On March 28, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported a clinical update from the ongoing Phase 1 trial of INB-100 (Press release, In8bio, MAR 28, 2022, View Source [SID1234611034]). This program is an allogeneic, or donor-derived, gamma-delta T cell therapeutic candidate in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT). Two of the INB-100 patients treated have been in remission for nearly two years, and the third patient is in continuing remission at nine months post-treatment.
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The exploratory clinical correlative data highlights the robust reconstitution of the immune system of treated patients. The data show positive trends in levels of immune cells, including alpha-beta T cells, B cells and gamma-delta T cells. This suggests that the systemic immune system may show long-term positive trends in treated patients. The toxicity profile continues to be manageable with no treatment-related Grade 3 or greater adverse events. The clinical and correlative update was presented at the virtual European Society for Blood and Marrow Transplantation (EBMT) 48th Annual Meeting.
"We are encouraged by the patients’ responses to INB-100 treatment given this population’s high risk for recurrence," said Lawrence S. Lamb, Ph.D., Chief Scientific Officer and co-founder of IN8bio. "As we near the two-year mark in remission for our first and longest enrolled patient, we continue to monitor data from our ongoing clinical correlative studies, which are indicating a positive systemic immune response following the infusion of INB-100. Patient recruitment in this trial is continuing, and we look forward to releasing further clinical and correlative data with additional patients later this year."
About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.