STC-1010 Targets MSS Metastatic Colorectal Cancer
Brenus Pharma’s Investigational New Drug (IND) application for STC-1010 has been accepted by the U.S. Food and Drug Administration (FDA), allowing the company to begin clinical evaluation for treating microsatellite stable (MSS) metastatic colorectal cancer (mCRC) in the United States.
STC-1010 is an innovative allogeneic in vivo immunotherapy designed to address the significant challenge of MSS tumours, which make up approximately 95% of mCRC cases and show minimal response to existing immunotherapies. This FDA acceptance follows prior European regulatory approvals and enables Brenus Pharma to pursue a comprehensive global clinical strategy.
Preliminary results from early Phase Ia trials have already shown promising tolerability. The company plans to present initial data at the ESMO annual congress in 2026, highlighting the potential of STC-1010 to generate effective immune responses in mCRC patients.
Paul BRAVETTI, CEO of Brenus Pharma, stated, “FDA’s acceptance of our IND represents a major validation of our programme and enables the full execution of our clinical strategy across Europe and the United States. Achieving regulatory alignment across multiple jurisdictions reflects our team’s deep expertise and our commitment to bringing STC-1010 to patients who need it.”
Future Developments and Clinical Trials
The FDA’s approval is a critical step forward, as Brenus Pharma aims to accelerate patient access and data generation across both European and US sites. The company is preparing for a Phase II programme set to begin in 2027, further advancing their innovative approach to treating solid tumours.
Dr. Diala EZZEDDINE, US-based Independent Board Director at Brenus Pharma, commented, “This is an impressive accomplishment for Brenus, opening the door to planned clinical programme expansion in the U.S. By generating de novo, multi-specific lymphocyte responses in immunologically ‘cold’ tumours, the therapy promises to address one of oncology’s biggest challenges.”
Brenus Pharma continues to develop its off-the-shelf platform, which harnesses precision technology to mimic tumour protein expression. This approach aims to make tumours more visible to the immune system, enabling adaptive immune responses in hard-to-treat solid tumours.
The first patients have already been dosed, and the early data will provide crucial insights into the therapy’s effectiveness and safety profile. Brenus Pharma’s ongoing commitment to precision medicine at scale is set to redefine treatment paradigms for mCRC patients globally.
Last updated: 29 June 2026, 11:59 am
