PDS Biotechnology Corporation filed an 8-K on September 21, 2026, to incorporate a corporate presentation deck as Exhibit 99.1. The filing provides an overview of the company’s oncology drug development programs, highlighting two clinically advanced assets built on proprietary platforms designed to direct immune activity into tumors.
The first asset, PDS0301, is a tumor-targeted IL-12 immunocytokine. The company reported that in a National Cancer Institute-led Phase 2 trial for metastatic colorectal cancer with liver metastases, the combination of chemotherapy and PDS0301 achieved a 71.4% response rate at six months and approximately an 80% survival rate at 24 months. More than 380 patients have been dosed with PDS0301 to date. Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors. A registrational Phase 3 protocol for PDS0301 in metastatic colorectal cancer is currently in design.
The second asset, PDS0101 (Versamune HPV16 Cancer Vaccine), targets HPV16-positive head and neck cancer. Data from the VERSATILE-002 trial showed a median overall survival of 39.3 months when combined with pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer. The presentation notes that the published benchmark for this indication is 12 to 18 months. The VERSATILE-003 trial holds FDA Fast Track designation, and the company is seeking a strategic partnership or external funding for further development.
The filing outlines five near-term catalysts for PDS0301, including five data readouts anticipated between Q4 2026 and Q2 2028 across biochemically recurrent prostate cancer, metastatic castration-resistant prostate cancer, colorectal cancer with liver metastases, and Kaposi sarcoma.
