Enterome announces first patient dosed in a Phase 1/2 trial with third OncoMimics™ immunotherapy, EO4010, in Metastatic Colorectal Cancer

Enterome announces first patient dosed in a Phase 1/2 trial with third OncoMimics™ immunotherapy, EO4010, in Metastatic Colorectal Cancer

EO4010 uniquely mimics five distinct tumor-associated antigens designed to provide multi-targeted, broad tumor coverage, maximizing tumor killing and preventing immune escape

Paris, France – June 30, 2023

Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announces that the first patient was dosed in the Phase 1/2 'AUDREY' trial evaluating EO4010, the Company's third OncoMimics™ candidate, for the treatment of patients with unresectable, previously treated, metastatic colorectal cancer (CRC).

EO4010 is an innovative, off-the-shelf immunotherapy that combines five synthetic OncoMimics™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) BIRC5/survivin, FOXM1, UBE2C, CDC20 and KIF2C. EO4010 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope.

The five selected TAAs are associated with critical cell-cycle functions and are highly expressed in CRC tumors but not significantly in healthy tissues. The selection of OncoMimics™ peptides corresponding to these TAAs ensures broad tumor coverage designed to overcome tumor heterogeneity and reduce tumor escape.

The AUDREY study (EOCRC2-22/NCT05589597) is a multicenter, open-label Phase 1/2 trial assessing safety, tolerability, immunogenicity and preliminary efficacy of EO4010 in monotherapy and in combination with the immune checkpoint inhibitor nivolumab for treatment of metastatic colorectal cancer. A total of 42 patients are expected to be enrolled in Europe and the US.

AUDREY represents the fourth trial investigating Enterome OncoMimics™ immunotherapy candidates in solid and liquid malignancies. The Company is also initiating a Phase 2 clinical study in patients with ctDNA-defined, Minimal Residual Disease of colorectal cancer, with its fourth candidate EO2040.

Dr. Romain Cohen, medical oncologist (MCU-PH) Department of medical oncology, Saint-Antoine hospital, AP-HP, and Assistant Professor of Oncology at Sorbonne University (Paris, France), is Coordinating Investigator for the AUDREY study in France. Dr. Cohen main clinical and research interests include the study of cancers harboring microsatellite instability, particularly their treatment with immune-oncology. He is principal investigator of several clinical trials dedicated to colorectal cancers.

Dr. Cohen commented, “After they have received the main standard of care treatments, patients with metastatic colorectal cancer have limited options for more efficacious treatment and as a result have poor clinical outcomes. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO4010 in this frequent and underserved indication and providing updates on the progress of the AUDREY study.”

Pierre Bélichard, Chief Executive Officer of Enterome, added, “This new trial evaluating EO4010 in patients with advanced disease of colorectal cancer is another significant milestone for Enterome. Building on the promising data from our ongoing trials investigating EO2401 in recurrent glioblastoma and adrenal tumors, and EO2463 in non-Hodgkin lymphoma, we believe that our upcoming studies with EO4010 and EO2040 in colorectal cancer will reinforce Enterome's position as a leader in next-generation cancer immunotherapies. Through our OncoMimics™ immunotherapies, we are able to break the immune tolerance to self-antigens with a technology that is off-the-shelf and enables multi-targeting of tumor antigens. This groundbreaking approach so far demonstrates both efficacy and safety for the patients, instilling real hope in the fight against cancer.”