On January 5, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported a clinical update from the ongoing Phase 1 trial evaluating INB-200 in patients with newly diagnosed GBM and provided pipeline goals for 2023 (Press release, In8bio, JAN 5, 2023, View Source [SID1234625871]).

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Clinical Update from the INB-200 Phase 1 Trial

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.

"We believe that 2023 will be a pivotal year for IN8bio as we advance our innovative chemotherapy-resistant cell therapy to improve outcomes for patients living with cancer," said William Ho, Chief Executive Officer of IN8bio. "We are encouraged to see greater durability of response with increased dosing of our cells, along with a continued favorable safety profile in this Phase 1 study of INB-200. We look forward to multiple milestones across our pipeline in the year ahead, including initiating our Phase 2 study of INB-400 in newly diagnosed GBM and advancing additional solid tumor indications outside of GBM."

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 Q3 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.