• Two poster presentations to feature novel data from the Phase 1/2 SIDNEY trial of EO2463 in indolent Non-Hodgkin Lymphoma (iNHL), highlighting initial data from Cohort 2 as monotherapy in a “watch-and-wait” setting, and findings on a predictive biomarker for treatment response

Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, today announced that clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, an experimental treatment for indolent non-Hodgkin B-cell lymphoma (iNHL), will be presented at the 66^th American Society of Hematology (ASH) Annual Meeting and Conference, to take place December 7-10, 2024, in San Diego, California, and online.

These presentations will disclose the first data from Phase 2 Cohort 2, evaluating EO2463 as monotherapy for newly diagnosed patients with asymptomatic follicular lymphoma, where EO2463 may offer a safe, proactive immune therapy alternative to the usual “watch-and-wait” observation strategy. The data also report initial findings on a biomarker with potential to predict long-term response to EO2463, both as monotherapy, and in combination with standard treatments, in relapsed/refractory iNHL.

Details of the poster presentations are as follows:

Abstract #1616

• Title: EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab
• Presenting Author: Dr. J.C. C. Villasboas Bisneto, M.D., Mayo Clinic
• Session: 622. Lymphomas: Translational – Non-Genetic: Poster I
• Session Date: Saturday, December 7, 2024
• Presentation Time: 5:30 PM - 7:30 PM

Abstract #4395

• Title: EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
• Presenting Author: Dr. Stephen Smith, M.D., Associate Professor, UW Medicine & Fred Hutchinson Cancer Center
• Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
• Session Date: Monday, December 9, 2024
• Presentation Time: 6:00 PM - 8:00 PM

SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

For more information on the study, visit www.Clinicaltrials.gov, reference: NCT04669171.

About EO2463:
EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms.

Contacts

About Enterome

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

Enterome’s first-in-class drug candidates are based on synthetically produced, commensal-derived peptides that modulate the immune system by closely mimicking the structure of specific antigens.

The company’s oncology pipeline includes the following OncoMimics™ peptide-based immunotherapies:

• EO2463, currently in the Phase 2 ‘SIDNEY’ clinical trial for indolent non-Hodgkin lymphomas, has shown a favorable safety profile with promising early signs of efficacy;
• EO2401, administered in combination with nivolumab and bevacizumab, has demonstrated clinical activity in approximately one-third of patients with recurring glioblastoma in the completed Phase 1/2 ‘ROSALIE’ study;
• EO4010 is being evaluated in metastatic colorectal cancer in the Phase 1/2 ‘AUDREY’ study.

Enterome is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors, and more than €100 million through pharmaceutical partnerships.

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