IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma - Seite 2

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 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.

About INB-100
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.

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. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.