IN8bio, Inc. announced the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme (GBM). Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation (HSCT).

The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS. In April 2023, the Company presented data at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showing that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR). 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.

Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A clinical update with additional enrolled patients will be presented at the 65th ASH Annual Meeting being held December 9-12, 2023 in San Diego, CA. The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in ?Arm A? of the study.

The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients. INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation.

GBM remains a significant unmet need, treatment options and associated outcomes for GBM, a highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months. INB-400 is IN8bio?s DeltEx chemotherapy resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or ?off-the-shelf?

DeltEx DRI technology. INB-100, IN8bio?s DeltEx Allo, is an allogeneic product candidate, initially developed for the treatment of patients with hematologic malignancies undergoing hematopoietic bone marrow transplantation (HSCT). It is currently being evaluated in a Phase 1 dose escalation clinical trial, marking the first clinical trial of an expanded and activated allogeneic gamma-delta T cell immunotherapy.