08:34 AM EDT, 03/13/2025 (MT Newswires) -- PDS Biotechnology ( PDSB ) said Thursday the US Food and Drug Administration cleared its new drug application for a clinical trial to evaluate a combination of its investigational immunotherapy Versamune MUC1 and PDS01ADC to treat metastatic colorectal cancer.

The company said the National Cancer Institute will lead the phase 1/2 trial under a Cooperative Research and Development Agreement.

The combination potentially targets tumors expressing MUC1, a protein linked to drug resistance and poor outcomes in several cancers, according to PDS.

Shares of the company were up 6.7% in recent premarket trading.