IN8bio, Inc. announced a clinical update from the ongoing Phase 1 trial evaluating INB-200 in patients with newly diagnosed GBM and provided pipeline goals for 2023. As of December 31, 2022, eight patients have been dosed with INB-200: three in Cohort 1 (single dose), four in Cohort 2 (three doses) and one in Cohort 3 (six doses). Enrollment is ongoing, with clinical updates expected throughout 2023.

Key findings from the ongoing study include: All patients in Cohort 2 remained progression free at 18.9, 14.8, and 8.7 months, respectively. The third patient died at 8.7 months due to a pulmonary embolism unrelated to treatment with no evidence of relapse prior to death.Two patients continue to exceed the median survival for GBM patients with the standard Stupp regimen, suggesting that increasing doses of gamma-delta T cells may favor longer PFS and overall survival (OS). The first patient dosed in Cohort 3 has received five doses of gamma-delta T cells with no evidence of additional toxicities.

The patient has no local GBM relapse, which is typical in 95% of GBM cases, but does have evidence of distal leptomeningeal disease.There have been no treatment-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) observed to date. There have been no instances of cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS).Adverse events have been generally tolerable and include grade 1/2 anemia, fevers, headaches, myelosuppression, and nausea. Importantly, to date, repeat dosing does not demonstrate a change in the toxicity profile.

Anticipated 2023 Pipeline Goals: INB-100: Report Phase 1 ongoing trial data from leukemia patients undergoing haploidentical stem cell transplantation (HSCT); define maximum tolerated dose for INB-100. INB-200 in GBM: Complete enrollment of Cohort 3 in the Phase 1 trial; report additional data and topline results with longer-term follow-up. INB-300: Present preclinical data demonstrating proof-of-concept of non-signaling CAR (ns-CAR) platform in 1H 2023.

INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM by Third Quarter 2023. INB-410: Submit IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM. New solid tumor indications: Announce and present relevant data at a scientific conference in 1H 2023.