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IN8bio Reports Continued Progression-Free Survival in Phase 1 Investigator-Sponsored Trial of INB-100 Allogeneic Gamma-Delta T Cells for Leukemias at the 2024 American Society of Hematology Annual Meeting

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IN8bio reported updated data from its Phase 1 trial of INB-100, an allogeneic gamma-delta T cell therapy for leukemia patients. Key highlights include:

- All patients (n=10) maintained complete remission (CR) with no relapses after a median follow-up of 19.7 months

- Three high-risk cytogenetic AML patients remained in CR for over three years without maintenance therapy

- The therapy showed durable in vivo expansion and persistence of allogeneic gamma-delta T cells for 365 days post-administration

- Safety profile remained favorable with no cytokine release syndrome or neurotoxicity

The trial enrolled patients with median age 68 years, mostly diagnosed with AML in CR1. Based on positive results, the trial has been expanded with additional patient enrollment at Dose Level 2, with new data expected in H1 2025.

IN8bio ha riportato dati aggiornati dal suo studio di Fase 1 su INB-100, una terapia con cellule T gamma-delta allogeniche per pazienti affetti da leucemia. I punti salienti includono:

- Tutti i pazienti (n=10) hanno mantenuto una remissione completa (CR) senza recidive dopo un follow-up mediano di 19,7 mesi

- Tre pazienti con AML citogenetica ad alto rischio sono rimasti in CR per oltre tre anni senza terapia di mantenimento

- La terapia ha mostrato un'espansione in vivo duratura e una persistenza delle cellule T gamma-delta allogeniche per 365 giorni dopo la somministrazione

- Il profilo di sicurezza è rimasto favorevole, senza sindrome da rilascio di citochine o neurotossicità

Lo studio ha arruolato pazienti con un'età media di 68 anni, per lo più diagnosticati con AML in CR1. Sulla base dei risultati positivi, lo studio è stato ampliato con ulteriori arruolamenti di pazienti a Dose Level 2, con nuovi dati attesi nel primo semestre del 2025.

IN8bio informó datos actualizados de su ensayo de Fase 1 de INB-100, una terapia con células T gamma-delta alogénicas para pacientes con leucemia. Los aspectos destacados incluyen:

- Todos los pacientes (n=10) mantuvieron una remisión completa (CR) sin recaídas después de un seguimiento mediano de 19.7 meses

- Tres pacientes con AML citogenética de alto riesgo permanecieron en CR durante más de tres años sin terapia de mantenimiento

- La terapia mostró una expansión in vivo duradera y persistencia de células T gamma-delta alogénicas durante 365 días después de la administración

- El perfil de seguridad se mantuvo favorable, sin síndrome de liberación de citoquinas ni neurotoxicidad

El ensayo inscribió pacientes con una edad media de 68 años, en su mayoría diagnosticados con AML en CR1. Basado en los resultados positivos, el ensayo se ha ampliado con más inscripciones de pacientes en el Nivel de Dosis 2, con nuevos datos esperados en el primer semestre de 2025.

IN8bio는 백혈병 환자를 위한 동종 감마-델타 T 세포 치료제 INB-100의 1상 임상시험의 업데이트된 데이터를 보고했습니다. 주요 하이라이트는 다음과 같습니다:

- 모든 환자(n=10)는 19.7개월의 중앙 추적 관찰 기간 동안 재발 없이 완전 관해(CR)를 유지했습니다.

- 3명의 고위험 세포유전학적 AML 환자는 유지 치료 없이 3년 이상 CR을 유지했습니다.

- 치료는 약물 투여 후 365일 동안 동종 감마-델타 T 세포의 지속적인 생체 내 확장 및 지속성을 보여주었습니다.

- 안전성 프로필은 사이토카인 방출 증후군이나 신경 독성이 나타나지 않아 유리하게 유지되었습니다.

재판은 중앙 연령 68세의 환자를 등록했으며, 대부분 CR1로 진단된 AML 환자입니다. 긍정적인 결과에 따라, 임상시험은 추가 환자 등록이 이루어진 2단계 용량으로 확대되었으며, 새로운 데이터는 2025년 상반기에 예상됩니다.

