Brenus Pharma announces FDA acceptance of IND application for STC-1010 (BreAK-CRC001) in MSS metastatic Colorectal Cancer (mCRC)

• STC-1010 is a first-in-class allogeneic in vivo immunotherapy for which the FDA has authorized clinical evaluation in the U.S. under the BreAK-CRC 001 study.

• This strategic milestone enables the company to execute a global clinical strategy following European regulatory approvals (ANSM, AFMPS), first patients dosed with preliminary results and good tolerability observed in early Phase Ia.

• First data are expected to be presented during ESMO annual congress 2026.

Lyon, 27th May – Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FDA validated Brenus Pharma’s advanced regulatory and manufacturing capabilities. This operational readiness will accelerate patient access and data generation across both European and US sites for a Phase II program planned for 2027.

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