IN8bio, Inc. (Nasdaq: INAB) announced the addition of The Ohio State University as a new clinical site for its ongoing Phase 1 trial of INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients with leukemias undergoing haploidentical stem cell transplantation. The expansion reflects strong institutional interest in the therapy and supports efforts to accelerate enrollment and complete the Phase 1 trial.
Clinical Significance and Unmet Need
The addition of Ohio State University addresses a critical need in haploidentical stem cell transplantation. According to Dr. Sarah A. Wall, Investigator and Assistant Professor in the College of Medicine at The Ohio State University, "The increased use of haploidentical donors in the last decade has created more access to potentially life-saving allogeneic transplants for many patients, particularly under-represented groups who are less likely to have fully matched donors."
Dr. Wall emphasized that the trial represents "an excellent opportunity to explore a strategy aimed at reducing the risk of graft-versus-host disease and the risk of relapse following haploidentical stem cell transplant." She will be opening and leading the trial at The James Comprehensive Cancer Center at Ohio State University.
Trial Design and Leadership
The INB-100 trial is led by Principal Investigator Dr. Joseph P. McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics, and Medical Director, Blood and Marrow Transplant at the Kansas University Cancer Center (KUCC). The study (NCT03533816) is designed to evaluate the safety, durability, and anti-leukemic activity of IN8bio's allogeneic gamma-delta T cell therapy in the post-transplant setting.
Promising Clinical Outcomes
William Ho, CEO and co-founder of IN8bio, reported encouraging clinical results: "INB-100 continues to demonstrate the potential of gamma-delta T cells to improve outcomes and reduce relapse in patients following stem cell transplantation. Multiple patients with complex, high-risk disease continue to demonstrate long-term leukemic remissions with the earliest treated patients now beyond four- and five-years relapse-free."
The company has previously presented clinical data demonstrating encouraging long-term survival outcomes relative to real-world historical data, immune reconstitution including expansion and persistence of the allogeneic INB-100 gamma-delta T cell therapy up to 1-year post treatment, and absence of severe graft-versus-host disease.
Technology Platform
Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio's lead program, INB-100, focuses on acute myeloid leukemia by evaluating haplo-matched allogeneic gamma-delta T cells given to patients following a hematopoietic stem cell transplant.
Next Steps
With multiple sites now actively screening patients, Ho indicated that the company looks forward to "completing the enrollment of the expansion cohort and providing follow-up data next year." The clinical-stage biopharmaceutical company is also evaluating autologous DeltEx DRI gamma-delta T cells in combination with standard of care for glioblastoma and advancing novel gamma-delta T cell engagers for potential oncology and autoimmune indications.
