Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, presented new positive data from its ongoing Phase 1/2 “AUDREY” trial of its OncoMimics immunotherapy, EO4010, to treat microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, in Chicago, IL.
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Chicago, IL.
The poster presentation (Abstract #3536) was given in the poster session Gastrointestinal Cancer—Colorectal and Anal (poster board 205) on 31st May.
Pierre Bélichard, chief executive officer of Enterome, said: “These exciting interim clinical data exemplify the strong therapeutic potential of our OncoMimics immunotherapy for cancer. Current treatment options are limited for cancers like MSS/pMMR mCRC, and, so far, EO4010 has already delivered promising survival outcomes and objective responses including in liver metastases without complex side effects. We believe EO4010 will become a welcome addition to the therapeutic armamentarium for CRC and look forward to gaining more knowledge based on the current data.”
EO4010 combines five microbial-derived peptides that mimic HLA-A2 restricted CD8+ T cell epitopes from five human tumour associated antigens (TAAs) commonly observed in patients with CRC (BIRC5, FOXM1, UBE2C, CDC20 and KIF2C). Data from 20 patients with MSS/pMMR mCRC enrolled in the open label AUDREY trial showed that EO4010 plus nivolumab, with or without bevacizumab, was well tolerated.
EO4010 also generated fast, robust, and durable expansions of CD8+ T cells against the targeted TAAs causing clinically meaningful responses in this challenging patient population. Specifically, EO4010 plus nivolumab showed direct anti-tumour activity in MSS/pMMR mCRC. Survival in patients treated with EO4010 plus nivolumab at a median follow-up of 15.4 months, was 40% at 12-months and there is currently a plateau at 34% survival, with 7 of 20 patients still alive; the median survival is currently 11.3 months.
Jan Fagerberg, MD, PhD, chief medical officer of Enterome, said: “Objective response is a very rare event in immunotherapy in patients with MSS/pMMR mCRC; yet we observed direct tumour impact by EO4010 as measured by CT scan tumour shrinkages and CEA/CA19-9 tumour marker declines, including RECIST partial response in liver and lung metastases. This and the survival are exciting results and we look forward learning more about how to most effectively use EO4010 in CRC.”