PDS Biotechnology will prioritize the IL-12 immunocytokine PDS0301 in metastatic colorectal cancer and pursue a partnership strategy for PDS0101.
PDS Biotechnology Corporation will direct its capital and development resources toward PDS0301, an investigational tumor-targeted IL-12 immunocytokine, while pursuing strategic partnerships for the continued development of PDS0101.¹
The strategic refocus follows data from a phase 2 trial (NCT05286814) showing a 71% objective response rate (ORR) at 6 months and an 80% 24-month overall survival (OS) rate among patients with metastatic microsatellite stable (MSS) and mismatch repair-proficient (pMMR) colorectal cancer (CRC) with liver metastases treated with PDS0301, generated in collaboration with the National Cancer Institute.1,2 As part of the refocus, the company will discontinue internal funding of the phase 3 VERSATILE-003 trial (NCT06790966) evaluating PDS0101 in patients with recurrent/metastatic head and neck squamous cell carcinoma and will pursue external partnerships or other externally funded opportunities to continue that program.1
In a letter to shareholders accompanying the announcement, Frank Bedu-Addo, PhD, chief executive officer and director of PDS Biotech, outlined the rationale for prioritizing PDS0301 over continued internal investment in PDS0101. "We concluded that our resources should be redirected toward PDS0301, where we believe the combination of encouraging clinical data, development opportunity and capital requirements provide a potentially more attractive path to long-term shareholder value," he wrote.¹
In the phase 2 interim analysis conducted with the NCI evaluating PDS0301 with hepatic artery infusion pump therapy for colorectal liver metastases, investigators reported a 71% ORR at 6 months and an 80% 24-month OS rate in this population.² Across the broader clinical program, PDS0301 has been evaluated in more than 380 treated patients, with the company reporting an "encouraging safety and tolerability profile" and clinical activity observed as monotherapy and in doublet and triplet combinations across multiple difficult-to-treat solid tumors.
A randomized phase 2b trial of PDS0301 has been designed incorporating feedback from the FDA and is intended to generate clinical data under disciplined capital investment, according to a news release.¹ Over the next 18 to 24 months, the company said it plans to advance PDS0301 through this phase 2b program, identify and assess strategic partnering opportunities for PDS0101, and maintain capital discipline while pursuing clinical and business milestones.
Beyond metastatic CRC, PDS0301 is also being evaluated in recurrent prostate cancer, metastatic castration-resistant prostate cancer, Kaposi sarcoma, HPV16-positive cancers, and other NCI-sponsored trials. PDS Biotechnology is scheduled to report financial results for the quarter ended June 30, 2026, on August 13, 2026.
“The oncology treatment landscape is rapidly evolving with the emergence of various precision medicines,” Bedu-Addo added in the letter. “Despite these advances, treatment resistance and limited durability of response remain significant challenges for many patients with advanced solid tumors. Based on supportive preclinical and clinical data, we believe PDS0301 has the potential to address these challenges by precisely targeting and remodeling the tumor microenvironment, potentially enhancing the effectiveness and durability of current and emerging oncology therapies. To address this medical need, we have designed PDS0301 for use, in combination with other oncology therapies, to remodel the tumor microenvironment to potentially promote more effective anti-tumor responses in patients. We believe the remodeling of the tumor microenvironment is an important factor in addressing treatment resistance and reversing disease progression. Further, this mechanism could enable PDS0301 to complement a broad range of current and emerging oncology therapies, including RAS pathway inhibitors, bispecific antibodies, ADCs and radioligand therapies.”
