Clinical Trials
2
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2012
Active, not recruiting
1
50.0%
Recruiting
1
50.0%
No approval data available
- The U.S. FDA granted Orphan Drug Designation to Enterome's EO2463 OncoMimics immunotherapy for treating indolent non-Hodgkin lymphoma patients in the watch-and-wait setting. - EO2463 demonstrated a 52.6% objective response rate in follicular lymphoma patients and 47.6% in the overall watch-and-wait population during the SIDNEY Phase 1/2 trial. - The designation provides seven years of market exclusivity upon approval and validates the unmet medical need for active treatment options in watch-and-wait patients. - EO2463 is an off-the-shelf immunotherapy targeting multiple B-cell markers including CD20, CD22, CD37, and CD268 to expand cytotoxic T-cells and avoid immune tolerance.
- Enterome's OncoMimics™ 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. - 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. - The therapy shows particular promise for patients in the watch-and-wait setting, offering a well-tolerated treatment option where current standard of care provides only monitoring.
- Enterome has appointed Dr. Mehrdad Mobasher, former Chief Medical Officer at BeiGene and current IFLI Executive Partner, to its Board of Directors to strengthen leadership in developing OncoMimics immunotherapies. - The company's lead candidate EO2463 has shown positive Phase 2 interim data in low tumor-burden follicular lymphoma and received FDA Fast Track designation for the watch and wait setting. - IFLI, a key investor that contributed up to $9 million in Enterome's $19 million funding round, continues to support the development of OncoMimics therapies targeting B-cell lymphomas. - Enterome's OncoMimics platform represents a novel immunotherapy approach that induces rapid expansion of memory T-cells, with three candidates showing positive early Phase 2 data across blood cancers and solid tumors.
- Enterome SA raised $19 million in private financing to advance EO2463 OncoMimics immunotherapy through Phase 1/2 trials for indolent non-Hodgkin lymphoma treatment. - The Institute for Follicular Lymphoma Innovation invested $9 million as a new investor, while existing shareholders contributed $10 million to support the clinical development program. - EO2463 demonstrated robust clinical efficacy and exceptional safety in "watch-and-wait" iNHL patients, who currently have no approved treatment options available. - The company received positive regulatory guidance from both FDA and EMA, establishing a clear path toward registration for marketing authorization in the watch-and-wait population.
- Enterome will present positive Phase 2 data for EO2463, its lead OncoMimics immunotherapy, in treating indolent non-Hodgkin lymphoma at the International Conference on Malignant Lymphoma on June 21, 2025. - The SIDNEY study demonstrates EO2463's potential as a frontline therapy across multiple patient groups, including watch-and-wait, first-line, and relapsed/refractory settings. - Enterome recently held a positive Type-C meeting with the FDA, establishing a clear regulatory pathway to marketing approval for EO2463 in indolent non-Hodgkin lymphoma. - EO2463 is an innovative off-the-shelf immunotherapy combining four synthetic peptides that target multiple B-cell markers including CD20, CD22, CD37, and CD268.
- Enterome's OncoMimics™ immunotherapy EO4010 combined with nivolumab achieved 40% survival at 12 months in 20 patients with MSS/pMMR metastatic colorectal cancer, with median survival of 11.3 months. - The treatment demonstrated excellent safety and tolerability while generating specific immune responses in 80% of patients against tumor-associated antigens. - Results from the Phase 1/2 AUDREY trial showed objective responses including tumor shrinkage in liver and lung metastases, a rare outcome in this challenging patient population. - Data presented at ASCO 2025 support continued development of EO4010 for colorectal cancer treatment, addressing significant unmet medical needs in MSS/pMMR disease.
