PDS Biotechnology and Merck established a collaboration to carry out a Phase II study evaluating PDS’ lead Versamune® immunotherapy candidate PDS0101 in combination with Merck’s anti-programmed cell death protein 1 (PD-1) monoclonal antibody therapy Keytruda® (pembrolizumab) in patients with recurrent or metastastic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after platinum-based chemotherapy has failed. No further details were disclosed.

PDS' announcement of the agreement with Merck comes just days after FDA placed clinical holds on three completely unrelated studies evaluating Keytruda in combination with Celgene’s Revlimid® (lenalidomide) and Pomalyst® (pomalidomide) against multiple myeloma. Keytruda was granted accelerated FDA approval in August 2016 as monotherapy for treating patients with recurrent or metastatic head and neck squamous cell carcinoma who have progressed on or after platinum-containing chemotherapy.

PDS0101 is in Phase II development in patients with pre-anal and cervical cancer, advanced localized cervical cancer, advanced localized head and neck cancer, and recurrent metastatic head and neck cancer. “This collaboration is supported by our recent Phase IIa human clinical data demonstrating that PDS0101 uniquely combined induction of high levels of active tumor-targeting T cells with an excellent safety profile,” commented PDS’ CEO Frank Bedu-Addo, Ph.D. “If PDS0101's strong human immunological responses and superior safety profile are confirmed by demonstration of clinical benefit for HPV-cancer patients in multiple upcoming Phase IIb trials, including this important alliance with Merck in combination with a checkpoint inhibitor, PDS will be uniquely positioned to meaningfully impact clinical outcomes across a wide range of patients with HPV-related cancers.”

PDS is exploiting its Versamune platform to develop subcutaneously administered cancer immunotherapies and T-cell vaccines for infectious diseases. The technology is designed to deliver tumor antigens directly to the immune system and stimulate the generation of tumor-killing T cells. The firm says the Versamune nanoparticle technology also eliminates the need for antigen encapsulation and enables a simplified manufacturing process using standard liposome manufacturing techniques.

In February last year, the firm signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the co-development through Phase II trials of a number of Versamune-based immunotherapies targeting prostate, breast, and HPV-related cancer

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