Enterome SA

60% (12/20) complete response rate after treatment with EO2463 in combination with lenalidomide and rituximab (R2) EO2463 plus R2 was well tolerated in patients with follicular and marginal zone lymphoma EO2463 plus R2 combination treatment resulted in higher-than-expected rates of complete remission so far in this study compared to historical data for R2 alone 23 June, 2025，Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, presented positive interim results for its OncoMimics™ immunotherapy EO2463 from Cohorts 1 and 4 of the ongoing open label Phase 1/2 SIDNEY trial in patients with indolent non-Hodgkin lymphoma (iNHL), at the International Conference on Malignant Lymphoma (ICML) in Lugano. Interim data including 24 patients with follicular and marginal zone lymphoma (relapsed/refractory iNHL) showed that treatment with EO2463 in combination with lenalidomide and rituximab (R2) was well tolerated and demonstrated encouraging signs of efficacy that appear better than historical data in similar patients treated with R2. Importantly, EO2463 showed direct anti-lymphoma activity, including partial responses to the OncoMimics™ monotherapy, during the first six weeks of the study, a short time period during which just the first three doses of EO2463 were administered, before the protocol called for initiation of treatment with lenalidomide (followed subsequently by adding rituximab). Moreover, once lenalidomide and rituximab were added, the effect of EO2463 appeared to support a deepening of responses, resulting in a complete response rate of 60%, higher than would have been expected with R2 alone, based on historical data1. Pierre Belichard, CEO of Enterome said, “The EO2463 interim results are very encouraging, demonstrating exceptional tolerability for an active immunotherapy, and showing a clear signal that the combination with R2 can provide more robust responses in this patient population over R2 alone. This is consistent with the strong response rate we observed with EO2463 monotherapy in patients with low tumor burden disease, the so-called ‘watch-and-wait’ population, included in Cohort 2 of SIDNEY. While we plan to focus our near-term efforts on initiating a registrational Phase 3 trial of EO2463 for the watch-and-wait population, this evidence of a complementary effect in combination with R2 in relapsed/refractory iNHL is very exciting and offers new hope for this patient group, most of whom still see insufficient efficacy with available therapeutics.” EO2463 is designed to expand pre-existing memory CD8+ T cells recognizing non-self-protein sequences from gut bacteria, which mimic several purposefully selected B cell antigens. The interim SIDNEY data from Cohorts 1 and 4 presented at ICML show fast, robust, and durable expansion of the specific CD8+ T cells that were active against EO2463 mimic peptides and the targeted B cell epitopes. Most important, the magnitude of the EO2463-driven expansion of specific CD8+ T cells correlated with the probability of complete remission upon treatment with EO2463 combined with R2 in the SIDNEY study. EO2463 in combination with lenalidomide and rituximab (R2 ) is well tolerated in patients with follicular and marginal zone lymphoma. Jan Fagerberg, Chief Medical Officer of Enterome, said, “These early efficacy results suggest EO2463 offers additional benefit when used together with the R2 regimen in patients with relapsed/refractory iNHL. We previously reported data from Cohort 2 of SIDNEY, at ASH in December 2024, showing that EO2463 OncoMimics™ monotherapy generated a 46% objective response rate in patients who are usually proposed ‘watchful waiting’ and no active anti-lymphoma therapy – and also had an excellent tolerability profile. In short, taken together, these SIDNEY data indicate that this well tolerated novel active immunotherapy may well have broad potential across hematological malignancies.” EO2463 is an innovative, off-the-shelf OncoMimics™ 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, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 active immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape. SIDNEY is an ongoing open label Phase 1/2 study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy with lenalidomide/rituximab in up to 55 patients with follicular lymphoma and marginal zone lymphoma including four cohorts of three patient populations: Cohort 2: patients with newly diagnosed, previously untreated low tumor burden disease, not in need of standard of care therapy, i.e., the “watch-and-wait” setting; treatment = EO2463 monotherapy Cohort 3: patients with newly diagnosed, previously untreated low tumor burden disease, in need of therapy; treatment = EO2463 in combination with rituximab Cohorts 1 and 4: patients with relapsed/refractory disease and at least one prior treatment; treatment = EO2463 in combination with lenalidomide and rituximab (R2) OncoMimics™ are synthetically produced peptides designed in silico using AI and machine learning to mine Enterome’s extensive proprietary database of microbial bacteria. Unlike cancer antigens, OncoMimics™ bypass a gating process, known as thymic deletion, that prevents the immune system from mounting an attack against the “self” proteins (e.g. antigen) on tumor and blood cancer cells. Furthermore, that they trigger a more targeted, rapid and robust immune response than would otherwise be possible, because very early in human development the immune system learns to protect the body from microbiome bacteria. This means that OncoMimics™ call up memory CD8+ T cells that selectively target the cancer cells that carry the mimicked antigen(s). This therapeutic strategy takes inspiration from and is de-risked by emulating the gut microbiome’s causal role in certain autoimmune diseases. OncoMimics™ are easy to manufacture, store, distribute and administer as an “off-the-shelf” subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies. 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 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 antigen (TAA) based on the big-data insights from millions of gut bacterial proteins, that live in humans. The content above comes from the network. if any infringement, please contact us to modify.

