PDS Biotech Expands Phase 2 Colorectal Cancer Trial After Positive Results

BioNTech SE and PDS Biotechnology are advancing Phase II clinical trials targeting colorectal cancer, reflecting ongoing efforts to improve treatment outcomes for this deadly disease. BioNTech's trial evaluates the intravenous drug RO7198457 against watchful waiting in high-risk Stage II and Stage III colorectal cancer patients who are ctDNA positive post-surgery, aiming to demonstrate enhanced efficacy. Meanwhile, PDS Biotechnology, in collaboration with the National Cancer Institute, completed Stage 1 patient recruitment for its PDS01ADC therapeutic combined with floxuridine via hepatic artery infusion pump for metastatic colorectal cancer; the trial met criteria for expansion into Stage 2, signifying promising initial responses. PDS01ADC is a novel fused antibody drug conjugate designed to target tumor necrosis areas with limited systemic IL-12 exposure, potentially reducing treatment-limiting toxicities. Both companies' clinical progress underscores the critical need for more effective colorectal cancer therapies, as the disease remains a leading cause of cancer-related deaths globally. These advancements may influence investor confidence and represent hopeful steps toward better patient outcomes.