PDS Biotech cites 71.4% response rate for PDS0301 in colorectal cancer
PDS Biotechnology Corporation disclosed a 71.4% response rate at six months for PDS0301 in a Phase 2 trial for metastatic colorectal cancer. The data comes from an NCI-led study in patients with microsatellite stable or mismatch repair-proficient disease and liver metastases, where chemotherapy plus PDS0301 also showed approximately 80% survival at 24 months.
PDS Biotechnology Corporation disclosed a 71.4% response rate at six months for PDS0301 in a Phase 2 trial for metastatic colorectal cancer. The data comes from an NCI-led study in patients with microsatellite stable or mismatch repair-proficient disease and liver metastases, where chemotherapy plus PDS0301 also showed approximately 80% survival at 24 months.
The company stated that more than 380 patients have been dosed to date in these trials. Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors. The company noted his prior experience obtaining FDA approval for an immunocytokine. A registrational Phase 3 protocol for PDS0301 in metastatic colorectal cancer is currently in design.
PDS Biotechnology also detailed results for PDS0101, its Versamune HPV16 Cancer Vaccine. In the VERSATILE-002 trial, the combination of PDS0101 and pembrolizumab reported a 39.3-month median overall survival in first-line HPV16-positive recurrent or metastatic head and neck cancer. The company cited a published benchmark of 12 to 18 months for this indication. VERSATILE-003 holds FDA Fast Track designation, and the company is seeking a strategic alliance or external funding for further development of this asset.
The company anticipates five data readouts for PDS0301 between the fourth quarter of 2026 and the second quarter of 2028. These readouts are expected in studies covering prostate cancer with biochemical recurrence, metastatic castration-resistant prostate cancer, colorectal cancer with liver metastases, and Kaposi sarcoma.
PDS Biotechnology describes its platform as designed to concentrate immune activity in the tumor microenvironment while limiting systemic exposure. The company is developing these assets in partnership with the National Cancer Institute. The provided material includes forward-looking statements regarding the company's ability to protect intellectual property rights, anticipated capital requirements, and dependence on additional financing to fund operations and complete product development.
The company notes that actual results could differ materially from forward-looking statements due to various factors, including the timing and success of clinical trials and the company's ability to continue as a going concern. Versamune is a registered trademark of PDS Biotechnology Corporation. The presentation outlines a pipeline that includes PDS0301 combined with chemotherapy for advanced liver-associated cancers, including intrahepatic cholangiocarcinoma and metastatic adrenocortical carcinoma.