Enterome's EO4010 Shows Promising Survival Benefits in Colorectal Cancer

Paris, France, 23 October 2026, Enterome SA, a clinical-stage company pioneering OncoMimics™, a new class of off-the-shelf, multi-targeted in vivo immune therapies, today announced final data from the Phase 1/2 AUDREY study of OncoMimics™ EO4010 in combination with nivolumab, with or without bevacizumab, in patients with mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC) previously treated with standard chemotherapy and anti-VEGF or anti-EGFR therapy. The data show that EO4010 expands CD8 T cells directed at the tumor-associated antigens it mimics in most patients, and that fast and high-level expansion of these tumor-targeting CD8 T cells is associated with longer overall survival.

The study, which is being presented on 25 October 2026 in a poster at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (Abstract 859P), by presenting author Dr. Elena Élez Fernandez, Vall d’Hebron University Hospital, Barcelona, found that EO4010 was well tolerated and expanded tumor-targeting CD8 T cells in most patients, with expansion detectable after two to three administrations. The most common treatment-related adverse event was a local administration site reaction (84% of patients), with the only related grade 3 events being two local administration site reactions, and no grade 4 or 5 events.

In the Phase 1/2 AUDREY trial, which treated 25 patients with unresectable pMMR mCRC whose disease had progressed after oxaliplatin, irinotecan, fluoropyrimidines, and anti-VEGF or anti-EGFR therapy, EO4010-induced expansion of CD8 T cells specific for the EO4010 peptides and for their tumor-associated antigen targets was detected in 100% and 84% of patients, respectively. Expansion was fast, with 81% and 71% of patients positive after two to three administrations (weeks 5-6), and durable, with specific CD8 T cells still detectable at 10 months of follow-up.

Disease control was achieved in 6 of 25 patients (24%), with a median duration of disease control of 5.5 months, including one partial response with 47% shrinkage of liver metastases and 34% shrinkage of lung metastases lasting 8.7 months. Median overall survival was 11.3 months (95% CI 7.1, not reached) in Cohorts 1 and 2, with a median follow-up of 16.8 months, and was not reached in Cohort 3 (95% CI 9.7, not reached; median follow-up 12.0 months).

Across all cohorts, patients with expansion at week 5 of CD8 T cells specific for BIRC5, or for the EO4010 peptide EO2317 that mimics BIRC5, lived longer than patients without such expansion (BIRC5: HR 0.27, 95% CI 0.08-0.91, log-rank p=0.024; EO2317: HR 0.15, 95% CI 0.03-0.69, log-rank p=0.005; n=21 evaluable patients). All p-values are nominal. Exploratory analyses indicate that anti-cancer treatments received after the study do not account for the survival signal.

Earlier this year, Enterome reported at the European Hematology Association (EHA) Congress and the Pan Pacific Lymphoma Conference (PPLC) that EO2463-induced CD8 T-cell expansion was associated with objective response, complete response, and progression-free survival in patients with indolent non-Hodgkin lymphoma. Enterome expects to present further EO2463 data at the American Society of Hematology (ASH) Annual Meeting in December 2026.