PDS Biotechnology Corporation has announced that the colorectal cancer cohort in their Phase 2 clinical trial met criteria for expansion to Stage 2, following positive results from Stage 1. The trial involves the systemic administration of the PDS01ADC therapeutic in combination with floxuridine via a hepatic artery infusion pump for patients with metastatic colorectal cancer. Conducted by the National Cancer Institute, the study demonstrated a promising response rate, triggering an enrollment expansion under the Simon Two-Stage Design. PDS01ADC is a fused antibody drug conjugate targeting tumor necrosis regions, potentially allowing for cytokine therapy benefits with reduced systemic exposure and treatment-limiting toxicities. The company anticipates the completion of patient recruitment for this cohort by the fourth quarter of 2025. Results from Stage 1 have already been presented, leading to the expansion of the study.
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