Enterome presents Phase 1/2 iNHL interim data at EHA demonstrating durable OncoMimics™-induced CD8 T cell responses and clinical activity

PRESS RELEASE

• EO2463 was well tolerated in monotherapy and in R² combination therapy cohorts
• EO2463-induced CD8 T cell expansion significantly associated with clinical response across cohorts
• Data support development of EO2463-induced immune response as a predictive biomarker
• OncoMimics™ induced a rapid, durable CD8 T-cell expansion characterized by an effector memory phenotype that cross-reacted with B-cell blood cancer lineage markers

Paris, France – 15 June 2026

Enterome SA, a clinical-stage company pioneering OncoMimics™, a new class of off-the-shelf, multi-targeted immune therapies to expand specific CD8 T-cells in vivo, today presented new interim data from the ongoing Phase 1/2 SIDNEY study of OncoMimics™ EO2463 in patients with indolent non-Hodgkin lymphoma (iNHL). The data are being presented at the European Hematology Association (EHA) 2026 Congress in Stockholm (Abstract PF938, Poster Session 1).

SIDNEY is a multi-cohort study evaluating EO2463 as monotherapy in patients who are previously untreated and having low-tumor-burden disease suitable for watchful waiting (Cohort 2; N=25), in combination with rituximab in patients previously untreated with low-tumor burden disease requiring treatment (Cohort 3; N=6), and in combination with lenalidomide plus rituximab (R²) in patients with relapsed/refractory (Cohorts 1+4; N=23). EO2463 continued to be well tolerated across all settings.

Positive immune responses were confirmed in 43 of 48 tested patients (90%). EO2463 rapidly induced expansion of EO2463-mimic and B cell target peptide-specific CD8 T cells, predominantly displaying an effector memory phenotype cross-reactive with cancerous B-cell lineage markers. Responses were durable, with specific CD8 T cells detectable up to 34 months after the last EO2463 administration.

EO2463 demonstrated clinical activity across treatment settings. As monotherapy in patients who are usually recommended watchful waiting, EO2463 produced a 41% objective response rate (ORR) (Lugano criteria). Patients receiving EO2463 plus R² combination achieved a 74% ORR, and 61% complete response rate, with a median duration of objective response of 35.2 months.

Importantly, EO2463-induced CD8 T cell expansions were significantly associated with objective response on EO2463 monotherapy and complete responses on EO2463 in combination with R², suggesting that the EO2463 treatment and mechanism of action is linked to the clinical outcome in both settings. The data show that, on EO2463 monotherapy, higher early expansion was statistically significantly associated with objective response. These data also support development of a predictive biomarker based on the EO2463-induced immune responses.

“The EHA data demonstrate that EO2463 consistently induces rapid and durable expansions of CD8 T cells against the B-cell lineage markers targeted by EO2463 while having a favorable tolerability profile. The significant association between expansion of specific CD8 T cells and objective responses both for EO2463 monotherapy and EO2463 in combination with standard of care supports continued development of EO2463 as a novel immunotherapy for B cell lymphomas,” said Jan Fagerberg, MD, Chief Medical Officer of Enterome.

“These data confirm EO2463’s unique profile as an off-the-shelf immunotherapy that generates rapid, durable and clinically meaningful immune responses across treatment settings. Patients in the watch-and-wait setting currently receive no active treatment despite the psychological burden of their diagnosis. We believe EO2463 could change that paradigm and are actively seeking partners and investors to advance its registrational development,” said Pierre Belichard, Chief Executive Officer of Enterome.

Updated data from the ongoing SIDNEY trial will also be presented at the Pan Pacific Lymphoma Conference (PPLC) in Hawaii (July 20–24, 2026). Enterome will attend the BIO International Convention 2026 in San Diego (June 22–25).

EHA 2026 Presentation Details

Title: EO2463 an off-the-shelf multi-target peptide immunotherapy: in vivo CD8 T cell expansion kinetics correlates with efficacy in patients with follicular (FL) and marginal zone (MZL) lymphoma. Study EONHL1-20/SIDNEY (NCT04669171)
Abstract: PF938 | Poster Session 1, Friday June 12, 2026
European Hematology Association Congress 2026, Stockholm, Sweden
Poster viewing: 08:00–18:45 CEST | Presenter-attended session: 18:45–19:45 CEST

SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R². Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies.

EO2463 is an off-the-shelf OncoMimics™ active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand in vivo pre-existing memory CD8 T cells, selectively targeting malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma.

OncoMimics™ consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics™ help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics™ peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention. 

Enterome SA (www.enterome.com) is a privately held clinical-stage biopharmaceutical company developing breakthrough OncoMimics™ immunotherapeutics for cancer. The three most advanced product candidates have shown positive early data in Phase 2 clinical development, supporting the novel OncoMimics™ modality. The company’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 antigens (TAA) based on the big-data insights from millions of gut bacterial proteins that live in humans. 

 
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Attachment

• 2026-06-15 Enterome PR EHA poster_FINAL

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