IN8bio Reports 100% 1-Year Complete Remission in Phase 1 INB-100 Trial

June 13, 2024 - IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company, has revealed updated results from its Phase 1 trial of INB-100 during the European Hematology Association (EHA) 2024 Hybrid Congress. This trial focuses on innovative gamma-delta T cell therapies for leukemia.

The INB-100 trial results were promising, showing that all evaluable leukemia patients (n=10) remained alive and progression-free, maintaining complete remission (CR) for one year as of May 31, 2024. This outcome is particularly notable since historical data indicates that up to 50% of hematologic malignancy patients undergoing hematopoietic stem cell transplantation (HSCT) with reduced intensity conditioning (RIC) relapse within a year, often resulting in death.

Two patients have surpassed three and a half years without relapse, and a third is nearing the three-year mark. For the first time, the trial demonstrated the in vivo expansion and persistence of haplo-matched, allogeneic cellular therapy at 365 days, with gamma-delta T cell levels in the blood exceeding those previously linked to higher survival rates.

The safety profile of INB-100 is favorable, with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), neurotoxicity, or immune effector cell-associated neurotoxicity syndrome (ICANS) observed. There were also no serious infections reported. However, one patient did pass away due to idiopathic pulmonary fibrosis, a known transplant-related toxicity, not due to disease progression. Additionally, two patients with TP53 mutations, including one with Ph-acute lymphocytic leukemia (ALL) treated with seven previous regimens and another with MDS/MPN syndrome, relapsed but are still alive. Preventing relapse remains a critical unmet need as leukemic relapse is the primary cause of death post-HSCT.

The trial is being expanded to include an additional ten patients at Dose Level 2 (DL2), the recommended Phase 2 dose, and enrollment is ongoing. Updated data is expected later in 2024 and 2025. IN8bio plans to discuss a potential registrational trial with the U.S. Food and Drug Administration (FDA) during a Type B meeting this summer.

“These findings highlight the potential of allogeneic INB-100 gamma-delta T cells to provide durable, relapse-free periods for high-risk or relapsed AML and other hematologic malignancies undergoing HSCT,” stated Dr. Trishna Goswami, Chief Medical Officer at IN8bio. “100% of evaluable patients are in complete remission after one year of follow-up. The initial three patients were high-risk or relapsed AML cases with complex cytogenetics, such as trisomy of chromosome 8 and deletion of chromosome 7. All three are alive and progression-free, with one lost to follow-up after relocating out of state. Achieving these outcomes in patients undergoing a RIC regimen, which carries a higher relapse risk, in a median age population of 68 is very encouraging. We look forward to advancing our gamma-delta T cell therapy.”

Dr. Joseph P. McGuirk, Division Director of Hematologic Malignancies and Cellular Therapeutics at The University of Kansas Cancer Center, added, “The emerging safety, efficacy, and durability profile of this gamma-delta T cell therapy supports its potential to improve relapse-free survival for patients with blood cancers following allogeneic stem cell transplantation. Approximately 25% of patients relapse within 100 days, and nearly half by one year post-stem cell transplant, leading to treatment failure and mortality. These results are promising and suggest that donor-derived gamma-delta T cells may prevent relapse, improving relapse-free survival for patients with hematologic malignancies.”

The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose-escalation study of allogeneic gamma-delta T cells from matched related donors. These cells are expanded and activated ex vivo and administered to leukemia patients post-HSCT. Conducted at The University of Kansas Cancer Center (KUCC), the trial's primary endpoints include safety and tolerability, with secondary endpoints measuring rates of GvHD, relapse, and overall survival.

IN8bio focuses on developing gamma-delta T cell therapies for solid and liquid tumors. Its DeltEx platform uses allogeneic, autologous, iPSC, and genetically modified approaches to create therapies that target tumor cells. The company is also conducting Phase 2 and two Phase 1 trials for different cancer types, with a portfolio of preclinical programs aimed at other hematological and solid tumors.

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