PRESS RELEASE
- Magnitude of EO2463-induced CD8 T-cell expansion during monotherapy statistically significantly associated with longer progression-free survival (PFS) in patients with indolent non-Hodgkin lymphoma (iNHL) managed in the watch-and-wait setting
- EO2463-induced CD8 T-cell expansion also statistically significantly associated with complete response rate in patients with relapsed/refractory iNHL treated with EO2463 in combination with lenalidomide and rituximab (R²)
- Findings support EO2463-induced CD8 T-cell expansion as a potential predictive biomarker for clinical benefit
- Data presented at Pan Pacific Lymphoma Conference (PPLC)
- Enterome will also present data on its solid-tumor OncoMimics™ candidate EO4010 at the European Society for Medical Oncology (ESMO) Congress 2026
Paris, France – 21 July 2026
Enterome SA, a clinical-stage company pioneering OncoMimics™, a new class of off-the-shelf, multi-targeted in vivo immune therapies, today announced new positive interim data from the ongoing open-label Phase 1/2 SIDNEY trial of OncoMimics™ EO2463 to treat indolent Non-Hodgkin Lymphoma (iNHL). The data show EO2463 continues to have an effect, now showing a statistically significant correlation with progression-free survival (PFS) as a monotherapy in the watch-and-wait setting, and an additive effect, associated with complete response rates, when used in a triple combination, together with the standard of care, lenalidomide and rituximab (R2).
These new findings confirm previous data suggesting specific CD8 T cell expansion caused by EO2463 could be developed as a predictive biomarker and represent a compelling rationale for further study to confirm that EO2463 increases PFS in patients with iNHL.
Enterome presented the data today at the Pan Pacific Lymphoma Conference (PPLC) at the Fairmont Orchid, Kohala Coast (Big Island) in Hawaii. Copy of the poster is available here.
“The correlation between the robust CD8 T cell expansion induced by EO2463 and PFS is a landmark finding that creates an imperative for further study and offers new hope for patients suffering from iNHL. It suggests that EO2463, which has been well-tolerated to date, may effectively extend PFS as a standalone therapy without hurting quality of life in this generally older and fragile patient population. We want to prioritize patients classified for watch-and-wait, an observational protocol, because they currently receive no active treatment, despite having to live with the grave psychological impact of their cancer diagnosis,” said Pierre Belichard, Chief Executive Officer of Enterome. “Based on these and other data, we believe EO2463 is ready to start the final stage of registrational clinical development as a first-in-class therapeutic for patients with iNHL in a watch-and-wait setting. We are in active discussions with potential investors and partners to find the best way to bring this product to patients.”
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.
More recently, as SIDNEY progresses, data have begun to show the impact of EO2463 on clinical efficacy. Enterome reported at ASH in late 2025 that EO2463 caused a higher-than-expected complete recovery (CR) rate with the triple combination therapy, EO2463 and R2, compared to the combination of only lenalidomide and rituximab (or “R2”). Data reported at ASH in late 2024 showed that EO2463 monotherapy generated a 46% objective response rate in watch-and-wait patients.
Last month, at EHA 2026, Enterome presented data showing that EO2463-induced CD8 T cell expansions were significantly associated with clinical outcomes in each of the monotherapy, rituximab (“R1”), and R2 cohorts, suggesting that EO2463-induced CD8 T-cell expansion can be used as a predictive biomarker. Today, Enterome announced that new analyses extend this finding to progression-free survival in the monotherapy cohort.
Key data presented at PPLC:
- In the EO2463 monotherapy cohort (Cohort 2, watch-and-wait), higher CD8 T cell expansion was significantly associated with longer progression-free survival (HR=0.18, 95% CI 0.03–0.82; log-rank p=0.020).
- In the EO2463 plus lenalidomide/rituximab combination cohort (Cohort 1+4, relapsed/refractory disease), higher CD8 T cell expansion was significantly associated with complete response (p=0.0073)
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 pre-existing memory CD8 T cells, selectively target 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.
Upcoming presentation at ESMO Congress 2026
Enterome will also present data on its solid-tumor OncoMimics™ candidate EO4010 at the European Society for Medical Oncology (ESMO) Congress 2026, taking place 23–27 October 2026 in Madrid, Spain.
Title: EO4010 (EO) multi-target peptide immunotherapy: tumor directed CD8 T cell expansion kinetics and association to survival in patients (pts) with treated mismatch repair proficient (pMMR) metastatic colorectal carcinoma (mCRC)
Presentation number: 859P
Presentation time: Sun, October 25, 2026 – Time: 12:00 - 12:45
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.
For more information, please contact:
ENTEROME
Pierre Belichard
Chief Executive Officer
communication@enterome.com
INVESTOR & MEDIA RELATIONS
Chris Maggos / Giovanni Ca’ Zorzi
+41 (0)79 367 6254 / +33 (0)7 84 67 07 27
enterome@cohesionbureau.com
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