PDS Biotechnology (PDSB) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application filed in January 2025 to evaluate a combination of Versamune MUC1, its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma in patients who failed previous treatment. The National Cancer Institute, under its Cooperative Research and Development Agreement with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.
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