Enterome Showcases High Response Rate in EO2463 Study for Indolent Non-Hodgkin Lymphoma at ASCO 2024

Enterome, a Paris-based clinical-stage biopharmaceutical company, has unveiled encouraging interim results from its ongoing Phase 1/2 SIDNEY (EONHL1-20) trial. This study assesses the safety and efficacy of EO2463, both as a standalone treatment and in combination with lenalidomide and/or rituximab, for patients with indolent non-Hodgkin lymphoma (NHL). The findings were shared during a poster session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Impressive Clinical Outcomes

The EO2463 monotherapy demonstrated beneficial clinical responses as early as six weeks into the treatment, with a notable complete response rate of 78% when combined with lenalidomide and/or rituximab. This substantial response rate underscores the potential of EO2463 in significantly improving patient care for those suffering from NHL.

Mechanism and Immune Response

EO2463 has shown a remarkable capability to rapidly expand memory CD8+ T cells specific to OncoMimics™ peptides and B cell antigens. This expansion leads to a robust cytotoxic response that can persist for up to 94 weeks, offering long-term benefits. The therapy was well-tolerated, with no severe adverse events related to the treatment. The most common side effects were limited to local administration site reactions and headaches.

Study Design and Initial Results

The Phase 1/2 EONHL1-20/SIDNEY trial involves multiple treatment regimens. Patients in the initial cohort received EO2463 every two weeks for four doses, followed by a dose every four weeks for up to 15 doses. After six weeks, lenalidomide was added, and if a complete remission was not achieved by week 19, rituximab was introduced.

At the six-week mark of EO2463 monotherapy, metabolic markers and tumor size reductions were observed in 44% of patients. Upon combining EO2463 with lenalidomide and/or rituximab, a complete response was seen in 78% of patients, with 56% achieving radiologic complete responses.

Future Directions

Encouraged by these results, Enterome plans to continue the SIDNEY trial, focusing on additional cohorts. These include:
- EO2463 monotherapy in newly diagnosed, previously untreated follicular lymphoma (FL) or marginal zone lymphoma (MZL) patients in a "watch-and-wait" scenario.
- EO2463 combined with rituximab from week seven in newly diagnosed, previously untreated FL/MZL patients needing therapy.
- EO2463, lenalidomide from week one, and rituximab from week 19 in patients with relapsed or refractory, previously treated FL/MZL.

EO2463's Unique Approach

EO2463 is a trailblazing immunotherapy candidate that combines four synthetic OncoMimic™ peptides. These peptides mimic B lymphocyte-specific markers, allowing EO2463 to target and destroy malignant B lymphocytes effectively. This innovative approach ensures extensive coverage of malignant B cells while minimizing the impact on normal peripheral B cells.

Conclusion

The promising interim results from the SIDNEY trial highlight EO2463's potential as a significant therapeutic option for indolent non-Hodgkin lymphoma. With its robust and sustained immune response, high complete response rates, and favorable safety profile, EO2463 could offer a new hope for patients who currently have limited treatment options. Enterome's ongoing research and future trials will be crucial in confirming these early findings and potentially paving the way for EO2463's use in broader clinical settings.

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