Brenus Pharma has achieved a significant milestone in colorectal cancer treatment by successfully dosing the first patients in its inaugural clinical trial of STC-1010, a next-generation in vivo immunotherapy. The French biotech company announced that three patients have been enrolled in the study, with the first patient completing eight weeks of treatment without experiencing any adverse events attributed to the investigational therapy.
The Phase I/IIa trial, designated "BreAK CRC-001," represents a critical advancement for patients with unresectable, locally advanced or metastatic colorectal cancer (stage IIIC or IV), a population for whom chemotherapy remains the predominant treatment option. Colorectal cancer stands as the second leading cause of cancer-related death worldwide, highlighting the urgent need for innovative therapeutic approaches.
Novel Immunotherapy Platform Targets Treatment-Resistant Tumors
STC-1010 emerges from Brenus Pharma's proprietary off-the-shelf platform, which employs cutting-edge precision technology to mimic tumor protein expression and enhance immune system visibility. This approach enables a multi-specific in vivo immune response against evolving tumor cells, addressing a critical gap in current treatment paradigms.
"This marks a pivotal step for Brenus and the future of new modalities in oncology with the potential to improve outcomes, with more accessible and scalable solution for patients who desperately need it," said Paul Bravetti, CEO of Brenus Pharma.
The therapy specifically targets a significant unmet medical need in colorectal cancer treatment. Current immunotherapies demonstrate efficacy only in dMMR/MSI-H "hot" tumors, leaving pMMR/MSS patients with limited options. François Ghiringhelli, M.D., Ph.D., Director of early clinical unit and study coordinator at CGFL, emphasized this challenge: "CRC remains challenging, as current immunotherapies are only effective in dMMR/MSI-H 'hot' tumors. For pMMR/MSS patients, there's a strong need for drugs that can 'heat up' cold tumors."
Comprehensive Trial Design and Timeline
The international, open-label, multicenter trial will evaluate STC-1010 in combination with an immunostimulatory regimen comprising GM-CSF low-dose and cyclophosphamide, alongside standard-of-care chemotherapy (mFOLFOX6 ± bevacizumab). The study aims to assess safety, tolerability, and preliminary efficacy in over 80 patients, with first results anticipated in the first half of 2026.
Initial trial sites have opened across France, including CGFL in Dijon, Institut Bergonié in Bordeaux, ICM in Montpellier, and HCL in Lyon. The study will expand to additional centers in France and Belgium in 2026, with further international expansion to the United States planned for the Phase II portion.
Clinical Significance and Future Implications
The successful initiation of this trial represents more than a scientific milestone for the field of immuno-oncology. "Treating the first patient represents more than a scientific milestone — It's a profoundly meaningful moment, marking the start of broader clinical and pharmaceutical deployment," noted Benoit Pinteur, co-founder and CSO of Brenus Pharma.
The trial's approval by French regulatory authorities positions STC-1010 as a potential first-line treatment option for patients with advanced colorectal cancer, potentially transforming the treatment landscape for this challenging patient population. The therapy's off-the-shelf platform design offers the promise of improved accessibility and scalability compared to personalized immunotherapy approaches.
As the study progresses, the medical community eagerly awaits data that could validate this novel approach to converting immunologically "cold" tumors into "hot" tumors responsive to immune-mediated destruction, potentially offering new hope for patients with limited therapeutic options.
