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InscriptionEO2401 is a first-in-class OncoMimics™ peptide-based immunotherapy able to rapidly activate and significantly expand existing effector memory CD8+ T cells against tumor-associated driver antigens due to their strong cross-reactivity with OncoMimics™ peptides
Paris, France – December 12, 2022
Enterome, a clinical stage company developing first-in-class immunomodulatory drugs based on its gut bacterial Mimicry drug discovery platform, today announces completion of patient enrollment in its Phase 2 clinical trial (ROSALIE) evaluating its lead OncoMimics™ candidate, EO2401, in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab) in patients with first progression/recurrence of glioblastoma, an aggressive form of brain cancer.
The Phase 2 trial (NCT04116658) is an open-label, multicenter study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2401. A total of 100 patients have started treatment in the different study cohorts at 10 clinical sites in Europe and the US. Initial and highly promising immunological and clinical results were obtained in 2022 and presented at leading clinical oncology meetings during 2022.
Prof. David Reardon, MD, Clinical Director for Dana-Farber Cancer Institute, discussed the key takeaways from the ROSALIE study on The ASCO Post. The video can be viewed here.
OncoMimics™ immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs) expressed on tumoral cells, resulting in a rapid targeted cytotoxic response against cancer.
EO2401 combines three OncoMimics™ peptides mimicking IL13Ra2, BIRC5 and FOXM1, TAAs present in aggressive cancers such as glioblastoma, combined with the helper peptide UCP2 (Universal Cancer Peptide 2).
“The completion of enrollment in ROSALIE moves us one step closer to establishing OncoMimics™ immunotherapies as potential breakthrough drugs for treating aggressive forms of cancer, resisting today’s most effective treatments, in broad patient populations,” said Pierre Bélichard, co-founder and Chief Executive Officer of Enterome. “Thanks to the eagerness and dedication among global investigators, and an impressive effort from our team, we were able to enroll 100 patients within the projected timeframe. I consider it a remarkable achievement for the first immune-oncology study ever sponsored and conducted by Enterome. We extend our sincere thanks to the patients, caregivers, clinical investigators and staff who are participating in the ROSALIE trial, and we look forward to presenting further results in 2023.”
Key highlights from the Phase 2 ROSALIE trial presented during 2022 were:
Clinical and immunological data from ROSALIE have been presented at five different scientific meetings in 2022: ASCO, ESMO, EANO, SITC and SNO. Further updates on the trial were presented last week at the ESMO IO Annual Congress which took place in Geneva (Switzerland).
Materials from scientific presentations can be found under ‘Posters’ on Enterome’s website.
About EO2401
EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics™ peptide-based immunotherapy. It combines three microbial-derived OncoMimics™ peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5 and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). EO2041 is designed to trigger the immune system into recognizing these epitopes on glioblastoma cells as foreign (non-self) and eliciting a targeted memory T-cell driven cell-killing response against the tumor cells.
