Vaccinex reports findings at medical conferences on Pepinemab

Vaccinex will report on novel findings for its lead product, pepinemab, with implications for treatment of Alzheimer’s and other slowly progressive neurodegenerative diseases and for cancer immunotherapy at two upcoming Medical Conferences. Results from phase 2 SIGNAL trial suggest pepinemab is the first therapeutic agent that appears to have the potential to prevent decline in brain metabolic activity and to slow or halt cognitive decline in Huntington’s disease. Encouraged by these findings, a separate, randomized, phase 1/2a study in AD is ongoing in which the last patient is anticipated to complete the planned 12-months of treatment in early June 2024. Pepinemab in combination with a checkpoint inhibitor is, the first treatment that has shown the potential to induce formation of lymphoid structures in tumors that promote efficient immune responses and are known to be associated with improved outcomes in head and neck cancer. Clinical results indicate an approximate doubling of objective responses and progression free survival relative to historical results with checkpoint monotherapy in patients with hard-to-treat tumors that express low levels of PD-L1. Alzheimer’s Disease: Vaccinex completed enrollment in the randomized, double-blind SIGNAL-AD phase 1/2a study for early AD in May 2023. The last patient is anticipated to complete the planned 12 months of treatment by early June 2024 at which time the database will be locked and results analyzed. Key endpoints include brain metabolic activity along with measures of cognition specific to AD. Clinical consensus is that Leqembi and donanemab provide a modest but real benefit to patients at a very early stage of disease. Common side effects associated with these drugs, however, include an inflammatory and hemorrhagic response in brain denoted as ARIA. “We believe that use of pepinemab to treat slowly progressive neurodegenerative diseases like AD has been substantially de-risked by results from our completed phase 2 study in HD,: the company said. Cancer: The Phase 2 KEYNOTE-B84 study evaluated Vaccinex’s pepinemab antibody in combination with Merck’s anti-PD-1 therapy, KEYTRUDA for immunotherapy of recurrent or metastatic head and neck squamous cell carcinoma. Results of a preplanned interim analysis of the first 36 patients treated in this study indicated that the Objective Response for the PD-L1 low population, CPS less than20, was 21.1% and median progression free survival was 5.79 months, which are approximately twice that of historical ORR and PFS for checkpoint monotherapy in this population. In contrast, in the CPS greater than or equal to20 subgroup, the ORR and PFS for combination therapy was similar to historical checkpoint monotherapy. The results indicate that treatment with pepinemab in combination with KEYTRUDA appears to induce formation of highly organized lymphoid aggregates in the tumor of patients who demonstrate disease control.