Proceeds to fund Phase 1/2 trial of EO2463 OncoMimics™, as a monotherapy or in combination, to treat multiple forms of indolent non-Hodgkin lymphoma (iNHL) $9 million from new investor The Institute for Follicular Lymphoma Innovation (IFLI) $10 million from existing specialist investors, including The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP) June 12, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, has raised $19 million in a new private financing to advance its lead clinical program EO2463 OncoMimics™ immunotherapy to treat indolent non-Hodgkin lymphoma (iNHL). The new funds will be used to expand and finalize the ongoing Phase 1/2 SIDNEY clinical trial of EO2463 and prepare the candidate for a registrational trial. New U.S. investor The Institute for Follicular Lymphoma Innovation (IFLI), a global non-profit foundation dedicated to advancing research and treatment for follicular lymphoma, invested $9 million in the round, of which $5 million will be allocated to Enterome upon closing and an additional $4 million in conditional tranched funding. Existing shareholders invested an additional $10 million including: SymBiosis, a U.S. venture capital firm; Seventure Partners, based in France; Lundbeckfonden BioCapital from Denmark; Primo Capital, an Italian venture capital and private equity firm; and The U.S. Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP). “Attracting highly specialized blood cancer investor IFLI to this financing demonstrates the conviction of our new and existing investors in the potential of OncoMimics™ for blood and solid tumor cancers,” said Pierre Bélichard, Enterome’s Chief Executive Officer. “We currently are generating exciting clinical proof of concept data for EO2463 monotherapy in several iNHL patient populations included in the Phase 1/2 SIDNEY clinical trial. Most importantly, EO2463 has shown robust clinical efficacy and exceptional safety and tolerability – which is especially impressive for such a potent immunotherapy. This offers a new hope for these patients and a rare opportunity to create an entirely new market segment for an impactful therapeutic. This financing will enable us to continue the SIDNEY trial of EO2463 and prepare to launch a first pivotal Phase 3 trial of this candidate for the ‘watch-and-wait’ iNHL population.” The company presented interim SIDNEY dataat the American Society of Hematology (ASH) conference in December 2024, showing highly encouraging responses in the Cohort 2 of “watch and wait” iNHL patients in the ongoing SIDNEY study. This population, as the name suggests, is generally not eligible to receive other treatments due to the unacceptable risk-benefit ratio (in this iNHL sub-population) of the most commonly used blood cancer therapies. The company also recently disclosed having held positive meetings with both FDA (Type C meeting) and EMA (Scientific Advice), outlining a clear regulatory path registration for marketing authorizations in “watch-and-wait” iNHL. “This investment aligns with IFLI’s mission to accelerate the development of innovative therapies and precision biomarkers for follicular lymphoma,” said Michel Azoulay, MD, Chief Medical Officer at IFLI. “EO2463 represents a novel class of synthetic, off-the-shelf Immunotherapeutics with a unique mechanism of action that selectively targets malignant B cells. We are particularly interested in supporting Enterome’s efforts to demonstrate EO2463’s clinical efficacy across multiple lines of therapy, including in relapsed and refractory settings.” Enterome recently announced that it will present new data showing EO2463 also has a meaningful impact when tested in combination with standard of care in relapsed and refractory iNHL patients at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21. Previous findings presented at ASCO in 2024 in the relapsed and refractory patient population further suggested the potential to identify individuals most likely to benefit from EO2463 treatment, supported by biomarker analyses. Lore Gruenbaum, Chief Scientific Officer at LLS, said, “It is important for us to continue to support Enterome, a company working to develop novel therapeutics based on our shared commitment to create better therapies for blood cancers. LLS has invested over $1.8 billion in groundbreaking research since our inception in 1949. Our active partnership with Enterome, through our Therapy Acceleration Program, will continue to advance the clinical development of the OncoMimics™ family of novel immunotherapeutics for the benefit of blood cancer patients. We are particularly excited to help advance EO2463 which has shown promising signs of efficacy as monotherapy with excellent safety and tolerability in ‘watch-and-wait’ iNHL patients, who currently have no approved treatment options.” EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimics™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that mimic