On November 16, 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 efficacy, immunogenicity and safety 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 at the 27th Society for Neuro-Oncology (SNO) Annual Meeting which will be held in Tampa Bay, Florida, US on November 16-20, 2022 (Press release, Enterome, NOV 16, 2022, View Source [SID1234624181]).
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The abstract is published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, and available 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.
Promising data presented during 2022 at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), EANO and SITC (Free SITC 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, either as a low-dose symptom driven time-limited treatment, or as a continuous treatment at the labelled US dose, to EO2401 in combination with nivolumab supported longer treatment durations and an increase in efficacy.
CD8+ T cells against at least one of the EO2401 peptides was detected in 26 out of 28 patients with some patients exhibiting up to 5% of circulating specific CD8+ T cells. Memory specific CD8+ T cells response were found as early as two weeks after the first vaccination and maintenance of a strong and stable immune response could be detected for more than 10 months.
Additional patients are to be treated with triple combination of EO2401/nivolumab/bevacizumab to support final regimen selection for further studies.
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.