Paris, France | July 21, 2026
Enterome SA announced positive interim Phase 1/2 clinical data from its ongoing SIDNEY trial, demonstrating that treatment with its OncoMimics™ immunotherapy candidate EO2463 induced CD8 T-cell expansion that was statistically significantly associated with longer progression-free survival (PFS) in patients with indolent non-Hodgkin lymphoma (iNHL) managed under a watch-and-wait strategy. The company also reported that EO2463-induced CD8 T-cell expansion was significantly associated with complete response rates in patients with relapsed or refractory iNHL receiving the investigational therapy in combination with lenalidomide and rituximab (R²). The findings, presented at the Pan Pacific Lymphoma Conference (PPLC), strengthen evidence supporting EO2463-induced CD8 T-cell expansion as a potential predictive biomarker for clinical benefit while reinforcing the therapy’s potential to become a first-in-class immunotherapy for patients with indolent B-cell lymphomas. Based on the encouraging results, Enterome is preparing EO2463 for the final stage of registrational clinical development while pursuing strategic partnerships to accelerate commercialization.
EO2463 Demonstrates Promising Clinical Activity Across Multiple Patient Populations
The ongoing SIDNEY (NCT04669171) Phase 1/2 study is evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 both as a monotherapy and in combination with established lymphoma treatments across several patient populations, including follicular lymphoma and margininal zone lymphoma. Newly presented analyses showed that patients in the watch-and-wait monotherapy cohort who experienced greater EO2463-induced CD8 T-cell expansion achieved significantly longer progression-free survival with a hazard ratio of 0.18 and a statistically significant log-rank p-value of 0.020. In patients with relapsed or refractory disease receiving EO2463 together with lenalidomide and rituximab, higher CD8 T-cell expansion also correlated significantly with complete response rates (p=0.0073). These findings build upon previously reported clinical results, including a 46% objective response rate observed in watch-and-wait patients and higher-than-expected complete response rates in combination therapy presented at previous scientific congresses.
OncoMimics Platform Targets Multiple B-Cell Markers to Enhance Immune Response
EO2463 is an off-the-shelf active immunotherapy developed using Enterome’s proprietary OncoMimics™ platform, which employs synthetic bacteria-derived peptides engineered to mimic multiple B-cell lineage markers, including CD20, CD22, CD37, and CD268 (BAFF receptor), together with the helper peptide UCP2. This multi-target approach is designed to stimulate rapid expansion of pre-existing effector-memory CD8 T cells, enabling the immune system to selectively recognize and eliminate malignant B cells while minimizing the risk of tumor antigen escape. Unlike many personalized immunotherapies, OncoMimics products are manufactured as off-the-shelf therapeutics, offering the potential for broader patient access and simplified clinical implementation. Earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to EO2463 for the treatment of follicular lymphoma, further supporting its regulatory development pathway.
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Positive Biomarker Data Support Registrational Development and Pipeline Expansion
According to Pierre Belichard, Chief Executive Officer of Enterome, the newly reported correlation between EO2463-induced CD8 T-cell expansion and progression-free survival represents an important milestone that supports advancing the program into registrational clinical development for patients with indolent non-Hodgkin lymphoma, particularly those managed under the watch-and-wait approach, where no active treatment is currently available despite the significant psychological burden associated with a cancer diagnosis. The company believes EO2463 has the potential to extend progression-free survival while maintaining a favorable tolerability profile in an often older and medically fragile patient population. Beyond lymphoma, Enterome continues to expand its OncoMimics™ oncology pipeline and announced that it will present new data on its solid-tumor immunotherapy candidate EO4010 at the European Society for Medical Oncology (ESMO) Congress 2026, highlighting CD8 T-cell expansion and survival outcomes in patients with mismatch repair proficient metastatic colorectal cancer. Together, these advances reinforce Enterome’s strategy to develop multi-target immune therapies capable of generating durable anti-tumor responses across a broad range of cancers while positioning EO2463 as a promising next-generation immunotherapy for B-cell lymphoma.
Source: Enterome press release
