• Survival in 20 patients with MSS/pMMR mCRC at a median follow-up of 15.4 months was 40% at 12 months; median survival is currently 11.3 months
• Survival has currently reached plateau, with 34% (7/20) of patients still alive
• 80% of patients treated with EO4010/nivolumab showed specific immune responses against tumor associated antigens targeted by the OncoMimics™ immunotherapy
• EO4010 continues to demonstrate excellent safety and tolerability
• Data support further development of EO4010 to treat colorectal cancer
  
  

Paris, France – 30 May, 2025

Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, announces it will present 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, taking place in Chicago, IL, May 30-June 3. The poster presentation (Abstract #3536) will be given in the poster session Gastrointestinal Cancer—Colorectal and Anal (poster board 205) on May 31 from 9:00 AM – 12:00 PM CDT, and will be available for download.

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 tumor 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-tumor 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 tumor impact by EO4010 as measured by CT scan tumor shrinkages and CEA/CA19-9 tumor 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.”

Dr. Arvind Dasari, Professor at the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center, University of Texas, who is a principal investigator and will present the AUDREY data at ASCO, said: “The preliminary AUDREY findings support continued development of EO4010 for colorectal cancer. Treatment options for metastatic colorectal cancer remain limited, and the interim data generated on EO4010 so far indicate that it might add to the treatment possibilities for CRC. EO4010 has shown it can induce targeted immune responses and shrinkage of metastases.”

AUDREY (EOCRC2-22/NCT05589597) is a multicenter, open-label Phase 1/2 trial investigating EO4010 as monotherapy and in combination with nivolumab +/- bevacizumab for treatment of patients with unresectable, previously treated, MSS/pMMR mCRC. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in patients enrolled at sites in Europe and the USA.

Poster presentation (Abstract #3536)
Title: Survival of patients (pts) with microsatellite stable/mismatch repair proficient (MSS / pMMR) metastatic colorectal carcinoma (mCRC) treated with EO4010 + nivolumab (EO/N)
Poster Session: May 31, 9:00 AM – 12:00 PM CDT
Session title: Gastrointestinal Cancer - Colorectal and Anal
Poster Board: 205

OncoMimics™ immunotherapies are designed to activate pre-existing effector memory T cells against bacterial (non-self) peptides that strongly cross-react with corresponding Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer cells. TAAs escape detection through a process known as Thymic deletion, whereby the immune system learns not to attack “self” proteins. OncoMimics™ work by tricking the immune system because they are different enough from TAAs to raise an immune response that is specific to the OncoMimics™ and also against the TAAs, thereby mounting a natural and potent immune response against cancer.

EO4010, Enterome’s third clinical-stage OncoMimics™ candidate, combines five microbial-derived peptides that mimic HLA-A2 restricted CD8+ T cell epitopes from five TAAs: BIRC5/survivin, FOXM1, UBE2C (UBCH10), CDC20, and KIF2C (MCAK). It also includes a CD4 helper peptide, Universal Cancer Peptide 2 (UCP2), to bolster immune activation.

Colorectal cancer (CRC) is the third most common cancer in men and the second in women, contributing to 10% of all cancers worldwide. It is the fourth most common cause of cancer-related death, with more than 600,000 deaths annually. Despite all efforts with surgery and adjuvant therapy, 25% of patients with localized CRC later develop metastases, and around 20% of cases are metastatic at diagnosis. Thus, CRC continues to be a major therapeutic challenge with a considerable number of patients experiencing premature death, fewer than 20% of those diagnosed with recurring/metastatic disease surviving beyond 5 years from diagnosis.

Enterome SA (www.enterome.com) is a privately held clinical-stage biopharmaceutical company developing breakthrough OncoMimics™ immunotherapeutics for cancer. The three most advanced product candidates have shown positive early data in Phase 2 clinical development, supporting novel OncoMimics™ modality. The company’s pioneering approach to drug discovery is based on the unique and powerful bacterial Mimicry drug discovery platform, which allows it to discover OncoMimics™ with high similarity to tumor associated antigen (TAA) based on the big-data insights from millions of gut bacterial proteins, that live in humans.

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