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PDS Biotech Achieves Safety Requirement Milestone For the First 12 Patients in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Advanced Head and Neck Cancer
No dose limiting toxicities observed in initial group of 12 patients FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"No dose limiting toxicities observed in initial group of 12 patients\nFLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer achieved its preliminary safety benchmark in its first 12 patients. Enrollment in the trial, which studies PDS0101 administered in combination with KEYTRUDA® (pembrolizumab), will now continue to full enrollment of the first stage of the study, which will assess efficacy in 17 checkpoint inhibitor (CPI) naïve patients and in an additional group of 21 patients who have also failed prior therapy with checkpoint inhibitors (CPI refractory). The trial is being conducted in collaboration with Merck & Co. VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory). As specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) among at least four of the first 17 patients in the CPI naïve arm and at least 2 patients in the first 21 patients of the CPI refractory arm will trigger advancement to the second stage of the study and full enrollment of the planned 95 patients. “The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence regarding the safety of PDS0101. Treatment-related adverse events (TRAEs) generally appear to be limited to transient, manageable local injection site reactions,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “There is an enormous unmet medical need for more effective treatment of advanced head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to continuing to share data f...