PDS Biotech will advance PDS0301 into Phase 2b after Phase 2 data showed a 71% 6-month response rate in metastatic MSS/pMMR colorectal cancer.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
PDS Biotechnology is prioritizing its tumor-targeted immunocytokine PDS0301 after a strategic review of its oncology portfolio and capital requirements. The company will advance PDS0301 into a randomized Phase 2b program, while discontinuing internal investment in the Phase 3 VERSATILE-003 trial of PDS0101 and pursuing strategic partnerships or other external funding for its continued development.
Phase 2 Data Support PDS0301 in mCRC
The strategic shift follows clinical findings in patients with metastatic microsatellite stable (MSS) and mismatch repair-proficient (pMMR) colorectal cancer, particularly those with liver metastases, a population with limited treatment options and poor outcomes.
Data generated in collaboration with the National Cancer Institute showed a 71% objective response rate at six months and an 80% 24-month survival rate among patients with metastatic MSS/pMMR colorectal cancer and liver metastases. The company also cited an encouraging safety profile across more than 380 patients treated with PDS0301.
PDS Biotech said these results support further evaluation of the drug in difficult-to-treat solid tumors, although the findings will require confirmation in randomized studies.
Tumor Microenvironment as the Therapeutic Target
PDS0301 is a tumor-targeted immunocytokine that the company is developing to remodel the tumor microenvironment and enhance antitumor immune activity. Rather than targeting a single oncogenic pathway, the approach is intended to alter the tumor environment in ways that could improve the effectiveness and durability of other cancer therapies.
The company is evaluating PDS0301 in combination with established and emerging treatment classes, including RAS pathway inhibitors, bispecific antibodies, antibody-drug conjugates, radioligand therapies and immunotherapies.
Beyond colorectal cancer, clinical development includes recurrent prostate cancer, metastatic castration-resistant prostate cancer, Kaposi sarcoma and HPV16-positive cancers, alongside additional National Cancer Institute-sponsored studies (NCT05286814).
PDS0101 Phase 3 Program Discontinued
PDS Biotech will discontinue the Phase 3 VERSATILE-003 trial (NCT06790966) of PDS0101 and stop further internal investment in the program. Management said the decision reflects the capital, time and resources required to complete the study and support potential commercialization rather than a change in its assessment of the underlying clinical data.
The company now intends to preserve the potential value of PDS0101 through strategic partnerships or externally funded development.
Phase 2b Program Planned
Over the next 18 to 24 months, the company plans to advance PDS0301 through a randomized Phase 2b program incorporating feedback received from the FDA. The study is expected to generate additional controlled clinical evidence while maintaining tighter capital discipline.
CEO Frank Bedu-Addo said the company believes PDS0301 offers the strongest opportunity within its portfolio because of its clinical activity across multiple difficult-to-treat solid tumors, combination potential and existing safety experience.
The immediate priority is therefore to establish whether the encouraging Phase 2 findings in metastatic colorectal cancer can translate into reproducible benefit in a randomized setting. Success could determine the broader development path for PDS0301 across solid tumors and combination regimens.
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About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.