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.

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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.

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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.

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