Aptose Signs CRADA with NCI to Develop Tuspetinib for AML and MDS in Newly Launched MyeloMATCH Precision Medicine Trials
Aptose Biosciences (NASDAQ: APTO, TSX: APS) has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop tuspetinib for AML and MDS treatment. The collaboration will focus on testing tuspetinib in targeted drug combinations through the NCI's myeloMATCH precision medicine trials, which launched on May 16, 2024. The trials aim to develop tailored drug combinations for newly diagnosed AML and MDS patients.
Separately, Aptose is developing tuspetinib as part of a triple drug combination (tuspetinib, venetoclax, and azacitidine) in newly diagnosed AML patients unfit for chemotherapy, with the Phase 1/2 TUSCANY study set to begin in Q4.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) ha stipulato un Accordo di Ricerca e Sviluppo Cooperativa (CRADA) con il National Cancer Institute (NCI) per sviluppare tuspetinib per il trattamento del AML e dell'MDS. La collaborazione si concentrerà sul testare tuspetinib in combinazioni di farmaci mirati attraverso gli studi di medicina di precisione myeloMATCH del NCI, lanciati il 16 maggio 2024. Questi studi mirano a sviluppare combinazioni di farmaci personalizzate per pazienti con AML e MDS appena diagnosticati.
Separatamente, Aptose sta sviluppando tuspetinib come parte di una combinazione tripla di farmaci (tuspetinib, venetoclax e azacitidina) per pazienti con AML appena diagnosticati non idonei alla chemioterapia, con lo studio Fase 1/2 TUSCANY che dovrebbe iniziare nel quarto trimestre.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) ha firmado un Acuerdo de Investigación y Desarrollo Cooperativo (CRADA) con el Instituto Nacional del Cáncer (NCI) para desarrollar tuspetinib para el tratamiento de AML y MDS. La colaboración se centrará en probar tuspetinib en combinaciones de medicamentos dirigidos a través de los ensayos de medicina de precisión myeloMATCH del NCI, que se lanzaron el 16 de mayo de 2024. Los ensayos tienen como objetivo desarrollar combinaciones de medicamentos personalizadas para pacientes recién diagnosticados con AML y MDS.
Por separado, Aptose está desarrollando tuspetinib como parte de una combinación triple de medicamentos (tuspetinib, venetoclax y azacitidina) para pacientes recién diagnosticados con AML que no son aptos para quimioterapia, con el estudio de Fase 1/2 TUSCANY programado para comenzar en el cuarto trimestre.
Aptose Biosciences (NASDAQ: APTO, TSX: APS)는 tuspetinib을 AML 및 MDS 치료를 위해 개발하기 위해 국립암연구소(NCI)와 협력 연구 및 개발 계약(CRADA)을 체결했습니다. 이번 협력은 2024년 5월 16일 시작된 NCI의 맞춤형 의학 시험 myeloMATCH를 통해 목표 약물 조합에서 tuspetinib의 시험에 중점을 두게 됩니다. 이 시험은 새로 진단된 AML 및 MDS 환자를 위한 맞춤형 약물 조합 개발을 목표로 하고 있습니다.
별도로, Aptose는 화학요법에 불모한 새로 진단된 AML 환자를 위한 약물의 삼중 조합(tuspetinib, venetoclax, azacitidine)의 일환으로 tuspetinib을 개발하고 있으며, 1/2상 TUSCANY 연구가 4분기에 시작될 예정입니다.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) a conclu un Accord de Recherche et Développement Coopératif (CRADA) avec le National Cancer Institute (NCI) pour développer tuspetinib pour le traitement de l'AML et du MDS. La collaboration se concentrera sur le test de tuspetinib dans des combinaisons de médicaments ciblés à travers les essais de médecine de précision myeloMATCH du NCI, qui ont été lancés le 16 mai 2024. Ces essais visent à développer des combinaisons de médicaments sur mesure pour les patients récemment diagnostiqués avec de l'AML et du MDS.
Séparément, Aptose développe tuspetinib dans le cadre d'une combinaison de trois médicaments (tuspetinib, venetoclax et azacitidine) pour les patients récemment diagnostiqués avec de l'AML qui ne sont pas aptes à la chimiothérapie, l'étude de phase 1/2 TUSCANY devant commencer au quatrième trimestre.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) hat eine Kooperationsvereinbarung über Forschung und Entwicklung (CRADA) mit dem National Cancer Institute (NCI) unterzeichnet, um tuspetinib zur Behandlung von AML und MDS zu entwickeln. Die Zusammenarbeit wird sich darauf konzentrieren, tuspetinib in gezielten Medikamentenkombinationen im Rahmen der myeloMATCH-Präzisionsmedizin-Studien des NCI zu testen, die am 16. Mai 2024 gestartet wurden. Die Studien zielen darauf ab, maßgeschneiderte Medikamentenkombinationen für neu diagnostizierte AML- und MDS-Patienten zu entwickeln.
Separat entwickelt Aptose tuspetinib als Teil einer dreifachen Medikamentenkombination (tuspetinib, venetoclax und azacitidin) für neu diagnostizierte AML-Patienten, die nicht für eine Chemotherapie geeignet sind, und die Phase 1/2-Studie TUSCANY soll im vierten Quartal beginnen.
- Selection of tuspetinib for prestigious NCI-sponsored clinical trials program
- Collaboration with National Cancer Institute through CRADA agreement
- Expansion into frontline therapy for newly diagnosed patients
- Development of triple drug combination therapy advancing to clinical trials
- None.
