On March 13, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug ("IND") application filed in January 2025 to evaluate a combination of Versamune MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ("mCRC") in patients who failed previous treatment (Press release, PDS Biotechnology, MAR 13, 2025, View Source [SID1234651130]).
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"MUC1 is over-expressed in multiple solid tumors including colon, pancreatic, ovarian, breast, and NSCLC, and is associated with drug resistance and poor patient outcomes. This results in an unmet need for more effective, safer, better-tolerated targeted treatment options. Versamune MUC1 targets mCRC tumors that are MUC1-positive and will be studied in Proficient Mismatch Repair/Microsatellite Stable mCRC, which accounts for 95% of patients with mCRC. These tumors are typically more resistant to current immunotherapy, such as immune checkpoint inhibitors, and second-line chemotherapy," said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. "Targeting MUC1 with an immunotherapy that elicits a strong and durable tumor-infiltrating T-cell response could represent a major advancement in cancer treatment."
The National Cancer Institute ("NCI"), under its Cooperative Research and Development Agreement ("CRADA") with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.
"The IND clearance of Versamune MUC1 marks progress for our Versamune platform and its potential to expand beyond HPV-related cancers," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Though our focus remains on our recently initiated VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma, we are pleased to support the NCI investigation of a therapy that shows promise in driving strong, durable anti-tumor immune responses."
U.S. Patent #12,201,685 covers the methods of using the proprietary combination of Versamune and cytokines to overcome immune suppression in the tumor and improve the anti-tumor immune response.