On Oct. 03, 2019, PDS Biotechnology Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multi-functional immunotherapeutic products, reported a modification of the clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and Canada) to evaluate the combination of PDS’s lead Versamune-based immunotherapy, PDS0101, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II clinical trial (Press release, PDS Biotechnology, OCT 3, 2019, View Source [SID1234583939]). The planned clinical trial will now evaluate the efficacy and safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection and is expected to be initiated in the first quarter of 2020.
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The modification to the clinical trial design now allowing evaluation of PDS0101 in combination with KEYTRUDA as first-line treatment comes as a result of Merck’s recent approval by the FDA on June 10, 2019 for KEYTRUDA as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with platinum and fluorouracil (FU) for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.
"We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients," said Dr. Lauren V. Wood, Chief Medical Officer of PDS." The recently updated clinical outcome findings of the PDS0101 phase 1 human clinical trial demonstrate unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression/ elimination of pre-cancerous lesions) in the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses (PDS press release September 19, 2019). Preclinical data demonstrating the novel multi-functional mechanism of action of the Versamune platform technology and the resulting superior T-cell induction and unique regression of advanced tumors were published in the June 2019 issue of the Journal of Immunology.
PDS Biotechnology’s lead product candidate, PDS0101 (Versamune-HPV) is a proprietary clinical stage immunotherapeutic administered by subcutaneous injection being developed to treat HPV-associated cancers. These include cancers such as head and neck cancers and anal cancers, both of which are widely reported to be increasing in frequency over the last decade, and cervical cancer.
Details of the collaboration were not disclosed.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Versamune is a registered trademark of PDS Biotechnology Corporation, Berkeley Heights, NJ, USA.