PDS Biotechnology Corporation filed a Current Report on Form 8-K dated October 20, 2026, to incorporate by reference a corporate presentation titled "Overview of PDS Biotech Drug Development Programs (Oncology)." The filing details the company's strategy focusing on two clinically advanced immunotherapy assets built on proprietary platforms, with development activities conducted in partnership with the National Cancer Institute.
The presentation highlights PDS0301, a tumor-targeted IL-12 immunocytokine, which has been administered to more than 380 patients in clinical trials. In a non-randomized Phase 2 trial for microsatellite stable (MSS) or mismatch repair-proficient (pMMR) metastatic colorectal cancer with liver metastases, the combination of chemotherapy and PDS0301 achieved an objective response rate of 71.4% at six months. The data also indicates a 24-month survival rate of approximately 80% for patients receiving the combination therapy, compared to a benchmark response rate of less than 30%.
Regarding PDS0101, a Versamune HPV16 cancer vaccine, the presentation notes that VERSATILE-002 reported a median overall survival of 39.3 months in combination with pembrolizumab for first-line HPV16-positive recurrent/metastatic head and neck cancer. The company states that the published benchmark for this indication is 12 to 18 months. PDS0101 holds FDA Fast Track designation for VERSATILE-003.
The filing also discloses that following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors. The company anticipates five data readouts for PDS0301 between the fourth quarter of 2026 and the second quarter of 2028 across various indications, including biochemically recurrent prostate cancer and metastatic castration-resistant prostate cancer.
