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IN8bio Solidifies Position as a Clinical Leader of Gamma-Delta T Cell Therapy in Oncology with 100% of Treated AML Patients in Complete Remission and Receives FDA Guidance for Registrational Trial of INB-100
Received FDA guidance on the registrational path for INB-100 in acute myeloid leukemia (AML), an investigational allogeneic gamma-delta T cell therapy, with
About this update from In8bio, Inc.
[{"type":"text","content":"Received FDA guidance on the registrational path for INB-100 in acute myeloid leukemia (AML), an investigational allogeneic gamma-delta T cell therapy, with IND submission anticipated in Q1 2025. Early clinical data from investigator sponsored trials demonstrates prolonged relapse-free survival across both AML and glioblastoma (GBM) programs, compared to current standard-of-care, with both programs advancing to Phase 2 clinical development. Solidifying position as a leader in gamma-delta T cell therapy for oncology as the first company to report improvements in relapse-free survival in both solid and hematological cancers with allogeneic or autologous gamma-delta T cells. Conference call and webcast to be hosted today at 8:30 a.m. ET. Use this link to participate. A listen-only version of the webcast is available here. NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, today announced updated positive clinical data from both of the Company’s Phase 1 investigator-sponsored trials of INB-100 for hematological malignancies and INB-200 for GBM. The Company has also completed a Type B meeting with the FDA and received guidance on the registrational path to advance INB-100 for the treatment of AML. Every AML patient treated with INB-100 remains in complete remission (CR), and patients across both trials have exceeded expected progression-free survival (PFS) to date. These data continue to demonstrate the broad clinical potential of gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into Phase 2 trials. As of August 1, 2024, no new relapses have been reported since the clinical updates provided at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) annual meetings. “Our gamma-delta T cell therapies, engineered with our industry-leading manufacturing technology, continue to demonstrate their potential to eliminate residual cancer cells and to revolutionize cancer treatment,” said William Ho, CEO and co-founder of IN8bio. “The safety profile of gamma-delta T cells has been manageable and well-tolerated across both indications with no significant cell therapy-related toxicities reported to date in any pa...