Aptose Signs CRADA with NCI to Develop Tuspetinib for AML and MDS in Newly Launched MyeloMATCH Precision Medicine Trials
03 Dezembro 2024 - 9:30AM
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
PietropaoloCorporate Communications & Investor
Relations201-923-2049spietropaolo@aptose.com
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