PDS Biotechnology has modified a clinical trial collaboration agreement with a Merck subsidiary to study its immunotherapy, PDS0101, in combination with Merck’s Keytruda for the treatment of head and neck cancer.
Additional details of the alliance have not been disclosed.
The Phase II trial is scheduled to begin in the first quarter of next year and is designed to assess the safety and efficacy of the combination as first-line therapy.
In addition to recurrent or metastatic head and neck cancer patients, the trial will enrol subjects with high-risk human papillomavirus-16 (HPV16) infection.
The modification to study the combination as first-line therapy is made possible by the FDA’s authorisation in June for the use of Merck’s Keytruda as a monotherapy for PD-L1-expressing tumours.
The FDA approval also covers a Keytruda combination with platinum and fluorouracil (FU) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma.
Based on PDS Biotechnology’s Versamune platform, PDS0101 contains HPV16 E6 and E7 peptide antigens to trigger cytolytic T-cell responses against HPV.
It is intended for subcutaneous administration to treat HPV-associated cancers, including head and neck cancers, anal cancers and cervical cancer.
Data from Phase I clinical trial showed that PDS0101 causes in-vivo systemic induction of high levels of HPV-specific killer T-cells that induce granzyme-b.
Trial results reported no dose limiting toxicities across all study doses.
During preclinical studies, Versamune platform technology is reported to have demonstrated a multi-functional mechanism of action, enhanced T-cell induction and regression of advanced tumours.