The trial will investigate the safety and efficacy of a combo treatment of PDS’ product PDS0101 and Merck’s Keytruda (pembrolizumab). The combination therapy will be tested in patients with recurrent or metastatic head and neck cancer and high risk of human papillomavirus-16 (HPV16) infection, who failed prior treatment with platinum-based chemotherapy.
“This collaboration is supported by our recent Phase [2a] human clinical data demonstrating that PDS0101 uniquely combined induction of high levels of active tumor-targeting T-cells with an excellent safety profile,” Frank Bedu-Addo, PDS’s CEO, said in a news release.
Merck’s Keytruda is an antibody that inhibits the interaction between a protein called PD-1, present on the surface of the T-cells, and its ligands, PD-L1 and PD-L2. By blocking this interaction, Keytruda promotes the activation of T-cells, triggering an immune response in the body. Keytruda has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of a range of advanced cancers.
The experimental product PDS0101 is a combination of PDS’ Versamune platform, which was designed to promote the activation of the immune system and help T-cells recognize and attack cancer cells, and harmless peptides from the HPV virus that are known to trigger cancer development. By presenting these peptides to T-cells, PDS0101 boosts the action of the immune system against cancer. The Versamune synthetic T-cell activating nanoparticle platform is currently under investigation in human clinical trials.
PDS plans to launch several Phase 2b clinical trials to test PDS0101 in patients with HPV-advanced cancer and HPV pre-cancer.
“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 [2b] 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,” Bedu-Addo added.