On December 10, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported updated data from the ongoing Phase 1 trial of INB-100, an allogeneic, haploidentical gamma-delta T cell therapy in older patients with hematologic malignancies undergoing haploidentical stem cell transplant (HSCT) with reduced intensity conditioning (RIC) at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being hosted in San Diego, CA (Press release, In8bio, DEC 10, 2024, View Source [SID1234648986]).

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"This data demonstrates the potential of allogeneic INB-100 gamma-delta T cells to provide durable relapse-free remissions in high-risk or relapsed AML patients undergoing HSCT," said Dr. Joseph P. McGuirk, Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics Medical Director, Blood and Marrow Transplant, The University of Kansas Cancer Center. "Older, frailer patients who receive non-myeloablative, reduced intensity conditioning regimens typically have a significant risk of relapse. Historically, approximately 25% of AML patients undergoing HSCT would be expected to have a leukemic relapse within the first 100 days post-transplant, with up to nearly 50% of such patients experiencing relapse by one-year, which remains the primary cause of death. The longer AML patients remain in remission post-HSCT, the greater their probability of survival. These observed long-term durable remissions using allogeneic gamma-delta T cells are very encouraging and we look forward to announcing additional data next year."

In a poster presentation, IN8bio reported that there have been no newly reported deaths or relapses as of September 30, 2024. As of that cutoff date, median CR was at 16.4 months following a median of 19.2 months of follow-up. As previously reported, all patients (n=10) remained alive, progression-free, and in durable CR through one-year. 100% of AML patients remain in CR after a median 19.7 months of follow-up with three patients with high-risk cytogenetic AML and receiving no maintenance therapy remaining in mCR for greater than three years.

INB-100 continues to demonstrate in vivo expansion and persistence of an haplo-matched allogeneic, or donor-derived cellular, therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival. The persistence of these cells is suggestive of continued gamma-delta T cell surveillance against leukemic relapse.

In addition to the reported complete responses, INB-100 continued to demonstrate a well-tolerated safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) observed and limited mild infections. Based upon these encouraging results, the INB-100 trial has been expanded to enroll additional patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D). Enrollment of additional patients into the expansion cohort is on-going and updated data, are expected to be reported in the first half of 2025.

Summary of Data Presented at ASH (Free ASH Whitepaper)

The Phase 1 investigator-sponsored trial enrolled and treated ten patients at one of two dose levels (D1 or D2). The median age was 68 years with the majority of patients diagnosed with AML in CR1. Two patients (009 and 011) had TP53 mutations, a tumor suppressor that results in poor prognosis, rapid progression and reduced lifespan due to an inability to respond to mutated or damaged DNA.

The latest INB-100 trial data on immune reconstitution continues to show significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment. As of September 30, 2024, 100% of patients (n=10) surpassed one-year survival following their haplo-matched transplant and treatment with INB-100. Historically, approximately 25% of patients relapse by 100 days and 40-50% of patients relapse by one year.

Updated safety data includes:

No dose limiting toxicities (DLTs) and no treatment related deaths were observed.
Low grade (1-2) acute graft versus host disease (GvHD) observed in 60% of patients treated. Cases were all steroid responsive.
Treatment-related serious adverse events included Grade 2 rash (60%) and Grade 3 nausea (20%).
One patient death previously reported due to idiopathic pulmonary syndrome likely related to the underlying HSCT at 15.5 months, without disease progression.
No ICAN, CRS, or major infections were observed.
Seven patients across DL 1 and DL 2 remained on study and in CR, with three having surpassed three years, including one now remaining progression free for over four years.