NASDAQ:INAB
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IN8bio, Inc (NASDAQ:INAB) presented updated results from its Phase I INB-100 trial at the European Hematology Association (EHA) Congress on June 13th in Madrid, Spain. Details of the presentation were provided in a press release and conference call after the close on June 13th, 2024 along with a slide deck to guide the discussion. Stakeholders have been eagerly awaiting the update on this trial since impressive data was presented back in December 2023 at the American Society of Hematology (ASH) Annual Meeting. Now six months later, all (N=10) of the treated leukemia patients achieved complete remission at the one-year mark. Of the 10 patients evaluated, 30% have achieved overall survival in excess of three years and one beyond four years. Only one patient has died, and this was attributed to idiopathic pulmonary fibrosis and not the experimental medication or leukemia. Multiple resources suggest that about 50% of patients relapse 12 months after hematopoietic stem cell transplant for hematological malignancies, highlighting the remarkable results that were achieved with no patients relapsing during the year long period.
The achievement is even more impressive when subject risk profiles are considered. The average age of the 10-patient group was approximately 68 years1 and over half had mutations or unfavorable cytogenetics associated with worse performance. Complete remission at one year is an excellent result that provides more confidence of success in a registrational trial which will be the topic of IN8bio’s next interaction with the FDA.
IN8bio will expand the trial to enroll another 10 patients at the recommended Phase II dose which is a single dose of 3 x 106 γδ T cells/kg. Further updates from the trial are expected over the remainder of 2024 and in 2025. The company plans to discuss the details of a registrational trial with the FDA in a Type B meeting this summer.
Anticipated Phase II Details
The proposed randomized controlled trial will enroll about 200 subjects equally divided between the γδ T cell experimental arm and the standard of care arm. The primary endpoint will be relapse-free survival. Secondary endpoints will include adverse events, time to relapse, overall survival (OS) and quality of life (QoL).
Persistence
In the December 2023 update, IN8bio presented data showing a year of persistence for γδ T cells in the two trial cohorts. The persistence was especially strong in the second dosing level, which also demonstrated in vivo expansion. The data six months later reinforced this finding and closely matched December’s data as shown below.
Safety
Safety was another strong point reinforced in the updated information for INB-100. No dose limiting toxicities, cytokine release syndrome (CRS), neurotoxicity or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. There have been few serious infections which can arise during immune system reconstitution. One patient died due to idiopathic pulmonary fibrosis, which is an associated adverse response to transplants. The patient population presented several high-risk features including trisomy of chromosome 8 and deletion of chromosome 7 as well as other difficult mutations that appeared in six of the ten evaluable subjects. Below we summarize the treatment-emergent adverse events (TEAEs) that occurred in 2 or more subjects.
The INB-100 trial will continue with 10 more subjects planned and IN8bio will meet with the FDA to discuss the design of its registrational Phase II study. 100% remission at one year for all 10 patients and persistence and durability of γδ T cells are strong indicators of the success of this program. Safety has been a strong attribute of INB-100, with most of the adverse events related to transplantation and not the γδ intervention. Graft vs. host disease (GvHD) has been limited with no greater than Grade 2 GvHD and 30% incidence of chronic GvHD.
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1. In the Luznik 2008 piece, median age was 46 years. Luznik, L. et al. HLA-Haploidentical Bone Marrow Transplantation for Hematologic Malignancies Using Nonmyeloablative Conditioning and High-Dose, Post-transplantation Cyclophosphamide. Biology of Blood and Marrow Transplantation 14:641-650 (2008)
