2024
SIGNAL-AD builds on promising data from the Phase 2 SIGNAL Study in Huntington’s Disease
The randomized, double-blinded, placebo-controlled Phase 1b/2 SIGNAL-AD study was designed to evaluate the safety, tolerability and effects on cognition and brain metabolism of the SEMA4D inhibitor, pepinemab. The one-year study enrolled 40 patients with mild Alzheimer’s dementia. The SIGNAL-AD study was designed to build on the exciting data obtained in the Phase 2 SIGNAL study of pepinemab in Huntington’s disease (HD), another neurodegenerative disease with many similarities in pathology to AD. Data from the SIGNAL-HD study were published in Nature Medicine (2022).
“Completing enrollment in the SIGNAL-AD study is a major accomplishment for
“Multiple prior clinical studies in AD have shown that, as in HD, a decline in brain metabolic activity correlates with disease progression. Pepinemab is the only clinical intervention to date that has been shown to reduce or prevent decline in brain metabolic activity while also appearing to slow or prevent cognitive decline. Based on the clinical data and favorable profile from the SIGNAL study in HD, we are hopeful that treatment with pepinemab can open the door to a safe and effective, disease modifying treatment option for patients with Alzheimer’s Disease. Disease-related stress, such as is induced by accumulation of toxic aggregates of beta-amyloid in AD and mutant huntingtin protein in HD, activate inflammatory cells in brain that inhibit normal healthy functions of neurons and aggravate neurodegeneration. We believe that blocking neuroinflammatory signals with pepinemab represents a novel approach to treating NDD with the potential to complement independent amyloid-lowering strategies,” continued
About the SIGNAL-AD Study
The SIGNAL-AD study was designed to evaluate the treatment of pepinemab in patients with mild AD. The randomized, double-blinded, placebo-controlled study enrolled 40 patients at 16 sites in the
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in inflammatory reactions in the brain as well as in tumor immune evasion. Data show that by preventing deleterious inflammatory gliosis during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the function and health of neurons in the brain. Additional preclinical and clinical data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in neurodegenerative disease and oncology. Pepinemab has been administered to more than 400 patients and appears to have a favorable safety and tolerability profile.
About Vaccinex Inc.
Forward Looking Statements
To the extent that statements contained in this presentation 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 results and timing of the KEYNOTE-B84 clinical trial, planned interim analysis, the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications, the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®, the expected timeline for publication and disclosure of trial results, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “suggest”, “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 the outcome of 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 studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, the possible delisting of our common stock from NASDAQ if we are unable to regain compliance with the NASDAQ listing standards, 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 the Company’s annual year-end Form 10-K and subsequent filings with the SEC.
Source: Vaccinex, Inc.