Company Has Reassured Nasdaq of Actions It Plans to Take to Meet Minimum Bid Price Requirement
Randomized Phase 2 Study in Alzheimer’s Disease on Schedule to Complete Treatment in June 2024
ROCHESTER, N.Y., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease and cancer, previously reported that on October 10, 2023 it was advised by Nasdaq that the Company was no longer in compliance with Nasdaq’s minimum bid price requirement and that Nasdaq could move to suspend trading of the common stock and to delist the Company’s securities unless the company appealed Nasdaq’s determination. The Company appealed that decision and has been granted an exception until March 4, 2024 to address this issue. Subject to fulfilling its commitments to Nasdaq, it is expected that Vaccinex shares will continue to be listed on the Nasdaq Capital Market throughout this time and subsequently if compliance is restored.
Vaccinex continues to advance its key programs with particular focus on a potential near-term catalyst, the randomized phase 2 trial of its pepinemab antibody to counter neuroinflammation in Alzheimer’s disease (AD). The last patient in this trial is expected to complete the planned 12-months of treatment by early June 2024. Key endpoints include brain metabolic activity, a recognized biomarker of clinical progression in AD, as well as treatment effects on cognition employing several validated, clinically meaningful Alzheimer’s cognitive scales.
Investors will recall that Vaccinex has previously completed a randomized phase 2 study in Huntington’s disease (HD) in which it was demonstrated that pepinemab treatment significantly reduced characteristic decline in brain metabolic activity as measured by FDG-PET imaging and also reduced or prevented cognitive decline. There are numerous physiological parallels between neurodegenerative processes in Alzheimer’s and Huntington’s disease. A key common feature is the contribution of reactive astrocytes (astrogliosis) to brain inflammation and damage. Vaccinex scientists have demonstrated that the stress of disease in both AD and HD leads to upregulation of SEMA4D in neurons that can trigger astrogliosis resulting in a loss of normal supportive physiological functions such as brain metabolic activity and a gain of inflammatory activity marked by release of glial fibrillary acidic protein (GFAP) into the blood. Importantly, treatment with pepinemab in HD patients was shown to reverse disease associated changes in these two biomarkers, which we believe is evidence that pepinemab prevents astrocyte activation. Elevated plasma GFAP levels have also been reported to correlate with Aβ amyloid deposits in brain of patients with AD and to be associated with higher risk of dementia and faster rates of cognitive decline. We believe that these findings portend a potentially favorable clinical outcome for pepinemab treatment in AD.
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and of innate immune cells that regulate immune responses. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.
About Vaccinex Inc.
Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents immune infiltration into tumors. In neurodegenerative diseases, pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study, supported by funding from Gateway Discovery Foundation, in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma.
Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.
BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA and Pfizer.
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 ability to regain compliance with the minimum bid price standard, the continued listing of our common stock on the Nasdaq Capital Market, 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®, expectations with respect to the collaboration of Merck, expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial, the potential to initiate a Phase 3 trial in HD and any impact from ongoing FDA discussions, the expected timeline for disclosure of trial results at scientific conferences or through publications, and other statements identified by words such as “believes,” “being,” “may,” “will,” “appears,” “expect,” “continue,” “estimate,” “ongoing,” “potential,” “prevents,” “suggest”, 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, our ability to regain compliance with the minimum bid price standard, the possible delisting of our common stock from Nasdaq if we are unable to comply with Nasdaq listing standards, whether Nasdaq will confirm that we have regained compliance with the minimum bid price standard or otherwise grant further relief from delisting, 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, 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.
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.