PDS0101 in combination with KEYTRUDA - (VERSATILE-003)

Aug. 11, 2026: PDS Biotechnology (NASDAQ: PDSB) said it is reprioritizing its pipeline to focus on PDS0301, an investigational tumor-targeted IL-12 immunocytokine, and will stop internal funding of PDS0101’s Phase 3 VERSATILE-003 trial while seeking strategic partnership or other external funding for that program.

For PDS0301, the company highlighted Phase 2 metastatic colorectal cancer data generated with the National Cancer Institute in metastatic microsatellite-stable/mismatch repair-proficient colorectal cancer with liver metastases: 71% objective response rate at 6 months and 80% 24-month survival. It also said safety has been observed in more than 380 treated patients. PDS0301 is being advanced as the lead program, with a randomized Phase 2b trial in mCRC designed based on FDA feedback.

The company said PDS0301 is also being evaluated in recurrent prostate cancer, metastatic castration-resistant prostate cancer, Kaposi sarcoma, HPV16-positive cancers, and other NCI-sponsored trials.

For PDS0101, PDS Biotech said the decision to discontinue VERSATILE-003 reflects capital allocation priorities rather than a change in its view of the program’s Phase 2 data, and it plans to look for partners to continue development.

The company expects over the next 18 to 24 months to advance PDS0301 Phase 2b and assess partnering options for PDS0101.