IN8bio a rapporté des données mises à jour de son essai de Phase 1 sur INB-100, une thérapie par cellules T gamma-delta allogéniques pour les patients atteints de leucémie. Les principaux points forts incluent:

- Tous les patients (n=10) ont maintenu une rémission complète (CR) sans rechute après un suivi médian de 19,7 mois

- Trois patients AML à haut risque cytogénétique sont restés en CR pendant plus de trois ans sans thérapie de maintien

- La thérapie a montré une expansion in vivo durable et une persistance des cellules T gamma-delta allogéniques pendant 365 jours après l'administration

- Le profil de sécurité est resté favorable, sans syndrome de libération de cytokines ni neurotoxicité

L'essai a recruté des patients ayant un âge médian de 68 ans, pour la plupart diagnostiqués avec AML en CR1. Sur la base des résultats positifs, l'essai a été étendu avec un recrutement supplémentaire de patients au Niveau de Dose 2, avec de nouvelles données attendues au premier semestre 2025.

IN8bio hat aktualisierte Daten aus seiner Phase-1-Studie zu INB-100, einer allogenen gamma-delta T-Zelltherapie für Leukämiepatienten, berichtet. Die wichtigsten Highlights sind:

- Alle Patienten (n=10) hielten eine komplette Remission (CR) ohne Rückfälle nach einer medianen Nachbeobachtungszeit von 19,7 Monaten aufrecht

- Drei Patienten mit hochriskanter zytogenetischer AML behielten die CR über drei Jahre lang ohne Erhaltungstherapie

- Die Therapie zeigte eine dauerhafte in-vivo-Erweiterung und Persistenz von allogenen gamma-delta T-Zellen 365 Tage nach der Verabreichung

- Das Sicherheitsprofil blieb günstig, ohne Syndrom der Zytokinfreisetzung oder Neurotoxizität

Die Studie rekrutierte Patienten mit einem Durchschnittsalter von 68 Jahren, von denen die meisten mit AML in CR1 diagnostiziert wurden. Basierend auf positiven Ergebnissen wurde die Studie mit zusätzlicher Patientenrekrutierung auf Dosisstufe 2 ausgeweitet, wobei neue Daten im ersten Halbjahr 2025 erwartet werden.

Positive
  • 100% survival rate in all patients (n=10) beyond one-year post-treatment
  • No relapses observed in any AML patients after median 19.7 months follow-up
  • Three high-risk patients maintained CR for over three years without maintenance therapy
  • First-ever demonstration of durable persistence of allogeneic cellular therapy for 365 days
  • Well-tolerated safety profile with no major adverse events
Negative
  • One patient death at 15.5 months due to pulmonary syndrome related to HSCT
  • 60% of patients experienced low-grade acute GvHD
  • 20% of patients experienced Grade 3 nausea

Insights

The Phase 1 trial results for INB-100 demonstrate remarkable efficacy in treating acute myeloid leukemia (AML) patients. The 100% complete remission rate after a median 19.7 months follow-up is exceptional, particularly given the historical context where 25% of patients typically relapse within 100 days and up to 50% within a year. The therapy's ability to show durable in vivo expansion and persistence of allogeneic gamma-delta T cells through 365 days is groundbreaking in cellular therapy. The safety profile is notably strong with no cytokine release syndrome or neurotoxicity. Three high-risk patients maintaining complete remission beyond three years without maintenance therapy is particularly significant, suggesting potential long-term durability of response.

For IN8bio (INAB), this clinical data represents a significant value catalyst. The exceptional durability of response and safety profile positions INB-100 as a potentially transformative therapy in the lucrative blood cancer market. The 100% survival rate beyond one year substantially exceeds current standards of care, suggesting strong commercial potential if approved. With expansion cohort data expected in H1 2025, there's a clear near-term catalyst pathway. The therapy's unique mechanism of action and first-ever demonstration of durable persistence in allogeneic cellular therapy could attract partnership interest from larger pharmaceutical companies, particularly given the 23.7M market cap suggesting significant undervaluation relative to the potential market opportunity.
  • INB-100 continues to demonstrate durable complete remissions (CR) with no relapses observed in any acute myeloid leukemia (AML) patients including those with high-risk disease after a median follow-up of 19.7 months.
  • Data highlights INB-100’s long-term impact, exhibiting durable in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100, demonstrating the first-ever durable persistence and expansion of an allogeneic cellular therapy.
  • New clinical data, including results from the INB-100 expansion cohort and control data, expected to be available in the first half of 2025.

NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced updated data from the ongoing Phase 1 trial of INB-100, an allogeneic, haploidentical gamma-delta T cell therapy in older patients with hematologic malignancies undergoing haploidentical stem cell transplant (HSCT) with reduced intensity conditioning (RIC) at the 2024 American Society of Hematology (ASH) Annual Meeting, being hosted in San Diego, CA.

“This data demonstrates the potential of allogeneic INB-100 gamma-delta T cells to provide durable relapse-free remissions in high-risk or relapsed AML patients undergoing HSCT,” said Dr. Joseph P. McGuirk, Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics Medical Director, Blood and Marrow Transplant, The University of Kansas Cancer Center. “Older, frailer patients who receive non-myeloablative, reduced intensity conditioning regimens typically have a significant risk of relapse. Historically, approximately 25% of AML patients undergoing HSCT would be expected to have a leukemic relapse within the first 100 days post-transplant, with up to nearly 50% of such patients experiencing relapse by one-year, which remains the primary cause of death. The longer AML patients remain in remission post-HSCT, the greater their probability of survival. These observed long-term durable remissions using allogeneic gamma-delta T cells are very encouraging and we look forward to announcing additional data next year.”

In a poster presentation, IN8bio reported that there have been no newly reported deaths or relapses as of September 30, 2024. As of that cutoff date, median CR was at 16.4 months following a median of 19.2 months of follow-up. As previously reported, all patients (n=10) remained alive, progression-free, and in durable CR through one-year. 100% of AML patients remain in CR after a median 19.7 months of follow-up with three patients with high-risk cytogenetic AML and receiving no maintenance therapy remaining in mCR for greater than three years.

INB-100 continues to demonstrate in vivo expansion and persistence of an haplo-matched allogeneic, or donor-derived cellular, therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival. The persistence of these cells is suggestive of continued gamma-delta T cell surveillance against leukemic relapse.

In addition to the reported complete responses, INB-100 continued to demonstrate a well-tolerated safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) observed and limited mild infections. Based upon these encouraging results, the INB-100 trial has been expanded to enroll additional patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D). Enrollment of additional patients into the expansion cohort is on-going and updated data, are expected to be reported in the first half of 2025.

Summary of Data Presented at ASH

The Phase 1 investigator-sponsored trial enrolled and treated ten patients at one of two dose levels (D1 or D2). The median age was 68 years with the majority of patients diagnosed with AML in CR1. Two patients (009 and 011) had TP53 mutations, a tumor suppressor that results in poor prognosis, rapid progression and reduced lifespan due to an inability to respond to mutated or damaged DNA.

The latest INB-100 trial data on immune reconstitution continues to show significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment. As of September 30, 2024, 100% of patients (n=10) surpassed one-year survival following their haplo-matched transplant and treatment with INB-100. Historically, approximately 25% of patients relapse by 100 days and 40-50% of patients relapse by one year.

Updated safety data includes:

  • No dose limiting toxicities (DLTs) and no treatment related deaths were observed.
  • Low grade (1-2) acute graft versus host disease (GvHD) observed in 60% of patients treated. Cases were all steroid responsive.
  • Treatment-related serious adverse events included Grade 2 rash (60%) and Grade 3 nausea (20%).
  • One patient death previously reported due to idiopathic pulmonary syndrome likely related to the underlying HSCT at 15.5 months, without disease progression.
  • No ICAN, CRS, or major infections were observed.
  • Seven patients across DL 1 and DL 2 remained on study and in CR, with three having surpassed three years, including one now remaining progression free for over four years.

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 relapse-free remissions in high-risk or relapsed AML patients undergoing HSCT; 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; 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
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com


FAQ

What are the latest survival rates for INB-100 (INAB) in AML patients?

As of September 2024, 100% of patients (n=10) achieved one-year survival with no relapses after a median follow-up of 19.7 months.

What is the safety profile of INB-100 (INAB) in the Phase 1 trial?

INB-100 showed no cytokine release syndrome, neurotoxicity, or major infections. Main adverse events included Grade 1-2 GvHD (60%) and Grade 3 nausea (20%).

When will IN8bio (INAB) release new clinical data for INB-100?

IN8bio expects to report new clinical data from the INB-100 expansion cohort in the first half of 2025.

How long does INB-100 (INAB) persist in patients after treatment?

INB-100 demonstrated durable in vivo expansion and persistence of allogeneic gamma-delta T cells for 365 days following a single administration.

IN8bio, Inc.

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