IN8bio Presents Positive Phase 1 Data at TCT 2025, Highlighting Durability of Remissions in High-Risk AML
IN8bio (Nasdaq: INAB) presented Phase 1 data for INB-100, its allogeneic gamma-delta T cell therapy, showing significant promise in treating high-risk acute myeloid leukemia (AML). The data revealed zero relapses in AML patients with a median follow-up of 20.1 months. The therapy demonstrated impressive outcomes with a 90.9% progression-free survival rate and 100% overall survival at one year.
The treatment showed a favorable safety profile with no cytokine release syndrome, neurotoxicity, or dose-limiting toxicities. Evidence of in vivo expansion and long-term persistence of gamma-delta T cells was observed. With approximately 20,000 new AML cases and 11,500 deaths annually in the U.S., and post-HSCT relapse occurring in up to 50% of patients, INB-100 addresses a significant unmet medical need.
The company plans to complete enrollment of the expansion cohort in 2025, with FDA confirming relapse-free survival as an acceptable primary endpoint for a future pivotal trial.
IN8bio (Nasdaq: INAB) ha presentato dati di Fase 1 per INB-100, la sua terapia cellulare allogenica a cellule T gamma-delta, mostrando un significativo potenziale nel trattamento della leucemia mieloide acuta (AML) ad alto rischio. I dati hanno rivelato zero ricadute nei pazienti con AML con un follow-up mediano di 20,1 mesi. La terapia ha dimostrato risultati impressionanti con un 90,9% di sopravvivenza libera da progressione e un 100% di sopravvivenza complessiva a un anno.
Il trattamento ha mostrato un profilo di sicurezza favorevole senza sindrome da rilascio di citochine, neurotossicità o tossicità limitante la dose. È stata osservata evidenza di espansione in vivo e persistenza a lungo termine delle cellule T gamma-delta. Con circa 20.000 nuovi casi di AML e 11.500 decessi annuali negli Stati Uniti, e la recidiva post-HSCT che si verifica in fino al 50% dei pazienti, INB-100 risponde a un significativo bisogno medico insoddisfatto.
L'azienda prevede di completare l'arruolamento del coorte di espansione nel 2025, con la FDA che conferma la sopravvivenza libera da recidive come endpoint primario accettabile per un futuro trial pivotale.
IN8bio (Nasdaq: INAB) presentó datos de Fase 1 para INB-100, su terapia con células T gamma-delta alogénicas, mostrando una promesa significativa en el tratamiento de la leucemia mieloide aguda (AML) de alto riesgo. Los datos revelaron cero recaídas en pacientes con AML con un seguimiento medio de 20,1 meses. La terapia demostró resultados impresionantes con una tasa de supervivencia libre de progresión del 90,9% y una supervivencia global del 100% a un año.
El tratamiento mostró un perfil de seguridad favorable sin síndrome de liberación de citoquinas, neurotoxicidad ni toxicidades limitantes de dosis. Se observó evidencia de expansión in vivo y persistencia a largo plazo de las células T gamma-delta. Con aproximadamente 20,000 nuevos casos de AML y 11,500 muertes anuales en los EE. UU., y la recaída post-HSCT ocurriendo en hasta el 50% de los pacientes, INB-100 aborda una necesidad médica insatisfecha significativa.
La empresa planea completar la inscripción de la cohorte de expansión en 2025, con la FDA confirmando la supervivencia libre de recaídas como un endpoint primario aceptable para un futuro ensayo pivotal.
IN8bio (Nasdaq: INAB)는 INB-100에 대한 1상 데이터를 발표했습니다. 이는 고위험 급성 골수성 백혈병(AML) 치료에 대한 상당한 가능성을 보여주는 동종 이식 감마 델타 T 세포 요법입니다. 데이터에 따르면, AML 환자에서 재발이 전혀 없었습니다 (중간 추적 관찰 기간 20.1개월). 이 요법은 90.9%의 무진행 생존율과 100%의 전체 생존율을 1년 동안 보여주는 인상적인 결과를 나타냈습니다.
치료는 사이토카인 방출 증후군, 신경독성 또는 용량 제한 독성이 없는 유리한 안전 프로필을 보였습니다. 감마 델타 T 세포의 생체 내 확장 및 장기 지속성에 대한 증거가 관찰되었습니다. 미국에서 매년 약 20,000명의 AML 신규 환자와 11,500명의 사망자가 있으며, HSCT 이후 재발이 최대 50%의 환자에게 발생하는 상황에서 INB-100은 상당한 의료적 필요를 충족합니다.
회사는 2025년까지 확장 코호트의 등록을 완료할 계획이며, FDA는 향후 주요 시험을 위한 수용 가능한 주요 목표로 재발 없는 생존을 확인했습니다.
IN8bio (Nasdaq: INAB) a présenté des données de phase 1 pour INB-100, sa thérapie cellulaire allogénique à cellules T gamma-delta, montrant une promesse significative dans le traitement de la leucémie myéloïde aiguë (LMA) à haut risque. Les données ont révélé aucune rechute chez les patients atteints de LMA avec un suivi médian de 20,1 mois. La thérapie a montré des résultats impressionnants avec un taux de survie sans progression de 90,9% et une survie globale de 100% après un an.
