PDS Biotech announces FDA clearance of IND for Versamune MUC1 + PDS01ADC to treat metastatic colorectal cancer

PDS Biotechnology Corp

FDA cleared IND for Versamune MUC1 (formerly PDS0103) + PDS01ADC to treat MUC1-positive unresectable metastatic colorectal carcinoma in failed prior treatment.
Phase 1/2 trial will be led by the National Cancer Institute under a CRADA with PDS Biotech.
MUC1 is over-expressed in colon, pancreatic, ovarian, breast, and NSCLC; study targets MSS mCRC, which accounts for 95% of mCRC patients.
U.S. Patent #12,201,685 covers methods of using Versamune platform and immunocytokines including PDS01ADC.
Company's primary focus remains on VERSATILE-003 Phase 3 trial in HPV16-positive head and neck squamous cell carcinoma.

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