IN8bio Presents Data at ISCT 2025 Demonstrating Proprietary γδ T cell Manufacturing Generates Consistent and Robust Clinical Products

Rhea-AI Summary

IN8bio (NASDAQ: INAB) presented new data on its proprietary gamma-delta (γδ) T cell manufacturing program at ISCT 2025, receiving the Host Region Abstract Award. The company's DeltEx™ Allo manufacturing process demonstrated consistent production of potent cellular therapies for cancer treatment.

Key findings from the INB-100 study revealed: (1) Successful TCR reprogramming from αβ to γδ across all clinical batches, (2) High expression of cancer-killing and immune activation genes, and (3) Remarkable clinical outcomes with all 10 initial cohort patients remaining relapse-free for over a year, achieving a median overall survival of 23.3 months as of January 2024.

The company has automated its manufacturing program for rapid, reproducible production of cryopreserved cell therapy doses. The INB-100 trial is currently enrolling an expansion cohort at the recommended Phase 2 dose.

Positive

• All 10 patients in initial cohort remained relapse-free for over one year
• Median overall survival of 23.3 months in AML patients
• Manufacturing process successfully automated for rapid and reproducible production
• Long-term expansion and persistence of γδ T cells observed through 1 year - first time for an allogeneic cellular therapy
• Received prestigious Host Region Abstract Award, validating technology excellence

Negative

• None.

• Company receives ISCT abstract award for the analytical characterization of its manufactured gamma-delta T cell therapies in the INB-100 trial, which has demonstrated durable, relapse-free survival in AML patients.
  
  
• IN8bio’s proprietary gamma-delta T cell manufacturing platform generates robust and reproducible products that are activated and primed for tumor cell killing, migration and immune cell recruitment.
  

NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, today announced new data on its proprietary γδ T manufacturing program. The oral presentation shared exciting updates about its unique manufacturing processes, including deep analytics, genomics and repertoire analysis, presented at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. The data, which earned IN8bio the prestigious Host Region (U.S. East) Abstract Award, as presented by Bruce Levine, PhD, ISCT Past President and a member of IN8bio’s Scientific Advisory Board. The award is a competitive recognition for scientific excellence and demonstrates how IN8bio’s technology and know-how creates consistent, powerful cellular therapies.

The oral presentation highlights how IN8bio’s DeltEx™ Allo manufacturing process consistently induces donor derived T cells to express γδ T cell receptors (TCRs) and genes, associated with increased cancer cytotoxicity. Gene expression profiling confirmed a highly potent product across multiple manufacturing batches.

“Manufacturing abilities are paramount to the successful and safe development of cellular therapies. From process development through clinical manufacturing and product characterization, IN8bio uniquely maintains hands-on control of all steps in the process. These data and the Abstract Award further establish IN8bio as a leader in clinical grade γδ T cell manufacturing,” said Kate Rochlin, Chief Operating Officer of IN8bio. “The power of our platform is our ability to consistently produce robust cell products with signatures associated with cytotoxicity, immune activation, and tissue trafficking. Our knowledge and know-how are key differentiators as we efficiently scale manufacturing to support our clinical trials and potential future commercialization.”

Key Findings from the INB-100 Study Presented at ISCT:

• Manufacturing-Driven TCR Reprogramming: All analyzed clinical batches showed a clear and consistent shift from αβ-TCR to γδ-TCR dominance, with enrichment of Vγ9 clones. This shift occurred independent of donor starting material, indicating the process—not the donor—drives final TCR composition.
• Uniform Potency Markers Across Donors: All manufactured clinical products showed high expression levels of genes linked to increased cancer killing, immune activation, and tumor seeking migration.
• Durable Remissions in AML Patients: All 10 patients in the initial cohort remained relapse-free for more than one year, with a median overall survival of 23.3 months as of January 2024.
  
  

These results highlight the strength and reproducibility of IN8bio’s cell therapy manufacturing processes. These products were administered clinically in the INB-100 clinical trial, which has demonstrated durable long-term remissions in adult AML patients with high-risk, complex disease characteristics. Further, long term expansion and persistence of the γδ T cells have been observed in these patients through 1 year, a first for an allogeneic cellular therapy product. IN8bio‘s manufacturing program has been automated, enabling rapid and reproducible production of cryopreserved cell therapy doses. The INB-100 trial continues to enroll an expansion cohort at the recommended Phase 2 dose (RP2D).

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 are the clinical results of IN8bio's (INAB) INB-100 trial in AML patients?

All 10 patients in the initial cohort remained relapse-free for over one year, with a median overall survival of 23.3 months as of January 2024. The trial demonstrated long-term expansion and persistence of γδ T cells through 1 year.

What is unique about IN8bio's (INAB) DeltEx™ Allo manufacturing process?

The process consistently transforms αβ-TCR to γδ-TCR dominance, independent of donor material, and produces cells with high expression of cancer-killing and immune activation genes. The process has been automated for rapid, reproducible production.

What recognition did IN8bio (INAB) receive at ISCT 2025?

IN8bio received the prestigious Host Region (U.S. East) Abstract Award at ISCT 2025 for their analytical characterization of manufactured gamma-delta T cell therapies in the INB-100 trial.

What is the current status of IN8bio's (INAB) INB-100 clinical trial?

The INB-100 trial is currently enrolling an expansion cohort at the recommended Phase 2 dose (RP2D), following successful results in the initial cohort.