NEW YORK – PDS Biotech on Thursday said the US Food and Drug Administration cleared its investigational new drug (IND) application for the MUC1-targeted immunotherapy Versamune MUC1 and IL-12 fused antibody-drug conjugate PDS01ADC as a treatment for MUC1-positive unresectable, metastatic colorectal carcinoma.
The firm will collaborate with the National Cancer Institute on a Phase I/II trial to evaluate the Versamune MUC1 and PDS01ADC combination in this colorectal cancer patient population, who are mismatch repair proficient, are microsatellite stable, and have failed previous treatment.
"These tumors are typically more resistant to current immunotherapy, such as immune checkpoint inhibitors, and second-line chemotherapy," PDS Biotech Chief Medical Officer Kirk Shepard said in a statement. "Targeting MUC1 with an immunotherapy that elicits a strong and durable tumor-infiltrating T-cell response could represent a major advancement in cancer treatment."
MUC1 is overexpressed in several solid tumors, including colon, pancreatic, ovarian, breast, and non-small cell lung cancer and is associated with poor outcomes and treatment resistance.
PDS, based in Princeton, New Jersey, is also developing an HPV-targeted Versamune immunotherapy, which it is studying in combination with other drugs in several trials, including with Merck's Keytruda (pembrolizumab), chemotherapy, or PDS01ADC in HPV16-positive head and neck cancer. The firm's pipeline also includes a TARP-targeted Versamune immunotherapy in preclinical development.