PDS Biotechnology Corporation (Nasdaq: PDSB) announced a strategic refocus, prioritizing its tumor-targeted immunocytokine PDS0301 for metastatic colorectal cancer (mCRC) while seeking external partners for its PDS0101 program.

The Princeton, N.J.-based company said its board and management conducted a comprehensive review of its development portfolio and capital allocation priorities before reaching the decision. As part of the shift, PDS Biotech said it will discontinue its VERSATILE-003 Phase 3 trial for PDS0101 and pursue strategic partnerships or other externally funded arrangements for that program's continued development.

The company cited Phase 2 clinical data generated in collaboration with the National Cancer Institute as a key factor in its decision to concentrate resources on PDS0301. That data showed a 71% objective response rate at six months and an 80% 24-month survival rate in patients with metastatic microsatellite stable and mismatch repair-proficient colorectal cancer with liver metastases. By comparison, median overall survival in this patient population is reported at less than 10 months, with objective response rates below 25%, according to a cited literature review.

PDS0301 has been administered to more than 380 patients across multiple solid tumor types. The drug is also being evaluated in recurrent prostate cancer, metastatic castration-resistant prostate cancer, Kaposi sarcoma, HPV16-positive cancers, and other National Cancer Institute-sponsored trials.

The company said a randomized Phase 2b trial for PDS0301 has been designed incorporating feedback from the U.S. Food and Drug Administration. Over the next 18 to 24 months, PDS Biotech said it expects to advance PDS0301 through the Phase 2b program, identify partnership opportunities for PDS0101, and maintain disciplined capital allocation.

Chief Executive Officer Frank Bedu-Addo, Ph.D., said the decision to halt internal investment in PDS0101 "reflects our commitment to disciplined capital allocation rather than a change in our view of the underlying PDS0101 science and clinical data."

PDS Biotech said it plans to report financial results for the quarter ending June 30, 2026, on August 13, 2026.