Brenus Pharma announced on May 27, 2026, that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for STC-1010. The drug candidate is being developed for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
The acceptance allows for clinical evaluation of STC-1010 in the United States under the BreAK-CRC001 study. This follows earlier regulatory approvals from European agencies, including ANSM and AFMPS. Brenus Pharma has stated that preliminary results from early Phase Ia studies have shown good tolerability.
STC-1010 is described as a first-in-class allogeneic in vivo immunotherapy. The company highlighted that approximately 95% of mCRC patients have MSS tumors, which are known to respond poorly to standard immunotherapies, indicating a significant unmet medical need.
Brenus Pharma's CEO, Paul Bravetti, noted that the FDA's acceptance validates the program and enables the execution of the company's clinical strategy across Europe and the United States. The company plans to initiate a Phase II program in 2027, with initial data expected to be presented at the ESMO annual congress in 2026. The FDA's acceptance also indicates validation of Brenus Pharma's manufacturing capabilities.
