Phase 2 Clinical Trial of INB-400 in GBM
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.
About INB-400
INB-400 is IN8bios 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.
About INB-100
INB-100, IN8bios 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.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for
solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bios DeltEx platform employs allogeneic,
autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio is
currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with hematologic malignancies undergoing haploidentical hematopoietic stem cell transplantation. IN8bio is initiating enrollment for a company-sponsored multi-center Phase 2
clinical trial of INB-400 in newly diagnosed glioblastoma, which received IND