Le traitement a montré un profil de sécurité favorable sans syndrome de libération de cytokines, neurotoxicité ou toxicités limitantes de dose. Des preuves d'expansion in vivo et de persistance à long terme des cellules T gamma-delta ont été observées. Avec environ 20 000 nouveaux cas de LMA et 11 500 décès annuels aux États-Unis, et un risque de rechute post-HSCT pouvant atteindre 50% des patients, INB-100 répond à un besoin médical non satisfait significatif.
L'entreprise prévoit de terminer l'inscription de la cohorte d'expansion en 2025, la FDA confirmant la survie sans rechute comme un critère d'évaluation principal acceptable pour un futur essai pivot.
IN8bio (Nasdaq: INAB) hat Daten der Phase 1 für INB-100 vorgestellt, seine allogene gamma-delta T-Zelltherapie, die vielversprechende Ergebnisse bei der Behandlung von hochriskierter akuter myeloischer Leukämie (AML) zeigt. Die Daten zeigten keine Rückfälle bei AML-Patienten mit einer medianen Nachbeobachtungszeit von 20,1 Monaten. Die Therapie erzielte beeindruckende Ergebnisse mit einer 90,9% progressionsfreien Überlebensrate und 100% Gesamtüberlebensrate nach einem Jahr.
Die Behandlung zeigte ein günstiges Sicherheitsprofil ohne Zytokinfreisetzungssyndrom, Neurotoxizität oder dosierungsbegrenzende Toxizitäten. Es wurden Hinweise auf die in vivo Expansion und langfristige Persistenz von gamma-delta T-Zellen beobachtet. Mit etwa 20.000 neuen AML-Fällen und 11.500 Todesfällen jährlich in den USA und einem Rückfall nach HSCT, der bei bis zu 50% der Patienten auftritt, deckt INB-100 einen erheblichen ungedeckten medizinischen Bedarf ab.
Das Unternehmen plant, die Rekrutierung der Erweiterungsgruppe bis 2025 abzuschließen, wobei die FDA das rückfallfreie Überleben als akzeptablen primären Endpunkt für eine zukünftige entscheidende Studie bestätigt hat.
- Zero relapses in AML patients with 20.1 months median follow-up
- 90.9% progression-free survival and 100% overall survival at one year
- Favorable safety profile with no major adverse events
- FDA confirmation of relapse-free survival as acceptable primary endpoint
- None.
Insights
The Phase 1 data for INB-100 represents a potential breakthrough in AML treatment, particularly noteworthy for achieving zero relapses in treated patients over a 20.1-month median follow-up. This is extraordinary considering historical post-transplant relapse rates of up to 50% in AML patients.
The reported 90.9% progression-free survival and 100% overall survival rates at one year significantly outperform current standards. To put this in perspective, typical one-year survival rates for high-risk AML patients post-transplant range from 50-70%, making these results particularly impressive.
The clean safety profile - absence of cytokine release syndrome, neurotoxicity, or treatment-related deaths - is important as these complications often limit cellular therapy applications. This favorable safety profile, combined with evidence of gamma-delta T cell persistence and expansion, suggests potential for long-term disease control without the need for maintenance therapy.
The FDA's acceptance of relapse-free survival as a primary endpoint for future pivotal trials streamlines the regulatory pathway. This could accelerate development timelines and potentially bring this therapy to market sooner for the approximately 20,000 new AML patients diagnosed annually in the U.S.
The gamma-delta T cell approach represents a novel mechanism in cellular therapy, distinct from CAR-T and other conventional immunotherapies. These cells naturally target cancer while sparing healthy tissue, potentially offering a better therapeutic window than existing options. The demonstrated durability without maintenance therapy could significantly reduce the economic burden of AML treatment while improving patient outcomes.
NEW YORK, Feb. 14, 2025 (GLOBE NEWSWIRE) -- February 14, 2025 – IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, yesterday presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii. 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.
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
“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 at100% . - 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
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.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. 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 AML evaluating haplo-matched allogeneic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma. For more information about IN8bio, visit www.IN8bio.com.
Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: IN8bio’s ability to deliver on the potential of INB-100; the potential of allogeneic INB-100 gamma-delta T cells to provide durable long-term, relapse-free remissions in high-risk or relapsed AML patients undergoing HSCT; the ability of INB-100 to help preserve the quality of life of AML patients and to become an attractive cellular therapy with the potential to extend survival in this difficult-to-treat patient population; IN8bio’s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials, enrollment of additional patients in its clinical trials, and advancement of clinical development plans; IN8bio’s ability to de-risk INB-100’s path toward a potential registrational trial and achieve future approval and broader patient access; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Investors & Company Contacts:
Glenn Schulman, PharmD, MPH
203.494.7411
gdschulman@in8bio.com
IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com
Media Contact
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FAQ
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