IN8bio Presents Data at ISCT 2025 Demonstrating Proprietary γδ T cell Manufacturing Generates Consistent and Robust Clinical Products
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.
IN8bio (NASDAQ: INAB) ha presentato nuovi dati sul suo programma proprietario di produzione di cellule T gamma-delta (γδ) al congresso ISCT 2025, ricevendo il premio Host Region Abstract Award. Il processo di produzione DeltEx™ Allo dell'azienda ha dimostrato una produzione costante di terapie cellulari potenti per il trattamento del cancro.
I risultati principali dello studio INB-100 hanno evidenziato: (1) la riuscita riprogrammazione del recettore TCR da αβ a γδ in tutti i lotti clinici, (2) un'elevata espressione di geni legati all'eliminazione del cancro e all'attivazione immunitaria, e (3) risultati clinici straordinari con tutti i 10 pazienti della coorte iniziale senza recidive per oltre un anno, raggiungendo una sopravvivenza globale mediana di 23,3 mesi a gennaio 2024.
L'azienda ha automatizzato il suo programma di produzione per una realizzazione rapida e riproducibile di dosi di terapia cellulare criopreservate. Il trial INB-100 sta attualmente reclutando una coorte di espansione alla dose raccomandata per la Fase 2.
IN8bio (NASDAQ: INAB) presentó nuevos datos sobre su programa propietario de fabricación de células T gamma-delta (γδ) en ISCT 2025, recibiendo el premio Host Region Abstract Award. El proceso de fabricación DeltEx™ Allo de la compañía demostró una producción constante de terapias celulares potentes para el tratamiento del cáncer.
Los hallazgos clave del estudio INB-100 revelaron: (1) Reprogramación exitosa del TCR de αβ a γδ en todos los lotes clínicos, (2) Alta expresión de genes relacionados con la destrucción del cáncer y la activación inmune, y (3) Resultados clínicos notables con los 10 pacientes iniciales de la cohorte sin recaídas por más de un año, alcanzando una supervivencia global mediana de 23,3 meses a enero de 2024.
La compañía ha automatizado su programa de fabricación para una producción rápida y reproducible de dosis de terapia celular criopreservadas. El ensayo INB-100 está actualmente reclutando una cohorte de expansión con la dosis recomendada para la Fase 2.
IN8bio(NASDAQ: INAB)는 ISCT 2025에서 자사의 독자적인 감마-델타(γδ) T 세포 제조 프로그램에 대한 새로운 데이터를 발표하며 Host Region Abstract Award를 수상했습니다. 회사의 DeltEx™ Allo 제조 공정은 암 치료를 위한 강력한 세포 치료제의 일관된 생산을 입증했습니다.
INB-100 연구의 주요 결과는 다음과 같습니다: (1) 모든 임상 배치에서 αβ에서 γδ로의 TCR 재프로그래밍 성공, (2) 암 세포 살상 및 면역 활성화 유전자의 높은 발현, (3) 놀라운 임상 결과로 초기 10명 환자 모두 1년 이상 재발 없이 유지되었으며, 2024년 1월 기준 중앙 전체 생존 기간 23.3개월을 기록했습니다.
회사는 냉동 보존된 세포 치료제의 빠르고 재현 가능한 생산을 위해 제조 프로그램을 자동화했습니다. INB-100 임상시험은 현재 권장된 2상 용량으로 확장 코호트를 모집 중입니다.
IN8bio (NASDAQ : INAB) a présenté de nouvelles données sur son programme propriétaire de fabrication de cellules T gamma-delta (γδ) lors de l'ISCT 2025, recevant le prix Host Region Abstract Award. Le processus de fabrication DeltEx™ Allo de la société a démontré une production constante de thérapies cellulaires puissantes pour le traitement du cancer.
Les principales conclusions de l'étude INB-100 ont révélé : (1) Reprogrammation réussie du TCR de αβ à γδ dans tous les lots cliniques, (2) Forte expression des gènes liés à la destruction du cancer et à l'activation immunitaire, et (3) Résultats cliniques remarquables avec les 10 patients initiaux de la cohorte restant sans rechute depuis plus d'un an, atteignant une survie globale médiane de 23,3 mois en janvier 2024.
L'entreprise a automatisé son programme de fabrication pour une production rapide et reproductible de doses de thérapie cellulaire cryoconservées. L'essai INB-100 recrute actuellement une cohorte d'expansion à la dose recommandée pour la phase 2.
IN8bio (NASDAQ: INAB) präsentierte neue Daten zu seinem proprietären Gamma-Delta (γδ) T-Zell-Herstellungsprogramm auf der ISCT 2025 und erhielt den Host Region Abstract Award. Der firmeneigene DeltEx™ Allo Herstellungsprozess zeigte eine konsistente Produktion potenter Zelltherapien zur Krebsbehandlung.
Wesentliche Erkenntnisse aus der INB-100-Studie zeigten: (1) Erfolgreiche TCR-Umschaltung von αβ auf γδ in allen klinischen Chargen, (2) Hohe Expression von krebsbekämpfenden und immunaktivierenden Genen, und (3) Bemerkenswerte klinische Ergebnisse mit allen 10 Patienten der Anfangskohorte, die über ein Jahr rückfallfrei blieben, und einer medianen Gesamtüberlebenszeit von 23,3 Monaten bis Januar 2024.
Das Unternehmen hat sein Herstellungsprogramm automatisiert, um eine schnelle und reproduzierbare Produktion kryokonservierter Zelltherapiedosen zu gewährleisten. Die INB-100-Studie rekrutiert derzeit eine Erweiterungskohorte mit der empfohlenen Phase-2-Dosis.
- 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
- None.
Insights
IN8bio's proprietary manufacturing process creates consistent γδ T cells showing promising durability in AML patients with 100% relapse-free at 1+ year.
IN8bio's presentation at ISCT 2025 reveals significant advancements in their γδ T cell manufacturing capabilities, earning them the Host Region Abstract Award. Their proprietary DeltEx™ Allo manufacturing process has demonstrated a remarkable ability to consistently reprogram donor T cells to express γδ T cell receptors with enhanced cancer-killing properties, regardless of donor variability.
What's particularly impressive from a clinical perspective is the durability of response in their INB-100 trial for acute myeloid leukemia (AML) patients. The 100% relapse-free rate beyond one year in the initial cohort of 10 patients is exceptional for high-risk AML, where recurrence typically occurs within 6-12 months. The median overall survival of 23.3 months further supports the potential therapeutic value.
The persistence of the allogeneic γδ T cells for up to a year represents a significant breakthrough. Most allogeneic (donor-derived) cell therapies are rapidly cleared by the recipient's immune system, limiting their effectiveness. This extended persistence suggests the cells are evading immune rejection while maintaining anti-cancer activity.
The company's control over the entire manufacturing process provides them a strategic advantage in the competitive cell therapy landscape. Their automation of the manufacturing process and ability to create cryopreserved doses will be crucial for scaling to meet potential commercial demands. The expansion cohort enrollment at the recommended Phase 2 dose indicates progressive clinical development, though investors should monitor whether these impressive early results maintain consistency in larger patient populations.
From an oncology perspective, these data suggest IN8bio's approach could address key limitations of current cellular therapies for blood cancers, potentially offering a more accessible and durable treatment option for AML patients with poor prognosis.
- 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
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