Enterome Reports Positive Phase 2 Data for EO2463 in Indolent Non-Hodgkin Lymphoma
Key Insights
Enterome will present positive Phase 2 data for EO2463, its lead OncoMimics immunotherapy, in treating indolent non-Hodgkin lymphoma (search) at the International Conference on Malignant Lymphoma on June 21, 2025.
The SIDNEY study demonstrates EO2463's potential as a frontline therapy across multiple patient groups, including watch-and-wait, first-line, and relapsed/refractory settings.
Enterome recently held a positive Type-C meeting with the FDA, establishing a clear regulatory pathway to marketing approval for EO2463 in indolent non-Hodgkin lymphoma (search).
Enterome SA will present positive Phase 2 data for its lead OncoMimics immunotherapy EO2463 in treating indolent non-Hodgkin lymphoma (search) (iNHL) at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21, 2025. The clinical-stage biopharmaceutical company's presentation will showcase interim results from the ongoing SIDNEY study, demonstrating the therapy's potential across multiple patient populations.
SIDNEY Study Design and Patient Population
The SIDNEY study is a 12-month open-label Phase 2 trial evaluating EO2463 as monotherapy and in combination with lenalidomide and/or rituximab in 48 patients with follicular lymphoma (search) and marginal zone lymphoma (search). The study comprises four distinct cohorts targeting different patient populations:
The first cohort includes relapsed/refractory iNHL patients who receive EO2463 monotherapy for 6 weeks, followed by combination therapy with lenalidomide plus rituximab for 16 weeks. The second cohort evaluates EO2463 monotherapy in newly diagnosed untreated stage III/IV iNHL patients classified as "watch and wait." The third cohort examines EO2463 monotherapy followed by combination with rituximab in newly diagnosed previously untreated stage III/IV iNHL patients with low tumor burden requiring therapy. The fourth cohort studies relapsed/refractory iNHL patients who have received at least one prior treatment, with EO2463 and lenalidomide given in combination from treatment inception and rituximab added at week 19.
Broad Therapeutic Potential Demonstrated
According to Pierre Bélichard, Chief Executive Officer of Enterome, the interim Phase 2 data suggest that EO2463 "could have broad potential to benefit patients suffering from multiple clinical presentations of Follicular Lymphoma (search)." The data generated by the ongoing SIDNEY study indicate that 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.
Dr. Jose Caetano Villasboas Bisneto, principal study investigator at the Mayo Clinic in Rochester, Minnesota, will present the peer-reviewed data titled "EO2463 (EO) peptide immunotherapy in combination with lenalidomide (L) and rituximab (R) in patients (pts) with follicular (FL) and marginal zone lymphoma (search) (MZL)."
Regulatory Progress and FDA Engagement
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. This regulatory milestone represents significant progress toward potential commercialization of the therapy.
The company has previously presented interim data from the SIDNEY study at major international conferences held by the European Hematology Association, the American Society of Hematology, and the American Society for Cancer and Oncology.
Novel OncoMimics Technology Platform
EO2463 represents 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 (search), CD22 (search), CD37 (search), and CD268 (search) (BAFF receptor (search)). 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.
Broader Pipeline Development
Bélichard noted that the company recently presented positive Phase 1/2 data from the AUDREY trial in metastatic colorectal cancer (search) with EO4010, their second-most advanced OncoMimics immunotherapeutic candidate, at ASCO. "OncoMimics represent a new therapeutic modality that has tremendous potential for cancer treatment," he stated.
Enterome's pioneering approach to drug discovery is based on the unique and powerful bacterial Mimicry drug discovery platform, which allows it to discover OncoMimics with high similarity to tumor associated antigen (TAA) based on big-data insights from millions of gut bacterial proteins that live in humans. The three most advanced product candidates have shown positive early data in Phase 2 clinical development, supporting the novel OncoMimics modality.