Vaccinex, Inc.

Neoadjuvant treatment with pepinemab appears to induce abundant, mature lymphoid structures that correlate with durable clinical benefit of immunotherapy in patients with metastatic melanoma. Pepinemab, Semaphorin 4D blocking immunotherapy, also appears to induce the formation of efficient lymphoid structures in “cold” tumors of patients with recurrent and metastatic head and neck cancer. April 21, 2025 -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present exciting new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies, corresponding with improved survival benefit in patients with melanoma and head and neck cancer at the 2025 Annual Meeting of American Association for Cancer Research (AACR) in Chicago on April 29, 2025. Elizabeth Evans, PhD, Senior VP Discovery and Translational Medicine, will present results of these studies in two presentations. AACR Conference Information: Date:Tuesday, April 29, 2025 Presentation title:Regulating dendritic cells to promote mature tertiary lymphoid structures and enhance anti-tumor immunity. Presentation #3975 Time:9-12 AM CDT/10 AM – 1 PM EDT. Session Title:The Tumor Immune Interplay as a Driver of Progression Presentation title:Neoadjuvant pepinemab enhances DC function associated with mature tertiary lymphoid structures and activity of immune checkpoint blockade in patients with metastatic melanoma. Presentation #6007 Time:2-5 PM CDT/ 3-6 PM EDT. Session Title:Therapeutic Antibodies, Including Engineered Antibodies 2 Access:Posters will be presented in-person on Tuesday, April 29 at McCormick Place Convention Center, Chicago, Illinois, and on AACR 2025 virtual meeting platform at 1:00 PM ET on Friday, April 25, 2025. Previously reported data from these two clinical studies suggest a crucial role of pepinemab to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses. New data will characterize clinical outcomes, biomarkers, and mechanisms of these interactions in patients treated with pepinemab in combination with immune checkpoint therapy. Boosting TLS within tumors is an area of growing excitement because the presence of TLS has been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. A limitation in the field has been identification of safe and effective therapies that can induce formation and harness the potential of TLS to enable durable benefit to patients. Pepinemab may represent a solution to this problem, as our data demonstrate the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative and PD-L1-low head and neck cancer, into hot immune centers by inducing robust and mature TLS. Neoadjuvant immunotherapy has emerged as a promising approach in the treatment of various cancers, showing improved immune and clinical benefit in the preoperative setting compared to standard post surgery adjuvant treatments. Despite these advances, many patients who initially benefit from antibodies that block inhibitory checkpoint molecules (e.g. PD-1, CTLA 4) will progress. More effective combination therapies are needed. Neoadjuvant treatment with pepinemab enhanced TLS maturity and correlated with longer recurrence-free survival when combined with immune checkpoint inhibitors in patients with metastatic melanoma. Evaluation of pepinemab in the neoadjuvant setting for patients with head and neck cancer is ongoing and will be reported at upcoming scientific meeting this Spring. Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications. 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 prevents infiltration and activation of immune cells in tumors and triggers damaging inflammation in neurodegenerative diseases. 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 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. We believe pepinemab has also given promising results as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data suggesting a slowing of cognitive decline in Huntington’s disease. 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, Darmstadt, Germany and Pfizer. The content above comes from the network. if any infringement, please contact us to modify.

