PARIS, France — October 23, 2026
Enterome SA, a clinical-stage biotechnology company developing OncoMimics™ off-the-shelf immunotherapies, announced final data from the Phase 1/2 AUDREY trial evaluating EO4010 in previously treated patients with mismatch repair-proficient (pMMR) metastatic colorectal cancer (mCRC). The study evaluated EO4010 in combination with nivolumab, with or without bevacizumab, and found that faster and greater expansion of tumor-targeting CD8 T cells was associated with longer overall survival. EO4010 induced expansion of CD8 T cells specific to its vaccine peptides in all patients, while 84% of patients developed CD8 T-cell responses against the corresponding tumor-associated antigen targets. The immune responses were detectable early in treatment and remained measurable at 10 months of follow-up. The findings will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, on October 25, under Abstract 859P. Enterome said the results extend observations previously reported with its OncoMimics candidate EO2463 in lymphoma to a solid tumor setting. The company considers the findings supportive of further clinical evaluation, although the survival association comes from a small, exploratory Phase 1/2 study and does not establish that EO4010 improves survival. The results add to ongoing research into immunotherapies designed to activate patients’ existing immune responses against cancer-associated targets.
AUDREY Study Shows Early and Sustained T-Cell Expansion
The open-label, multicenter AUDREY trial (EOCRC2-22; NCT05589597) enrolled 25 patients with unresectable pMMR metastatic colorectal cancer whose disease had progressed after treatment with oxaliplatin, irinotecan, fluoropyrimidines and anti-VEGF or anti-EGFR therapy. Twenty patients received EO4010 plus nivolumab in Cohorts 1 and 2, while five received EO4010 with nivolumab and bevacizumab in Cohort 3. Patients in the first two cohorts had received a median of three prior systemic treatment lines for metastatic disease. EO4010-specific CD8 T-cell expansion was detected in 100% of patients, and expansion of CD8 T cells targeting the tumor-associated antigens mimicked by the vaccine was observed in 84%. Responses appeared rapidly: 81% of patients had detectable peptide-specific CD8 T-cell expansion after two to three administrations, while 71% had detectable expansion against the corresponding tumor-associated antigens by weeks five to six. Specific CD8 T cells remained detectable at 10 months of follow-up. These findings are relevant to pMMR colorectal cancer, a population in which checkpoint inhibitor monotherapy generally has limited activity. EO4010 is designed to stimulate pre-existing memory CD8 T cells that recognize microbial-derived peptides and cross-react with cancer-associated antigens. The study assessed safety, tolerability, immunogenicity and preliminary antitumor activity; its small sample size means that the findings require confirmation in larger controlled trials.
Survival Association and Preliminary Clinical Activity
In Cohorts 1 and 2, faster and greater expansion of tumor-targeting CD8 T cells was associated with longer overall survival in univariate analyses. Across all cohorts, patients who demonstrated week-five expansion of CD8 T cells specific to BIRC5 (survivin), or to EO2317, the EO4010 peptide designed to mimic BIRC5, lived longer than patients without the corresponding expansion. For BIRC5-specific responses, the reported hazard ratio was 0.27 (95% confidence interval [CI], 0.08–0.91; nominal log-rank p=0.024). For EO2317-specific responses, the hazard ratio was 0.15 (95% CI, 0.03–0.69; nominal log-rank p=0.005). These analyses included 21 evaluable patients. Median overall survival was 11.3 months in Cohorts 1 and 2 (95% CI, 7.1 months to not reached), with a median follow-up of 16.8 months. Median overall survival had not been reached in Cohort 3 (95% CI, 9.7 months to not reached), where median follow-up was 12 months. Disease control was achieved in six of 25 patients (24%), with a median duration of disease control of 5.5 months. One patient experienced a partial response, including 47% shrinkage of liver metastases and 34% shrinkage of lung metastases, lasting 8.7 months. Enterome reported that exploratory analyses did not indicate that subsequent anticancer treatments accounted for the observed survival association. Nevertheless, the analyses were exploratory, and the p-values were nominal; the results should not be interpreted as proof of a causal survival benefit.
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EO4010 Safety Profile and OncoMimics Platform Development
EO4010 was reported to be well tolerated in combination with nivolumab, with or without bevacizumab. The most common treatment-related adverse event was a local administration-site reaction, occurring in 84% of patients. The only related Grade 3 events were two administration-site reactions, and no Grade 4 or Grade 5 treatment-related adverse events were reported. EO4010 comprises five synthetic microbial-derived peptides—EO2317, EO2318, OMP10, OMP11 and OMP12—designed to mimic CD8 T-cell epitopes associated with BIRC5, FOXM1, UBE2C, CDC20 and KIF2C, alongside the helper peptide UCP2. These tumor-associated antigens are linked to cell-cycle regulation and are upregulated in metastatic colorectal cancer. Enterome’s OncoMimics™ platform uses peptide sequences selected from a proprietary database of microbial genes to stimulate cross-reactive immune responses against tumor-associated targets. The multi-target design aims to broaden immune recognition and reduce the potential for tumors to evade treatment by losing individual antigens. Enterome has previously reported associations between EO2463-induced CD8 T-cell expansion and clinical outcomes in patients with indolent non-Hodgkin lymphoma and expects to present further EO2463 data at the American Society of Hematology Annual Meeting in December 2026. The company said the EO4010 results support continued investigation of OncoMimics in solid tumors, while further studies will be needed to establish the magnitude and durability of any clinical benefit.
Source: Enterome, press release
