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PDS Biotech announces FDA clearance of IND apprlication for Versamune MUC1 combo

PDS Biotech announces FDA clearance of IND apprlication for Versamune MUC1 combo

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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