Insights
The NCI's selection of tuspetinib for the myeloMATCH trials represents a significant validation of the drug's potential in treating AML and MDS. The CRADA agreement enables testing of novel drug combinations in frontline settings, expanding beyond the current relapsed/refractory focus. This could accelerate the path to market and broaden the drug's commercial potential.
The parallel development of the TUS+VEN+AZA triplet combination shows strategic positioning, as venetoclax combinations are currently the standard of care in AML. The planned 40 mg starting dose is well-supported by existing safety data, while the ability to escalate doses provides flexibility to optimize efficacy. The FDA-reviewed TUSCANY trial initiation in Q4 indicates strong regulatory engagement and execution.
For a micro-cap company with
The dual-track development strategy - participating in myeloMATCH while advancing the TUSCANY trial - maximizes the probability of success and potential market opportunities. A successful outcome in either program could drive substantial value creation, considering the multi-billion dollar AML/MDS market. However, investors should note that clinical development remains high-risk given the company's financial resources.
- Tuspetinib selected for a prestigious national clinical research program for ability to target broad spectrum of AML and MDS populations
- Trials to test tuspetinib in targeted drug combinations for frontline therapy of molecularly defined sub-groups of newly diagnosed AML and MDS
SAN DIEGO and TORONTO, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced that the National Cancer Institute (NCI), part of the National Institutes of Health, and Aptose Biosciences Inc. have entered into a Cooperative Research and Development Agreement (“CRADA”). Under the CRADA, the NCI and Aptose will collaborate on the clinical development of Aptose’s proprietary lead clinical-stage compound tuspetinib (TUS), an inhibitor of key signaling kinases involved in myeloid malignancies, in the NCI Cancer Therapy Evaluation Program (CTEP) sponsored myeloMATCH trials employing combinations of targeted therapy for the treatment of molecularly defined acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) populations. These trials will be conducted by NCI's National Clinical Trials Network (NCTN), with the participation of the NCI Community Oncology Research Program (NCORP) in the U.S. and Canada.
The myeloMATCH precision medicine trials (NCT05564390), funded by the NCI, were officially launched on May 16, 2024. myeloMATCH aims to expedite the development of tailored drug combination treatments for patients with newly diagnosed AML and MDS and to treat patients with these aggressive cancers of the blood and bone marrow from diagnosis throughout their treatment journey.
“We’re grateful to be a part of NCI’s myeloMATCH precision medicine trials,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. “The executed CRADA will facilitate our collaboration with NCI on clinical studies of novel-novel combinations with early phase II signal finding endpoints in AML and MDS. Tuspetinib will provide the NCI and AML/MDS patients with an investigational agent that can be used to treat a broad spectrum of AML/MDS populations, including those among the most genetically challenging.”
“We are indeed privileged to have tuspetinib selected to be part of this one-of-a-kind initiative, which recognizes that significant breakthroughs and higher response rates for AML and MDS may be possible with triplet combination therapies,” said Rafael Bejar, M.D., Ph.D., Aptose’s Chief Medical Officer. “We expect that tuseptinib’s safety profile and breadth of activity will make it an ideal combination agent and we are pleased to have NCI’s support in its clinical development.”
In addition, Aptose is separately developing tuspetinib as a key component of a triple drug combination (tuspetinib, venetoclax, and azacitidine; TUS+VEN+AZA) in newly diagnosed AML patients unfit for chemotherapy, with plans to begin dosing at the 40 mg dose of tuspetinib that was previously shown active as a single agent in relapsed or refractory AML patients. The dose of tuspetinib then can be further escalated after safety review. The protocol for the Phase 1/2 TUSCANY study of TUS+VEN+AZA in newly diagnosed AML has been submitted to sites and reviewed by the U.S, Food and Drug Administration (FDA). The study is on track to commence during the fourth quarter.
About Tuspetinib
Tuspetinib (TUS) is being developed as a TUS + venetoclax (VEN) + hypomethylating agent (HMA) triple drug combination (or TUS+VEN+HMA triplet) as frontline therapy for newly diagnosed AML patients. Aptose’s APTIVATE Phase 1/2 trial illustrated the safety and breadth of activity of TUS monotherapy and the TUS+VEN doublet combination in relapsed or refractory (R/R) AML patients and supports the launch of the TUS+VEN+HMA (using azacitidine, AZA, as the HMA) triplet frontline therapy in newly diagnosed AML patients. Tuspetinib, a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. In the APTIVATE trial, TUS achieved broad activity across AML patients with a diversity of adverse genetics as a single agent and in combination with venetoclax in a very ill and heavily pre-treated AML population. Blast reductions and objective responses were observed in patients with prior-VEN, prior-FLT3 inhibitor (FLT3i) and prior-HSCT therapies, those with highly adverse genetics - including mutations in TP53 and RAS genes, and those with mutated or unmutated (wildtype) FLT3 genes.
About Aptose
Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company’s lead clinical-stage compound tuspetinib (TUS) is an oral kinase inhibitor that has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit www.aptose.com.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the therapeutic potential and safety profile of tuspetinib and its clinical development, the aim of myeloMATCH, the timing of the Phase 1/2 study of TUS+VEN+AZA and the initial dosing of tuspetinib, as well as statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations and to continue as a going concern; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
For further information, please contact:
Aptose Biosciences Inc.
Susan Pietropaolo
Corporate Communications & Investor Relations
201-923-2049
spietropaolo@aptose.com
FAQ
What is the purpose of Aptose's (APTO) CRADA agreement with NCI?
When did the myeloMATCH precision medicine trials for APTO's tuspetinib begin?
What is the triple drug combination Aptose (APTO) is developing with tuspetinib?
When is APTO's Phase 1/2 TUSCANY study expected to begin?
