Overview
PDS Biotech’s oncology products are designed to stimulate and enhance targeted T cell responses against cancers expressing tumor-specific proteins or peptides (antigens) and can be combined with standard of care treatments.
PDS0101 (formerly Versamune® HPV)
Product information
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.
Disease state
Almost 100,000 US patients are diagnosed with an 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.
Development status
PDS0101 is currently being evaluated by us in a Phase 3 clinical trial in combination with pembrolizumab as a first-line treatment for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma, as well as in Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.
PDS0103 (formerly Versamune® MUC1)
Product information
PDS0103 is a novel investigational mucin-1 (MUC1)-targeted immunotherapy that stimulates a potent targeted T cell attack against MUC1-positive cancers. PDS0103 is given by a simple subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. Preclinical data suggests PDS0103 generates clinically effective immune responses, and demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. PDS0103 combines the utility of the Versamune® platform with novel highly immunogenic agonist epitopes of MUC1 developed in by the National Cancer Institute (NCI).
Disease state
MUC1 is over-expressed in multiple solid tumors and has been shown to be associated with drug resistance and poor patient outcomes. MUC1-positive cancers such as ovarian, breast, colorectal and lung cancers can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently MUC1-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and MUC1-targeted treatment options.
Development status
PDS0103 is currently in early-stage clinical development.
PDS0102 (formerly Versamune® TARP)
Product information
PDS0102 is a novel investigational T cell receptor gamma alternate reading frame protein (TARP)-targeted immunotherapy that stimulates a potent targeted T cell attack against TARP-positive cancers. PDS0102 is given by a simple subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. Preclinical data suggests PDS0102 generates clinically effective immune responses, and demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. PDS0102 combines the utility of the Versamune® platform with this proprietary TARP antigen developed by the National Cancer Institute (NCI).
Disease state
Approximately 450,000 patients are diagnosed with acute myeloid leukemia (AML), prostate or breast cancer each year, most of which are associated with TARP. TARP-positive cancers that overexpress the immunogenic TARP protein such as prostate and breast cancer can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently TARP-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and TARP-targeted treatment options.
Development status
PDS0102 is currently in late-stage pre-clinical development.
PDS01ADC
Product information
PDS01ADC (formerly PDS0301, M9241 and NHSIL12) is a novel investigational Interleukin 12 (IL-12) fused antibody-drug conjugate (ADC) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS01ADC works synergistically to promote a targeted T cell attack against cancers. PDS01ADC is given by subcutaneous injection. PDS01ADC is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response of Versamune® based immunotherapies. Clinical data suggest the addition of PDS01ADC to Versamune® based immunotherapies demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis.
Disease state
Recurrent/metastatic cancer is cancer that has returned after initial treatment or has spread to another part of the body. The survival prognosis for these types of cancers is generally poor. Surgery, chemotherapy and radiation therapy are cornerstones of cancer treatment in the recurrent/metastatic setting. Complementary therapies delivered in combination are often needed to combat advanced, recurrent metastatic disease.
Development status
PDS01ADC is currently being evaluated in combination with Versamune® based immunotherapies in both preclinical and clinical programs for the treatment of various types of recurrent/metastatic cancers.
About PDS01ADC
PDS01ADC (formerly PDS0301, M9241 and NHSIL12) is a novel investigational Interleukin 12 (IL-12) fused antibody-drug conjugate (ADC) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. PDS01ADC is given by a subcutaneous injection. PDS01ADC is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.