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IN8bio Expands INB-100 Phase 1 Clinical Trial with Addition of The Ohio State University as New Site

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IN8bio (Nasdaq: INAB) announced that The Ohio State University has been added as a new clinical site in the ongoing Phase 1 trial of INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients receiving haploidentical stem cell transplants for leukemia.

The company said the addition aims to accelerate enrollment of the expansion cohort and deliver follow-up data next year. IN8bio noted clinical observations including long-term leukemic remissions beyond four and five years in earliest-treated patients, persistence and expansion of INB-100 up to 1 year, and an absence of severe graft-versus-host disease in presented data. Trial identifier: NCT03533816.

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Positive

  • Added The Ohio State University as a trial site to accelerate enrollment
  • Company expects follow-up data from expansion cohort in 2026
  • Earliest-treated patients report >4–5 years relapse-free remissions
  • INB-100 persistence and expansion observed up to 1 year
  • No severe graft-versus-host disease reported in presented data

Negative

  • Trial remains Phase 1, limiting definitive efficacy and regulatory conclusions
  • Enrollment and pivotal data timelines depend on multiple sites and remain uncertain

News Market Reaction – INAB

-4.76%
1 alert
-4.76% News Effect

On the day this news was published, INAB declined 4.76%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

NEW YORK, Oct. 29, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today announced that The Ohio State University has been added as a new clinical site in the ongoing Phase 1 trial of the Company’s INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients with leukemias undergoing haploidentical stem cell transplantation.

The addition of this leading academic institution reflects a strong interest in INB-100 and supports the ongoing efforts to accelerate enrollment and complete this Phase 1 trial.

“This trial is an excellent opportunity to explore a strategy aimed at reducing the risk of graft-versus-host disease and the risk of relapse following haploidentical stem cell transplant,” said Sarah A. Wall, M.D., Investigator and Assistant Professor in the College of Medicine at The Ohio State University. “The increased use of haploidentical donors in the last decade has created more access to potentially life-saving allogeneic transplants for many patients, particularly under-represented groups who are less likely to have fully matched donors. I am incredibly excited to be opening and leading this trial at The James Comprehensive Cancer Center at Ohio State University.”

“We are excited to welcome The Ohio State University as a clinical partner in the INB-100 study,” said William Ho, CEO and co-founder of IN8bio. “With multiple sites actively screening, we look forward to completing the enrollment of the expansion cohort and providing follow-up data next year. INB-100 continues to demonstrate the potential of gamma-delta T cells to improve outcomes and reduce relapse in patients following stem cell transplantation. Multiple patients with complex, high-risk disease continue to demonstrate long-term leukemic remissions with the earliest treated patients now beyond four- and five-years relapse-free.”

The INB-100 trial is being run by Principal Investigator Dr. Joseph P. McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics, Medical Director, Blood and Marrow Transplant at the Kansas University Cancer Center (KUCC). The trial is designed to evaluate the safety, durability, and anti-leukemic activity of IN8bio’s allogeneic gamma-delta T cell therapy in the post-transplant setting. The Company has previously presented clinical data demonstrating encouraging long-term survival outcomes relative to real-world historical data, immune reconstitution including expansion and persistence of the allogenic INB-100 gamma-delta T cell therapy up to 1-year post treatment, and absence of severe graft-versus-host disease.

For more information about the study NCT03533816, visit clinicaltrials.gov

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell-based immunotherapies for cancer and autoimmune diseases. 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. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma, and advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com.

Contacts:

IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com

Media Contact:
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com


FAQ

What did IN8bio announce about the INB-100 Phase 1 trial on October 29, 2025?

IN8bio added The Ohio State University as a new clinical site to the INB-100 Phase 1 trial to help accelerate enrollment.

How does the Ohio State site affect IN8bio (INAB) trial timelines?

The company said the new site supports faster enrollment and aims to provide expansion-cohort follow-up data next year.

What clinical outcomes has IN8bio reported for INB-100 in the post-transplant setting?

Reported observations include long-term remissions beyond four and five years, persistence and expansion of INB-100 up to 1 year, and an absence of severe graft-versus-host disease.

Who is running the INB-100 Phase 1 trial (NCT03533816)?

Principal Investigator is Dr. Joseph P. McGuirk at Kansas University Cancer Center, with The James Comprehensive Cancer Center at Ohio State added as a new site.

Does the October 29, 2025 announcement include financial details or guidance for IN8bio (INAB)?

No. The announcement focuses on the new clinical site and clinical observations and does not include financial metrics or guidance.
In8Bio, Inc.

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