On February 14, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii (Press release, In8bio, FEB 14, 2025, View Source [SID1234650285]). The data, previously announced, reinforce INB-100’s potential to significantly reduce post-transplant relapse in high-risk acute myeloid leukemia (AML) patients, positioning this gamma-delta T cell therapy as a promising approach in hematologic oncology.

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The latest findings demonstrate that INB-100 continues to deliver long-term remissions, with no AML patient relapses observed to date with a median follow-up of 20.1 months. The 1-year progression-free survival (PFS) rate across all leukemia patients stands at 90.9%, and 1-year overall survival (OS) is 100%, outperforming real-world historical controls. These data demonstrate that results for INB-100 do not appear to be due to imbalances in patient selection criteria, the performance of the individual clinical centers or driven by specific transplant or lymphodepletion protocols. These data underscore INB-100’s potential to reshape post-transplant care by leveraging gamma-delta T cells to enable sustained cancer cell surveillance and long-term remissions.

"AML patients undergoing allogeneic HSCT face high relapse rates with limited post-transplant therapeutic options," said William Ho, Chief Executive Officer and co-founder of IN8bio. "The durability of response and safety profile observed to date with INB-100 support its potential to set a new standard in post-transplant leukemia management."

"Despite decades of progress in transplantation, relapse remains the primary driver of mortality in AML patients post-HSCT. The INB-100 data showing durable remission without maintenance therapy is highly encouraging," said Dr. Michael Bishop, Director of the Hematopoietic Cellular Therapy Program, Director of the David and Etta Jonas Center for Cellular Therapy, and Professor of Medicine at the University of Chicago and IN8bio Scientific Advisory Board member.

Key Phase 1 INB-100 Findings:

Zero Relapses in AML Patients: No relapses observed in any AML patient treated with INB-100, with a median follow-up of over 20 months.
Superior 1-Year Survival Rates: PFS at 90.9%, OS at 100%.
Favorable Safety Profile: No cytokine release syndrome (CRS), neurotoxicity (ICANS), or Dose Limiting Toxicities (DLT’s). No treatment-related deaths.
Gamma Delta T Cell Persistence and Expansion: Evidence of in vivo expansion and long-term persistence, reinforcing the therapy’s potential to maintain immune surveillance against residual leukemic cells.
With approximately 20,000 new AML cases and ~11,500 deaths annually in the U.S., AML remains an area of high unmet medical need. Post-HSCT relapse occurs in up to 50% of patients, highlighting the urgency for novel, more durable therapeutic approaches. INB-100 harnesses the innate tumor-targeting properties of gamma-delta T cells to improve long-term outcomes, potentially filling a critical treatment gap.

IN8bio is accelerating patient enrollment in the INB-100 program and expects to complete enrollment of the expansion cohort in 2025. The company’s FDA discussions confirmed that relapse-free survival (RFS) is an acceptable primary endpoint for a future potentially pivotal randomized controlled trial in AML patients.

IN8bio recently hosted a Key Opinion Leader webinar discussing the latest developments in gamma-delta T cell therapy and the promising INB-100 clinical data. The webinar featured insights including Dr. Michael Bishop. A replay of the February 11, 2025 webinar is accessible here on the company’s website.