On June 2, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported it will present positive data from its Phase 1/2 clinical study with EO2463, its lead clinical program, as monotherapy and in combination with lenalidomide and/or rituximab to treat indolent Non-Hodgkin lymphoma (iNHL) at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21, 2025 (Press release, Enterome, JUN 2, 2025, View Source [SID1234653605]).

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As indicated by the data generated by Enterome’s ongoing SIDNEY study, EO2463 has the potential to become a frontline therapy in iNHL, either as monotherapy or in combination regimens, across all patient groups suffering from the disease, including in watch-and-wait settings, first-line therapy, and in relapsed/refractory settings.

The title of the peer-reviewed presentation is "EO2463 (EO) peptide immunotherapy in combination with lenalidomide (L) and rituximab (R) in patients (pts) with follicular (FL) and marginal zone lymphoma (MZL)", and will be presented by Dr Jose Caetano (JC) Villasboas Bisneto, principal study investigator at the Mayo Clinic in Rochester, MN, USA.

"We look forward to sharing these interim Phase 2 data, which suggest to us that our lead OncoMimics immunotherapeutic candidate EO2463 could have broad potential to benefit patients suffering from multiple clinical presentations of Follicular Lymphoma. Later this month, Dr Villasboas will present interim data obtained more specifically in iNHL patients with relapsed/refractory disease," said Pierre Bélichard, Chief Executive Officer of Enterome.

"Just this past weekend we presented positive Phase 1/2 data from the AUDREY trial in metastatic colorectal cancer with our second-most advanced OncoMimics immunotherapeutic candidate, EO4010, at ASCO (Free ASCO Whitepaper). OncoMimics represent a new therapeutic modality that has tremendous potential for cancer treatment."

Separately, Enterome recently held a positive Type-C meeting with the FDA, outlining a clear regulatory path to marketing approval for EO2463 in iNHL after constructive discussion with the regulator.

In addition, this week, Enterome will participate at the Jefferies Global Healthcare Conference in New York ( June 3 to 5). Pierre Bélichard and Chief Financial Officer Christelle Dumoussaud will meet with investors and industry partners during the event.

SIDNEY is a 12-month open label study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in some 48 patients with follicular lymphoma and marginal zone lymphoma. The study is comprised of four cohorts: 1) relapsed/refractory iNHL patients, who received EO2463 monotherapy for 6 weeks, followed by combination with lenalidomide plus rituximab for 16 weeks; 2) EO2463 monotherapy in newly diagnosed untreated stage III/IV iNHL classified as "watch and wait"; 3) EO2463 monotherapy followed by combination with rituximab in newly diagnosed previously untreated stage III/IV iNHL patients classified with low tumor burden in need of therapy; 4) relapsed/refractory iNHL patients, having received at least one prior treatment. EO2463 and lenalidomide are given in combination from treatment inception with addition of rituximab at week 19.

Enterome has previously presented interim data from the study at major international conferences held by the European Hematology Association (EHA) (Free EHA Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper), and the American Society for Cancer and Oncology.

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. 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 such as antigen escape.