Enterome to present updated safety, immunogenicity and efficacy data from its Phase 1/2 trial of EO2401 in recurrent glioblastoma (ROSALIE study) at SITC 2022

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, Nov. 7, 2022 /PRNewswire/ -- 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 The Journal for ImmunoTherapy of Cancer (JITC) supplement 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.

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.

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.

Contacts

About Enterome

Enterome is a clinical-stage biopharmaceutical company focused on developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome's pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform allowing to uncover new biological insights from millions of gut bacteria proteins in constant cross-talk with the human body.

Enterome's potentially first-in-class small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines.

Enterome is presently advancing two pipelines of drug candidates, OncoMimics™ and EndoMimics™, which have the potential to address cancer, inflammatory and autoimmune diseases, respectively:

• OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. The lead candidate EO2401 is in Phase 1/2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. A second OncoMimics™ candidate, EO2463 is in a Phase 1/2 clinical trial for indolent non-Hodgkin lymphomas. Clinical proof-of-concept data are expected in H1 2023. EO2040 is a new immune therapy expected to start a Phase 2 trial in Q4 2022 in patients suffering from colorectal cancer with ctDNA-defined, minimal residual disease. EO4010 is in development for third-line colorectal cancer and targeted to enter clinical trials in 2023.
• EndoMimics™ peptides, a pipeline of next generation bioactives acting like human hormones or cytokines for the treatment of immune diseases. EB1010, the lead candidate, is a potent local inducer of IL-10 designed to provide improved therapeutic outcomes for patients with IBD. EB1010 is expected to enter the clinic in 2023. EndoMimics™ pipeline and EB1010 are being developed in collaboration with Nestlé Health Science.

Enterome employs 70 people and is headquartered in Paris, France. Since its inception, the company has raised a total of €116 million from Europe- and US-based life science investors and more than €100 million from pharmaceutical partnerships.

For more information, please visit the company's website at: www.enterome.com