GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies
GT Biopharma (NASDAQ: GTBP) has announced the dosing of its first patient in a Phase 1 trial of GTB-3650, its second-generation TriKE therapy, for treating relapsed or refractory CD33 expressing hematologic malignancies. The trial will evaluate up to 14 patients across seven cohorts, focusing on conditions including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
GTB-3650, utilizing camelid nanobody technology, will be administered in two-week blocks (two weeks on, two weeks off) for up to four months. The study aims to assess safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity. Initial data from this Phase 1 trial is expected in 2025.
GT Biopharma (NASDAQ: GTBP) ha annunciato il trattamento del suo primo paziente in una fase 1 dello studio clinico di GTB-3650, la sua terapia TriKE di seconda generazione, per il trattamento di neoplasie ematologiche recidivanti o refrattarie che esprimono CD33. Lo studio valuterà fino a 14 pazienti suddivisi in sette cohorti, focalizzandosi su condizioni come la leucemia mieloide acuta refrattaria (AML) e la sindrome mielodisplastica ad alto rischio (MDS).
GTB-3650, che utilizza la tecnologia dei nanobody dei camelidi, sarà somministrato in blocchi di due settimane (due settimane di trattamento, due settimane di pausa) per un massimo di quattro mesi. Lo studio mira a valutare sicurezza, farmacocinetica, farmacodinamica, espansione delle cellule NK e attività clinica. I dati iniziali di questo studio di fase 1 sono attesi per il 2025.
GT Biopharma (NASDAQ: GTBP) ha anunciado la dosificación de su primer paciente en un ensayo de fase 1 de GTB-3650, su terapia TriKE de segunda generación, para el tratamiento de malignidades hematológicas CD33 que son recidivantes o refractarias. El ensayo evaluará hasta 14 pacientes a través de siete cohortes, centrándose en condiciones como la leucemia mieloide aguda refractaria (AML) y el síndrome mielodisplásico de alto riesgo (MDS).
GTB-3650, que utiliza la tecnología de nanobodies de camelidos, se administrará en bloques de dos semanas (dos semanas de tratamiento, dos semanas de descanso) durante un máximo de cuatro meses. El estudio tiene como objetivo evaluar la seguridad, farmacocinética, farmacodinámica, expansión de células NK y actividad clínica. Se espera que los datos iniciales de este ensayo de fase 1 estén disponibles en 2025.
GT Biopharma (NASDAQ: GTBP)는 재발성 또는 불응성 CD33 발현 혈액 악성 종양 치료를 위한 2세대 TriKE 요법인 GTB-3650의 1상 시험에서 첫 환자 투여를 발표했습니다. 이번 시험은 불응성 급성 골수성 백혈병(AML) 및 고위험 골수형성이상증후군(MDS)과 같은 조건을 중심으로 7개 코호트에서 최대 14명의 환자를 평가할 것입니다.
GTB-3650은 카멜리드 나노바디 기술을 활용하여 2주 단위로(2주 투여 후 2주 중단) 최대 4개월 동안 투여됩니다. 이 연구는 안전성, 약물 동태학, 약물역학, NK 세포 증식 및 임상 활동을 평가하는 것을 목표로 합니다. 1상 시험의 초기 데이터는 2025년으로 예상됩니다.
GT Biopharma (NASDAQ: GTBP) a annoncé la dose de son premier patient dans un essai de phase 1 de GTB-3650, sa thérapie TriKE de deuxième génération, pour traiter les malignités hématologiques CD33 exprimant une récidive ou une réfractarité. L'essai évaluera jusqu'à 14 patients répartis en sept cohortes, en se concentrant sur des conditions telles que la leucémie myéloïde aiguë réfractaire (AML) et le syndrome myélodysplasique à haut risque (MDS).
GTB-3650, utilisant la technologie des nanobodies de camélidés, sera administré par blocs de deux semaines (deux semaines de traitement, deux semaines de repos) pendant une durée maximale de quatre mois. L'étude vise à évaluer la sécurité, la pharmacocinétique, la pharmacodynamique, l'expansion des cellules NK et l'activité clinique. Les premières données provenant de cet essai de phase 1 sont attendues en 2025.
GT Biopharma (NASDAQ: GTBP) hat die Verabreichung an sein erstes Patient in einer Phase-1-Studie von GTB-3650, seiner Zweitgeneration-TriKE-Therapie, zur Behandlung von rezidivierenden oder refraktären, CD33-exprimierenden hämatologischen Malignitäten angekündigt. Die Studie wird bis zu 14 Patienten in sieben Kohorten evaluieren, wobei der Fokus auf Erkrankungen wie refraktärer akuter myeloischer Leukämie (AML) und Hochrisiko-Myelodysplastischem Syndrom (MDS) liegen wird.
GTB-3650, das die Nanobody-Technologie von Kameliden nutzt, wird in zweiwöchigen Blöcken (zwei Wochen Behandlung, zwei Wochen Pause) über einen Zeitraum von bis zu vier Monaten verabreicht. Die Studie hat zum Ziel, Sicherheit, Pharmakokinetik, Pharmakodynamik, NK-Zellexpansion und klinische Aktivität zu bewerten. Erste Daten aus dieser Phase-1-Studie werden für 2025 erwartet.
- Successful initiation of Phase 1 trial with first patient dosed
- Proprietary camelid nanobody technology potentially offering improved potency and binding affinity
- Clear timeline with initial data expected in 2025
- Small trial size of only 14 patients indicates early-stage development
- Results not expected until 2025, indicating a lengthy development timeline
Insights
The initiation of GTB-3650's Phase 1 trial marks a significant advancement in GT Biopharma's immunotherapy pipeline. The use of camelid nanobody technology represents a important technological advantage - these single-domain antibodies are notably smaller than conventional antibodies, potentially enabling better tumor penetration and reduced immunogenicity. This could translate to improved clinical outcomes compared to existing CD33-targeted therapies.
The trial's design is particularly noteworthy: the two-week on/off dosing schedule suggests a strategy to optimize the balance between therapeutic efficacy and potential toxicity management. The focus on relapsed/refractory patients with AML and high-risk MDS addresses a significant unmet medical need - these conditions typically have poor prognoses with current standard treatments showing efficacy.
The inclusion of pharmacodynamic and NK cell expansion measurements as endpoints is strategically important. These biomarkers will provide early indicators of biological activity, potentially offering valuable insights into the therapy's mechanism of action before clinical responses become apparent. This could accelerate decision-making for future trial phases and help optimize patient selection criteria.
The market opportunity is substantial, considering that AML and MDS represent aggressive hematologic malignancies with treatment options. Success in this trial could position GT Biopharma favorably in the competitive landscape of NK cell-based therapies, particularly given the potential advantages of their proprietary TriKE platform.
- Initial data from the Phase 1 trial expected in 2025
SAN FRANCISCO, CALIFORNIA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
“We are thrilled to initiate patient dosing with GTB-3650 in the Phase 1 trial to evaluate the potential in patients with hematological malignancies, which represents a significant milestone for the company. As we continue to progress through clinical development, we eagerly anticipate sharing initial data from the study in 2025”, said Michael Breen, Executive Chairman and interim Chief Executive Officer of GT Biopharma.
GTB-3650 is GT Biopharma’s wholly owned second-generation TriKE. It utilizes camelid nanobody technology, with the potential to improve potency and enhance binding affinity. The Phase 1 dose escalation study will evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com.
Forward-Looking Statements
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TriKE® is a registered trademark owned by GT Biopharma, Inc.
Investor Relations Contact:
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