Phase Ia BreAK CRC-001 at ESMO 2026: 43% of patients, all initially unresectable, became eligible for surgery
Poster 1023P – Developmental Therapeutics
Brenus Pharma, a clinical-stage biotech company, announced first data from the Phase Ia dose escalation of BreAK CRC-001. Nine unresectable patients were treated; 89% had liver metastases and 89% KRAS-mutant tumors, a population refractory to immunotherapy. Median follow-up: 8 months (1–14; data cut-off 6/08/2026).
95% of metastatic colorectal cancers are pMMR/MSS tumors, poorly immunogenic and resistant to immunotherapy. STC-1010, the company’s lead in vivo DC-engager, is designed to make these “cold” tumors visible to immune cells.
- Safety: no dose-limiting toxicity, only grade 1–2 related adverse events.
- Clinical activity (seven evaluable patients, RECIST 1.1): 100% disease control, 57% objective response rate (4/7).
- 43% of patients became operable (3/7): two with no evidence of disease afterward.
- Molecular profile: ctDNA dropped by up to 97% within two months, TP53 and KRAS mutations near undetectable.
- Immune activity (first six patients) : STC-1010 regimen nearly quadrupled cytotoxic CD8+ T-cell infiltration in tumors (+285% T2 vs baseline) and increased the CD4+/Treg ratio 2.5-fold (p<0.05). Circulating T cells increased, consistent with trafficking to the tumor. In the presented patient case, profiling showed intratumoral antigen-presenting macrophages, a peripheral shift of T cells toward a memory phenotype, and expansion of tumor-reactive PD-1+CD39+ cells.
“These data validate STC-1010’s safety. They reinforce our hypotheses with early efficacy signals and the potential to improve the therapeutic landscape of cold tumor,” said Paul BRAVETTI , CEO of Brenus Pharma.
“Making initially unresectable patients eligible for surgery is what matters most in first-line metastatic colorectal cancer. Seeing it alongside immune activation in MSS tumors is a remarkable signal for patients,” said Prof. François GHIRINGHELLI , Centre Georges-François Leclerc, Dijon, principal investigator.
About BreAK CRC-001 ( NCT06934538 ) is an international, open-label Phase I/II trial in unresectable locally advanced or metastatic pMMR/MSS, BRAF wild-type CRC. STC-1010 is administrated with oral low-dose cyclophosphamide per os ± GM-CSF, in frontline combined with chemotherapy.
Brenus Pharma
Brenus Pharma develops an off-the-shelf platform advancing novel modalities in immuno-oncology. This precision technology mimics tumor protein expression and makes it visible to the immune system, enabling a multi-specific in vivo immune response adapting to tumor evolution in hard-to-treat solid tumors, where current therapies fall short.
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