On November 7, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported 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 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting which will be held both virtually and in person in Boston, MA, USA on November 10-12, 2022 (Press release, Enterome, NOV 7, 2022, View Source [SID1234623191]).
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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 (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper)
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.