IN8bio Completes Dosing of First Cohort in Phase 1 Clinical Trial with Allogeneic Gamma Delta T-Cell Therapy in Leukemia Patients Undergoing Hematopoietic Stem Cell Transplant

New York, New York, UNITED STATES


The first cohort has completed dosing with IN8bio’s donor derived allogeneic gamma delta T-cell product candidate, INB-100, with no severe adverse infusion reactions or dose limiting toxicities (DLTs) observed to date

The first two patients continue to be in complete remission more than one year following INB-100 dosing

NEW YORK, Aug. 11, 2021 (GLOBE NEWSWIRE) -- 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, today 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.

About IN8bio
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.

Forward Looking Statements
Certain statements herein concerning the Company’s future expectations, plans and prospects, including without limitation, the Company’s current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company’s control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Company’s current expectations include: scientific, regulatory and technical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; and the Company’s reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.

Company Contact:
IN8bio, Inc.
Kate Rochlin, Ph.D.
+1 646.600.6GDT (6438)
info@IN8bio.com

Investors:
Solebury Trout
Nicholas Colangelo
+ 1 646.378.2929
ncolangelo@troutgroup.com

Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D. / Harrison Wong
+1 212.213.0006 - ext. 364 / 316
rflamm@burnsmc.com / hwong@burnsmc.com