PDS0101 is an investigational cancer vaccine with the potential to stimulate the immune system to fight cancer. It is being developed by PDS Biotechnology.

How PDS0101 works

PDS0101 uses the company’s Versamune platform, which is a targeted cancer immunotherapy platform designed to train the T-cells of the immune system to recognize cancer-causing proteins of the human papillomavirus-16 (HPV-16) and attack HPV-16-caused cancer cells.

The Versamune platform facilitates the entry of the cancer antigen into specialized cells of the immune system called antigen presenting cells (APC) that “present” the viral proteins to other cells of the immune system, namely killer and helper T-cells. It also reduces immune suppression in tumors resulting in a more efficient killing of tumor cells by T-cells. Finally, it induces other immune activators in the lymphatic system, leading to the expansion of T-cells that have been “primed” or “educated” to recognize these viral proteins.

PDS0101 in clinical trials

A Phase 1 study (NCT02065973) has been completed in people with cervical neoplasia infected with high-risk cancer-causing strains of HPV. The objectives of the study included the assessment of the safety and tolerability of PDS0101 and the confirmation of the Versamune platform’s mechanism of action. The study showed that PDS0101 overcame a key immunotherapy limitation by accessing an immunologic pathway that trains and activates killer T-cells to target cancer proteins.

The company intends to launch a Phase 2 study in collaboration with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of PDS0101 with Keytruda (pembrolizumab) in people with recurrent or metastatic head and neck cancer and high-risk HPV16 infection after chemotherapy treatment has failed.

Further Phase 2b studies also are planned to evaluate PDS010 in multiple HPV-advanced cancer and HPV pre-cancer.


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