IN8bio Presents Clinical Update from the Ongoing Phase 1 Trial of INB-100, an Allogeneic Gamma-Delta T Cell Therapy in Leukemia Patients Undergoing Hematopoietic Stem Cell Transplant

• All three patients with high-risk or relapsed acute-myeloid leukemia (AML) dosed to-date with INB-100 demonstrated durable remissions at 23.3, 21.0, and 9.3 months post-BMT, respectively.

• Immune systems robustly reconstituted in patients at six months post-treatment with INB-100, including T cells, B cells, and gamma-delta T cells.

• Safety profile continues to be manageable with no dose-limiting toxicities, no treatment-related Grade 3 or greater adverse events, including graft versus host disease (GvHD), and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).

• Update was presented at the European Society for Blood and Marrow Transplantation (EBMT) 48^th Annual Meeting
  

NEW YORK, March 28, 2022 (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, presented a clinical update from the ongoing Phase 1 trial of INB-100. 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.

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) 48^th 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.

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
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Contacts
IN8bio, Inc.
Kate Rochlin, Ph.D.
+1 646.600.6438
kmrochlin@in8bio.com

Investors:
Solebury Trout
David Buck
+1 646.378.2927
dbuck@soleburytrout.com

Media:
Burns McClellan, Inc.
Katie Larch / Robert Flamm, Ph.D.
klarch@burnsmc.com / rflamm@burnsmc.com