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.
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