LYON, France — May 28, 2026
Brenus Pharma announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for STC-1010 (BreAK-CRC001), a first-in-class allogeneic in vivo immunotherapy targeting microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The regulatory milestone authorizes clinical evaluation of the therapy in the United States and significantly advances the company’s global immuno-oncology strategy. The IND acceptance follows earlier regulatory approvals from European authorities including France’s ANSM and Belgium’s AFMPS, positioning Brenus Pharma to accelerate multinational clinical development of STC-1010 across both European and U.S. trial sites.
STC-1010 Targets a Major Unmet Need in Colorectal Cancer
STC-1010 is being developed to address one of the largest unmet needs in oncology, as approximately 95% of metastatic colorectal cancer patients present with MSS tumors that typically show little or no response to currently available immunotherapies. Unlike traditional checkpoint inhibitors that struggle against immunologically “cold” tumors, STC-1010 is designed to stimulate a multi-specific in vivo immune response capable of adapting to tumor evolution. The therapy uses Brenus Pharma’s proprietary platform that mimics tumor protein expression, making cancer cells more visible to the immune system and potentially improving immune recognition in difficult-to-treat solid tumors.
The FDA’s acceptance of the IND application also validates the company’s growing expertise in regulatory execution, manufacturing scalability, and operational readiness. Brenus Pharma stated that the milestone will help accelerate patient recruitment and clinical data generation ahead of a broader Phase II clinical program planned for 2027. Early Phase Ia clinical observations have already demonstrated encouraging tolerability and preliminary activity, supporting continued expansion of the development program.
Global Clinical Expansion Gains Momentum
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According to the company, first clinical data from the BreAK-CRC001 study are expected to be presented during the European Society for Medical Oncology (ESMO) Annual Congress 2026, an important upcoming milestone that could provide early insight into the therapy’s safety and efficacy profile. The company believes the combination of U.S. IND authorization and existing European approvals creates a strong foundation for synchronized global development and future commercialization opportunities.
Paul Bravetti, CEO of Brenus Pharma, described the FDA acceptance as a major validation of the company’s scientific and clinical strategy. He noted that achieving regulatory alignment across multiple international jurisdictions reflects the company’s operational capabilities and long-term commitment to delivering new therapeutic options for patients with advanced colorectal cancer who currently have limited treatment alternatives.
Dr. Diala Ezzeddine, U.S.-based Independent Board Director at Brenus Pharma, emphasized the broader significance of the technology platform, stating that the therapy’s ability to generate de novo lymphocyte responses in immunologically resistant tumors could help overcome one of oncology’s most persistent challenges. She also highlighted the strategic importance of expanding the company’s clinical presence into the United States market.
Brenus Pharma Strengthens Position in Immuno-Oncology
Founded as a clinical-stage biotechnology company focused on solid tumors, Brenus Pharma is developing an off-the-shelf immunotherapy platform designed to deliver precision medicine at scale. The company combines data-driven tumor modeling with scalable GMP manufacturing to create novel immuno-oncology approaches for cancers where existing therapies remain insufficient. With FDA clearance now secured for STC-1010, Brenus Pharma strengthens its position within the rapidly evolving global immunotherapy and colorectal cancer treatment market, where demand for innovative therapies targeting resistant solid tumors continues to grow.
Source: Brenus Pharma press release
