Enterome announces presentation of data from ongoing Phase 1/2 trial of its peptide-based immunotherapy EO2401 in recurrent glioblastoma (ROSALIE study) at SNO 2022

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

PARIS, Nov. 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 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.

Oral Presentation Details – Abstract CTIM-17

Title:                 EO2401 therapeutic vaccine for patients with recurrent glioblastoma: phase 1/2 ROSALIE study (NCT04116658)
Authors:           D. Reardon et al.
Date:                November 18, 2022
Time:                4:35 pm EST
Location:          Tampa Convention Center, Ballroom B
Presenter:        Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School, and Clinical Director for Dana Farber Cancer Institute

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, ESMO, EANO and SITC

• 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.

Contacts

About Enterome

Enterome is a clinical-stage biopharmaceutical company 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 it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Its 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.

The company's two pipelines of drug candidates include: 

-  OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. Lead candidate, EO2401, is in Phase 1/2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. EO2463 is in a Phase 1/2 clinical trial for indolent non-Hodgkin lymphomas, with clinical proof-of-concept data expected in H1 2023. EO2040, a new immune therapy, is expected to start a Phase 2 trial by year end 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, are being developed in collaboration with Nestlé Health Science, for the treatment of immune diseases. Lead candidate, EB1010, expected to enter the clinic in 2023, is a potent local inducer of IL-10, designed to improve therapeutic outcomes for patients with inflammatory bowel disease (IBD).

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