EO4010 is the company’s third OncoMimics candidate, for the treatment of patients with unresectable, previously treated, metastatic colorectal cancer (CRC).
The drug 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.
Enterome’s latest study 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.
It 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 and coordinating investigator for the trial, said: “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, CEO 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.”