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PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA® (pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers Symposium
Preliminary safety data has shown that PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of recurrent or
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Preliminary safety data has shown that PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity FLORHAM PARK, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology, today announced the presentation of preliminary safety data. The data are based on a total of 18 checkpoint inhibitor (CPI) naïve patients from the Company’s ongoing VERSATILE-002 Phase 2 study. The study is being conducted in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126). The data from the study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium. The Phase 2 trial studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The trial is designed to treat both CPI naïve and refractory patients and will assess the primary efficacy endpoint, as well as partial response per RECIST 1.1. The Company previously announced that it had achieved its preliminary efficacy milestone in the CPI naive arm earlier this month. Patients in the trial are treated with KEYTRUDA® 200 mg intravenously every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA® on cycles of 1-4 and again at cycle 12. An initial safety cohort was assessed during cycle 1 and 21 days following for dose-limiting toxicity, and thereafter for safety and tolerability of the combination. Highlights from the PDS Biotech’s presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium regarding the preliminary results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA® (range 1-13). In addition, no t...