EO2401 is a first-in-class OncoMimics™ peptide-based immunotherapy able to significantly activate and expand existing effector memory CD8+ T cells directed at OncoMimics™ peptides with strong cross-reactivity against tumor-associated driver antigens

Paris, France – November 7, 2022

Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces it will present updated safety, immunogencity and efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (ROSALIE trial) in an oral presentation and a poster presentation at the 37^th Society for Immunotherapy of Cancer (SITC) Annual Meeting which will be held both virtually and in person in Boston, MA, USA on November 10-12, 2022.

Oral Presentation Details – Abstract #642

• Title: EO2401 microbiome derived therapeutic vaccine + nivolumab, with/without standard continuous, or low-dose symptom directed, bevacizumab, in recurrent glioblastoma: phase 1-2 EOGBM1-18/ROSALIE study
• Authors: D. Reardon et al.
• Date: November 10, 2022
• Time: 12:03 p.m. EST
• Location: Boston Convention and Exhibition Center, Ballroom West, Concurrent Session 105
• Presenter: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School and Clinical Director for Dana Farber Cancer Institute

Poster Presentation Details – Abstract #641

• Title: Strong immune response to therapeutic vaccination with EO2401 microbiome derived therapeutic vaccine + nivolumab: interim report of the EOGBM1-18/ROSALIE study
• Authors: A. Maia et al.
• Date: November 10, 2022
• Location: Boston Convention and Exhibition Center, Hall C
• Presenter: Dr Ana Maia, Tübingen University Hospital, Interfaculty Institute for Cell Biology (“IFIZ”)

The abstracts will be published at 8 a.m. EST on November 7, 2022 in a supplement to The Journal for ImmunoTherapy of Cancer (JITC) and via this link.

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.

About ROSALIE

ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.

Promising data presented during 2022 at ASCO and ESMO

• Data confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
• EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
• Addition of bevacizumab to EO2401 and nivolumab supported longer treatment durations, and an increase of objective response rate (ORR – 54.5% vs. 10.3%), disease control rate (DCR – 81.8% vs. 34.5%), and progression-free survival (PFS – 5.5 months vs 1.8 months), with 3 out of the first 11 patients showing complete remission.
• Additional patients are to be treated with triple combination of EO2401/nivolumab/bevacizumab to support final regimen selection for further studies.

 

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