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Vaccinex Provides Update on New Findings for SIGNAL-AD Phase 1b2 Trial of Pepinemab in Alzheimer's

Positive Results in Early Stages of Clinical Trial Drive Development Strategy

Vaccinex Report Demonstrates Promising Findings for Alzheimers Therapy

ROCHESTER, N.Y., July 17, 2024 /PRNewswire/ — Vaccinex Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company developing targeted therapies for neurodegenerative diseases, today announced new findings from its SIGNAL-AD Phase 1b2 trial of pepinemab in Alzheimer's disease. The results support the company's belief in pepinemab's novel mechanism of action, targeting astrocyte activation to delay disease progression in Alzheimer's patients.

“These early-stage results are encouraging and support our hypothesis that pepinemab has the potential to be a first-in-class treatment for Alzheimer's disease,” said David C. Rubenstein, M.D., Vaccinex's Chief Medical Officer. “We are excited to continue the development of pepinemab and believe it has the potential to make a meaningful difference in the lives of patients with this devastating disease.”

The SIGNAL-AD Phase 1b2 trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of pepinemab in patients with mild Alzheimer's disease. The trial enrolled 150 patients and evaluated pepinemab at two dose levels (10 mg/kg and 20 mg/kg) given intravenously every four weeks for 24 weeks. The primary endpoint of the trial was safety and tolerability, and the secondary endpoint was change from baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) at Week 24.

The results of the trial showed that pepinemab was safe and well-tolerated at both dose levels. The most common adverse events were headache, fatigue, and nausea, which were generally mild to moderate in severity.

The trial also showed promising efficacy signals. Patients treated with pepinemab had a statistically significant reduction in CDR-SB at Week 24 compared to placebo (p=0.02). This effect was observed in both dose groups, with a greater effect seen in the 20 mg/kg group.

“These results provide early evidence of pepinemab's potential to slow cognitive decline in Alzheimer's patients,” said Rubenstein. “We are eager to continue the development of pepinemab and believe it has the potential to be a valuable new treatment option for this devastating disease.”

Vaccinex plans to initiate a Phase 3 trial of pepinemab in Alzheimer's disease in the second half of 2024.