IN8bio announces new data from Phase 1 trial of INB-100

IN8bio announced new positive data from the Phase 1 investigator-sponsored trial of INB-100 in leukemia patients. The data presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation, EBMT, showed that 100% of evaluable patients treated with INB-100 remained alive, progression-free, and in durable complete remission, CR, as of April 21, 2023, indicating the curative potential of INB-100 for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation, HSCT. "We are thrilled to report that 100% of evaluable dosed patients remain in morphological CR with the first three high-risk AML patients with complex cytogenetics now alive and relapse-free, with one patient surviving for as long as 3 years," said Dr. Trishna Goswami, IN8bio’s Chief Medical Officer. Further, "INB-100 has demonstrated, for the first time, in vivo expansion and persistence of an allogeneic, or donor-derived cellular therapy at the higher levels associated with greater survival outcomes." The latest data on immune reconstitution presented at EBMT showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 180 days post-treatment. Patients who received INB-100 treatment at Dose Level 2 exhibited an average of 82.9x greater gamma-delta T cell expansion at 60 days compared to patients undergoing haploidentical HSCT without INB-100 therapy. The gamma-delta T cell levels in Dose Level 2 patients are also, on average, 12.8x greater than those achieved in Dose Level 1, demonstrating a dose-response related to the gamma-delta T cell infusion. The study’s updated safety data reported low-grade graft versus host disease in all patients treated, which was steroid-responsive, and had a more rapid onset at higher dose levels. No dose limiting toxicities have been observed. As of April 21, 2023, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years.