IN8bio Completes Dosing of First Cohort in Phase 1 Clinical Trial
IN8bio, Inc. recently announced completion of dosing of the first patient cohort in a Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical stem cell transplant (HSCT). The three patients comprising the first cohort did not experience any severe adverse infusion reactions or dose limiting toxicities (DLTs) to date. The first two patients are at 14.5 months and 12.2 months, respectively, post-HSCT as of June 30, 2021, and continue to be in complete remission.
“For patients with high-risk leukemia, the availability of HSCT is a path toward a potential cure, but rates of leukemic relapse remain high,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “Research by our Chief Scientific Officer, Dr. Lamb, and others has shown that that high numbers of circulating gamma-delta T cells have been correlated with improved survival outcomes in these patients. Our goal with INB-100 is to generate an anti-leukemic effect by supplementing patients’ immune systems with allogeneic gamma-delta T cells to reduce relapse and improve overall survival in patients who have undergone an allogeneic HSCT. Although early, we are encouraged by data obtained to date indicating the potential for well-tolerated allogeneic gamma delta T-cell therapies. We look forward to announcing additional data on this program in 2022.”
The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose escalation trial of INB-100 in patients with leukemias undergoing haploidentical HSCT being conducted at The University of Kansas Cancer Center (KU Cancer Center). Following HSCT, each patient receives a single infusion of IN8bio’s donor-derived ex-vivo, expanded, activated gamma delta T-cells. The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival. The trial consists of three dose escalation cohorts with topline data expected in 2023.
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T-cell product candidates for solid and liquid tumors. 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 DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T-cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.
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