The trial has been expanded to enroll an additional ten patients at Dose Level 2 (DL2), the recommended
Phase 2 dose. Enrollment and treatment of patients into the expansion cohort is ongoing, with updated data expected in late 2024 and 2025. IN8bio expects to discuss plans for a potential registrational trial for this indication with the U.S. Food
and Drug Administration (FDA) in a Type B meeting this summer.
These data demonstrate the potential of allogeneic
INB-100 gamma-delta T cells to provide durable relapse-free periods for patients with high-risk or relapsed AML and other hematologic malignancies undergoing HSCT, said Trishna Goswami, MD, Chief Medical
Officer of IN8bio. 100% of evaluable patients remain in complete remission at one year of follow-up. In this trial, the first three patients were high-risk or relapsed AML patients with complex
cytogenetics, including trisomy of chromosome 8 and deletion of chromosome 7. All three patients are alive and progression free with one
lost-to-follow-up at 42.4 months after they relocated away from the study site and out of state. Achieving these outcomes despite
giving patients a RIC regimen, which carries a higher risk of relapse, in an older population with a median age of 68 is very encouraging. We look forward to advancing our novel gamma-delta T cell therapy for patients who need additional
options.
The emerging safety, efficacy and durability profile of this novel gamma-delta T cell therapy supports its potential to improve
relapse free survival for patients with blood cancers following allogeneic stem cell transplantation, said Dr. Joseph P. McGuirk, Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and
Cellular Therapeutics, and Medical Director, Blood and Marrow Transplant, at The University of Kansas Cancer Center. Approximately 25% of patients relapse within the first 100 days, and nearly half by one year post stem cell transplant, which
remains the primary cause of treatment failure and mortality. The results of this clinical trial are very encouraging and hold promise that a novel cellular therapy using donor-derived gamma-delta T cells may prevent relapse, resulting in improved
relapse-free survival for patients with hematologic malignancies.
Conference Call Details
IN8bio will host a conference call and webcast today, Thursday, June 13, 2024, at 4:15 pm ET to review the updated clinical data from the EHA
presentation. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Companys website. To participate in the live call, please register using this link. It is
recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.
About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose-escalation trial of allogeneic derived, gamma-delta T cells from matched
related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following HSCT approximately 15 to 30 days post engraftment. The single-institution clinical trial is being conducted at The
University of Kansas Cancer Center (KUCC). The primary endpoints of this trial include safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.