Vaccinex’s lead asset is being evaluated in neurodegenerative and oncological indications. Image credit: Shutterstock/interstid. Despite reporting positive Phase II results for its lead candidate last year, Vaccinex will soon no longer be a publicly traded company after falling short of Nasdaq requirements. The US-based company will delist its shares of common stock from Nasdaq via a Form 25 it intends to submit to the Securities and Exchange Commission on or around the 17 March. Form 25s are used by public company to officially delist their securities from a stock exchange, with delisting becoming effective 10 days after the document is filed. Vaccinex, currently listed on Nasdaq under the ticker VCNX, had its common stock trading suspended in December 2024 following a hearings panel from Nasdaq amidst financial shortcomings. Nasdaq notified Vaccinex of delisting intentions after equity requirements for companies trading on the stock exchange were not met. Vaccinex went public in 2018, raising around $40m to advance its pipeline of neurodegenerative disease therapies. The initial public offering (IPO) was priced at $12 per share, though share prices have since plummeted – arriving at $3.82 by the start of December 2024. Vaccinex’s market cap is currently just shy of $2.5m. As with many early-stage companies, Vaccinex funnelled the majority of its resources into a lead candidate. The asset, called pepinemab, is an antibody being evaluated in neurogenerative diseases and cancer indications. As pepinemab advanced through studies, Vaccinex’s research and development expenses grew. As per its most recent quarterly results ending September 2024, Vaccinex was left with just $2.9m in cash. Vaccinex affirmed it “plans to continue to focus on development of its lead product, pepinemab, to treat Alzheimer’s disease and cancer through partnerships, grants and other financing avenues.” Pepinemab, previously called pepinemabin, has shown promise, producing positive topline results in a Phase Ib/II trial (NCT04381468) in patients with Alzheimer’s disease in July 2024. Vaccinex reported that its asset, given as a monotherapy, resulted in a statistically significant increase in FDG-PET signal in areas of the brain known to be affected by early disease progression. The drug was also investigated in Huntington’s disease, with similar Phase II safety profile and brain metabolic activity effects. Judging by lack of investor enthusiasm in the company, Vaccinex has found the pressures from already-marketed Alzheimer’s therapies hard to repel. Eisai and Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) dominate the landscape, winning approvals in the US in 2023 and 2024 respectively. Leqembi is forecast to see $5.3bn in global revenues by 2030, with Kisunla expected to generate $1.7bn by the same year, according to GlobalData’s Pharma Intelligence Centre. GlobalData is the parent company of Pharmaceutical Technology . Despite its delisting, Vaccinex will also continue to focus on pepinemab in oncology indications. The antibody is evaluated in combination with MSD’s Keytruda in the Phase Ib/II KEYNOTE-B84 study (NCT04815720) in recurrent or metastatic head and neck cancer (HNSCC). Vaccinex has also teamed up with Merck KGaA to test pepinemab in combo with Bavencio (avelumab) in a Phase Ib/II study in patients with metastatic pancreatic adenocarcinoma (PDAC).

ROCHESTER, N.Y., March 07, 2025 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (OTC: VCNX) (“Vaccinex” or the “Company”), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease by blocking astrogliosis and neuroinflammation through the inhibition of SEMA4D, today announced that it has notified the Nasdaq Stock Market (“Nasdaq”) of its decision to delist the Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), from Nasdaq. Trading in the Common Stock on Nasdaq has been suspended since December 18, 2024. Vaccinex intends to file a Form 25 with the Securities and Exchange Commission on or about March 17, 2025 to remove its Common Stock from listing on Nasdaq. The Company’s decision to delist follows its receipt of notice dated December 16, 2024, that the Nasdaq Hearings Panel had determined to delist the Company’s securities from Nasdaq, and the subsequent suspension of trading. Nasdaq would have otherwise filed a Form 25 in due course. The Company plans to continue to focus on development of its lead product, pepinemab, to treat Alzheimer’s disease and cancer through partnerships, grants and other financing avenues. 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 infiltration and activation of immune cells in tumors. Pepinemab was studied as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data in Huntington’s disease. Vaccinex believes pepinemab could also be an important contributor to combination therapy in AD. 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 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. 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, Darmstadt, Germany and Pfizer. About Pepinemab Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to have been well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications. 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 may be forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements identified by words such as “may,” “will,” “intends,” “plans,” “expects,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). These statements include, among others, those regarding the expected timing of the delisting from Nasdaq and expected benefits of delisting. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. 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 and the other risks and uncertainties described in Vaccinex’s most recent year-end Annual Report on Form 10-K and subsequent SEC filings. Investor Contact Elizabeth Evans, PhD Chief Operating Officer, Vaccinex, Inc. (585) 766-2033 eevans@vaccinex.com Source: Vaccinex, Inc.