On July 27, 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, JUL 27, 2022, View Source [SID1234617007]). This program is an allogeneic, or donor-derived, gamma-delta T cell therapeutic candidate in development for patients with high-risk leukemias undergoing haploidentical hematopoietic stem cell transplant (HSCT). William Ho, Chief Executive Officer of IN8bio, will be discussing these results at the 3rd Annual Gamma-Delta T Therapies Summit, being held July 26-28, in Boston.
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"We are excited about the early signals of long-term durable responses from gamma-delta T cell therapy in these high-risk AML patients with complex cytogenetics," said Trishna Goswami, M.D., Chief Medical Officer of IN8bio. "Despite the up to 51% anticipated one-year relapse rate of the patients enrolled in the trial, all three remain alive and disease free for more than one-year post-transplant. These data are highly encouraging, with the potential to increase the rates of cures in AML patients without significant added toxicities observed to date."
The Phase 1 clinical trial continues to show positive clinical trends with the first three patients remaining alive and progression-free. Despite multiple cytogenetic abnormalities and a high risk of relapse, these patients remain in remission 26.5, 24.2 and 12.5 months post-transplant, respectively. Immune system reconstitution at six months post-treatment demonstrates continued normal function including observed elevations in T cells, B cells, and gamma-delta T cells. No treatment emergent serious adverse events (SAEs), including graft-vs-host disease (GvHD), cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) have been observed. The clinical trial is ongoing and additional patients have been recruited, with updated data expected in late 2022.
As of June 30, 2022
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 from matched related donors 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.