IN8bio announces updated data from INB-100 trial

IN8bio announced updated data from its Phase 1 investigator-sponsored trial of INB-100 in patients with hematologic malignancies. The data, which will be presented in a poster presentation at the 65th ASH Annual Meeting & Exposition this evening, demonstrated that 100% of evaluable leukemia patients treated remained alive, progression-free, and in durable complete remission, or CR, as of November 3. The company believes this data indicate the curative potential of INB-100 to provide durable relapse free periods for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation, or HSCT. The CRs to date, combined with INB-100’s benefit/risk profile are encouraging for the treatment of hematological malignancies and the trial is being expanded by ten patients at Dose Level, or DL, 2, the recommended Phase 2 dose, or RP2D. Additional expansion patient enrollment is on-going and updated data is expected to be presented at medical meetings in 2024. The latest INB-100 trial data on immune reconstitution showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment. Patients who received INB-100 treatment at DL 2 exhibited gamma-delta T cell levels: An average of 48.9x greater at 60 days compared with patients undergoing haploidentical HSCT without INB-100 therapy. An average of 7.6x greater than those achieved in DL 1, which continues to demonstrate a dose-response related to the gamma-delta T cell infusion. An average of 2.7x greater at 365 days than levels found in DL 1, which is above levels previously associated with improved survival outcomes. Elevations in CD4+, CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response and stable reconstitution of the immune system post-transplant. New cytokine data following gamma-delta T cell infusion demonstrate peripheral increases in pro-inflammatory cytokines in the plasma, such as interferon-gamma, IL-6 and IL-15 early post-infusion, demonstrating broad immune activation. Low grade acute graft versus host disease observed in 60% of patients treated. Cases were all steroid responsive. No dose limiting toxicities have been observed. All evaluable patients across DL 1 and DL 2 remained on study and in CR, with two patients now remaining progression free for over 3 years. Treated patients have remained progression free for 42.7, 40.3, 28.6, 14.3, 12.2, 12.0, 9.0, 5.6, 5.3 and 4.9 months, respectively.