Enterome's EO2463 Shows Promising CD8 T-Cell Expansion in Phase 2 Indolent Non-Hodgkin Lymphoma Trial
核心洞察
Enterome's OncoMimics (搜索)™ immunotherapy EO2463 rapidly induced extensive in vivo expansion of B cell target-specific CD8 T-cells in the ongoing SIDNEY Phase 2 trial for indolent non-Hodgkin lymphoma (搜索).
The study established a correlation between EO2463-induced CD8 T-cell expansions and Lugano objective response, suggesting potential for these measures as predictive biomarkers.
EO2463 demonstrated robust tumor-specific immunogenic activity and clear monotherapy objective responses, with the company actively pursuing regulatory pathways for Phase 3 development.
Enterome SA has presented encouraging interim data from its SIDNEY Phase 2 trial showing that EO2463, an innovative OncoMimics (搜索)™ immunotherapy, rapidly induced extensive in vivo expansion of B cell target-specific CD8 T-cells in patients with indolent non-Hodgkin lymphoma (搜索) (NHL). The data, presented at the European Hematology Association (EHA) Congress in June 2026, demonstrated a correlation between EO2463-induced CD8 T-cell expansions and objective tumor responses.
Novel Immunotherapy Mechanism Shows Clinical Promise
The SIDNEY Phase 2 trial results revealed that EO2463 rapidly induced therapeutically relevant levels of target-specific CD8 T-cells via in vivo expansion that correlate with clinical efficacy. Given that the levels of EO2463 and B cell target specific CD8 T-cells correlate with objective tumor responses, these measures have the potential to be developed as predictive biomarkers.
"The data presented in this abstract further strengthen confidence in EO2463 as a unique treatment-candidate for indolent NHL across different disease settings. It is exciting that EO2463 induced expansions of specific CD8 T-cells - which is easily measured - can be envisioned as potential biomarkers for clinical outcomes for patients treated with EO2463," said Jan Fagerberg, Chief Medical Officer at Enterome.
Addressing Unmet Need in Watch-and-Wait Patients
EO2463 shows particular promise for patients in the watch-and-wait setting, who are currently monitored but usually do not receive any treatment. While patients in this setting often have visibly swollen lymph nodes, no treatment other than watchful waiting is indicated under the current standard of care, as long as there are no troublesome symptoms. Nevertheless, these patients often are understandably anxious about their disease, which usually progresses.
"EO2463 is particularly well-suited for patients in the watch-and-wait setting, who are currently being monitored, but usually do not receive any other treatment. EO2463 is well-tolerated, easy to administer and has shown robust tumor-specific immunogenic activity, as well as clear monotherapy objective responses in clinical testing," said Pierre Belichard, Chief Executive Officer of Enterome.
OncoMimics™ Technology Platform
EO2463 is an innovative, off-the-shelf OncoMimics (搜索)™ active immunotherapy that combines four synthetic 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 (搜索), CD22 (搜索), CD37 (搜索), and CD268 (搜索) (BAFF receptor (搜索)). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).
OncoMimics (搜索)™ consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or cell lineage markers in B cell lymphomas. These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8 T-cells, primed by gut bacteria, and cross-reactive with TAAs/B cell markers. Because the peptides are "non-self," OncoMimics™ avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors.
Clinical Development and Regulatory Progress
The company is actively engaged in the regulatory process to further advance EO2463 into a Phase 3 registrational trial. Enterome's three most advanced product candidates have shown positive early data in Phase 2 clinical development, supporting the novel OncoMimics (搜索)™ modality.
The synthetically produced peptides are designed in silico, mining Enterome's proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.
Disease Background and Treatment Landscape
Indolent non-Hodgkin lymphoma (搜索) is a group of difficult to treat chronic conditions with relapses - such as follicular lymphoma (搜索) and marginal zone lymphoma (搜索) - characterized by slow progression and few symptoms, and reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators on the need for a well-tolerated and effective monotherapy to stop or slow progression for patients in the watch-and-wait setting.