PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
Approximately 43,000 US patients are diagnosed with a HPV-related cancer each year, a number unlikely to be impacted in the next decade by the increased use of HPV preventive vaccines – given that the time from initial HPV infection to a cancer diagnosis is usually 20 years or more. Cancers such as head and neck, cervical, anal, penile, vaginal, vulvar that are caused by HPV infection can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently HPV-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies such as checkpoint inhibitors, either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and HPV-targeted treatment options.
PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.