Vaccinex, Inc., (Nasdaq: VCNX, Vaccinex, the Company), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today reported positive interim safety data in the Phase Ib safety run-in segment of the KEYNOTE B84 combination study of Keytruda (Merck, NYSE: MRK, known as MSD outside of the United States and Canada) and pepinemab (Vaccinex) in patients with advanced, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The Phase 2 segment of the study is now expected to begin enrollment and is expected to accelerate patient accrual.
The Phase Ib safety run-in segment of the trial (NCT04815720) was intended to evaluate the safety and tolerability of pepinemab (20 mg/kg) in combination with Keytruda (Mercks anti-PD-1 therapy, pembrolizumab, 200 mg Q3W/every three weeks) to determine a recommended Phase 2 dose (RP2D) for the dose expansion phase of the study enrolling patients with R/M HNSCC. The interim safety analysis was completed by the Data Safety Monitoring Board and signals initiation of the Phase 2 expansion segment.
We are very pleased that the interim KEYNOTE B84 safety data indicated that the combination of pepinemab and Keytruda appears to be well tolerated, stated Maurice Zauderer, Ph.D., President and Chief Executive Officer. Vaccinex hopes that the combination of pepinemab and an anti-PD-1 therapy for the treatment of advanced R/M HSNCC may result in improved patient benefits. There is strong rationale for development in HNSCC because these tumors express very high levels of SEMA4D and we believe that preclinical data indicated that this contributes to disease pathology. We look forward to progressing with the recruitment of the Phase 2 segment of the trial.