On Wednesday, H.C. Wainwright reaffirmed its Buy rating and $2.00 stock price target for shares of Aptose Biosciences (NASDAQ:APTO). This endorsement follows Aptose Biosciences' recent announcement of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to further the clinical development of tuspetinib (TUS).
The collaboration, announced on December 3, will explore the use of TUS in conjunction with targeted therapies for the treatment of molecularly defined acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The investigations will be part of the NCI Cancer Therapy Evaluation Program's myeloMATCH trials, which are specifically designed to accelerate the development of combination therapies for AML and MDS patients.
The analyst from H.C. Wainwright sees the collaboration as a strategic move, capitalizing on TUS's favorable safety profile and its demonstrated clinical activity.
Outside of the myeloMATCH program, Aptose is advancing a triplet combination regimen of TUS, venetoclax (VEN), and azacitidine (AZA) for newly diagnosed AML patients who are ineligible for chemotherapy. This is being done through the Phase 1/2 TUSCANY trial, which is set to commence dosing TUS at 40 mg, with plans to increase dosage pending positive safety assessments.
The TUSCANY trial protocol has been submitted to participating sites, reviewed by the FDA, and the study is expected to begin in the fourth quarter of 2024.
Additional milestones for Aptose Biosciences include presenting CR/safety data from the APTIVATE TUS+VEN doublet study and providing dosing accrual updates for the triplet study at the American Society of Hematology (ASH) meeting in the fourth quarter of 2024.
In the first half of 2025, Aptose aims to enroll two dose cohorts in the triplet study and report on complete remission, minimal residual disease, and safety data for the triplet study.
By 2025, the company plans to present maturing data for the triplet study at the European Hematology Association (EHA), finalize the TUS dose for the Phase 2/3 pivotal trials at ASH 2025, and prepare for Phase 2 of the Phase 2/3 pivotal program.
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