PARIS, Sept. 16, 2022 /PRNewswire/ — Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces that an oral presentation of its Phase 1/2 clinical trial of EO2401 in patients with first progression/recurrence of glioblastoma (ROSALIE trial), will be made at the European Association of Neuro-Oncology (EANO) Meeting 2022 (Vienna, Austria) in the Award Winning Abstracts session on Saturday, September 17 at 16:00 CEST (full details below) by Professor Ahmed Idbaih, Sorbonne University, AP-HP La Pitié-Salpêtrière & Paris Brain Institute (Paris, France) and a clinical investigator in the ROSALIE trial.
EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics™ cancer immunotherapy. It combines three OncoMimics™ peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, which are known driver antigens present on aggressive solid tumors. In addition, EO2401 contains a CD4 helper peptide UCP2. Enterome selected these OncoMimics™ peptides using its Mimicry platform, which applies best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 20+ million bioactive gut microbiome peptides and proteins.
Professor Ahmed Idbaih, said, “Immunotherapies have dramatically improved the prognosis of multiple cancers. At EANO we will be presenting our promising results with a new highly innovative immunotherapy, the OncoMimics™-based therapeutic cancer vaccine EO2401 in combination with nivolumab and/or bevacizumab in patients with glioblastoma. We are delighted to have this opportunity to share our findings with the neuro-oncology community at this prestigious meeting.”
Highlights from the EO2401/ ROSALIE Phase 1/2 trial:
- Data published to date confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab.
- 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 – 55% vs. 10%), disease control rate (DCR – 82% vs. 34%), and progression-free survival (PFS – 5.5 months vs 1.8 months), with 3 of the first 11 patients showing complete remission.
Details on Enterome’s oral presentation at EANO (ROSALIE study)
Title: A novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma: ROSALIE STUDY
Presenter: Prof Ahmed IDBAIH, France
Abstract number: PL02. 1.A
Session: PL02 Award Winning Abstracts
Date: Saturday September 17, 2022 at 16:00 CEST
The abstract has been published in the Official Journal of the Society for Neuro-Oncology and can be viewed here.
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.
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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 therapeutic cancer vaccines. 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 based on FOXM1 & BIRC5 mimics and will start a Phase 2 trial in Q3 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