On February 24, 2022 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, reported the presentation of preliminary safety data (Press release, PDS Biotechnology, FEB 24, 2022, View Source [SID1234609031]). 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.

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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 treatment-related grade 3 or higher toxicities were reported.

Preliminary safety data has shown that PDS0101 in combination with KEYTRUDA 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 in the first 18 patients evaluated on the study. Accrual in this study has progressed to Stage 2 for the CPI naïve cohort and is ongoing in Stage 1 for the CPI refractory cohort. The full data set can be found under abstract number 157 at the virtual poster library, here.

Receipt of preliminary results are not necessarily indicative of the final-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.

"We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA for patients with recurrent or metastatic HPV16-positive head and neck cancer," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune platform."

In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS Biotech is conducting another Phase 2 clinical study in both second-and third-line treatment for multiple advanced HPV-associated cancers with the National Cancer Institute (NCI) (NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV (NCT04580771), in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. In addition, the Company recently announced a fourth Phase 2 trial with Mayo Clinic to study PDS0101 with and without KEYTRUDA prior to surgery in locally advanced HPV-associated oropharyngeal cancer (NCT05232851).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.