the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape. SIDNEY is an ongoing 12-month open label Phase 1/2 study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in up to about 55 patients with follicular lymphoma and marginal zone lymphoma including divided into three cohorts: newly diagnosed patients eligible to watch-and-wait (monotherapy); newly diagnosed patients in need of therapy / first line (combo with rituximab); patients with relapsed/refractory disease (combo with R2). In addition to safety, survival, response rates and other measures of efficacy are being collected. OncoMimics™ were inspired by the microbial origin of certain autoimmune diseases. The Company uses AI and machine learning to identify microbial proteins that closely mimic the structure, effect or actions of specific cancer antigens (as well as hormones or cytokines). Memory T cells against microbial antigen are created during early development, sometimes leading to autoimmune disorders. In the case of OncoMimics™, however, this means that the immune system can mount a rapid, robust and durable immune response that is highly targeted and specific for the OncoMimics™ and the cancer antigens they closely resemble. This is possible because, unlike cancer antigens, OncoMimics™ bypass the biological process, known as thymic deletion, that prevents the immune system from mounting an attack against the “self” proteins (e.g. antigen) on tumor and blood cancer cells. Once activated, the immune system attacks with high specificity and potency the cancer antigens targeted by the OncoMimics™, killing the cancer cells that carry them. OncoMimics™ are synthetic peptides that are easy to manufacture, store, distribute and administer as an off-the-shelf subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies. Enterome SA (www.enterome.com) is a privately held clinical-stage biopharmaceutical company developing OncoMimics™, a new proprietary immunotherapeutic modality inspired by the microbial origin of certain autoimmune diseases, to treat cancer. The Company’s wholly-owned OncoMimics™ pipeline includes three distinct clinical-stage drug candidates: EO2463 to treat indolent non-Hodgkin lymphomas; EO4010 to treat third-line colorectal cancer; and EO2401 to treat glioblastoma and adrenal tumors. Each of these candidates has shown positive early clinical efficacy and exceptional safety and tolerability. The content above comes from the network. if any infringement, please contact us to modify.

The company leverages machine learning and AI to detect microbial proteins that mimic certain cancer antigens. Credit: metamorworks/Shutterstock. Enterome has secured $19m in new private funding to progress its EO2463 OncoMimics immunotherapy, targeting indolent non-Hodgkin’s lymphoma (iNHL). The funding will support the expansion and completion of the ongoing Phase I/II SIDNEY trial and prepare for a registrational trial. The Institute for Follicular Lymphoma Innovation (IFLI), a new US investor, contributed $9m to the funding round, $5m of which will be immediately available to Enterome, with an additional $4m in conditional tranches. Current shareholders Seventure Partners, SymBiosis, Lundbeckfonden BioCapital, the US Leukemia & Lymphoma Society Therapy Acceleration Program and Primo Capital have collectively invested an additional $10m. EO2463 is an off-the-shelf immunotherapy candidate that joins four synthetic OncoMimics peptides. EO2463 selectively targets several B-cell markers and is designed to destroy malignant B lymphocytes. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence By covering a wide range of targets on malignant B cells, the therapy aims to enhance safety and efficacy while minimising the potential of tumour cells for developing immune-resistance mechanisms such as antigen escape. Recently, Enterome announced its plan to present new data at the International Conference on Malignant Lymphoma (ICML) in Lugano on 21 June 2025. The data will demonstrate the impact of EO2463 in conjunction with standard care for relapsed and refractory iNHL subjects. Enterome noted that OncoMimics, the basis for EO2463, was inspired by the microbial origin of specific autoimmune conditions. It leverages machine learning and AI to detect microbial proteins that mimic the effect, structure or actions of certain cancer antigens. Enterome CEO Pierre Bélichard stated: “We are currently generating exciting clinical proof of concept data for EO2463 monotherapy in several iNHL patient populations included in the Phase I/II SIDNEY clinical trial. “Most importantly, EO2463 has shown robust clinical efficacy and exceptional safety and tolerability – which is especially impressive for such a potent immunotherapy. “This financing will enable us to continue the SIDNEY trial of EO2463 and prepare to launch a first pivotal Phase III trial of this candidate for the ‘watch-and-wait’ iNHL population.” Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now