Aptose Biosciences has secured a loan of $10m through a facility agreement with Hanmi Pharmaceutical to advance the development of tuspetinib, a treatment for acute myeloid leukaemia (AML).
Tuspetinib is an oral kinase inhibitor with potential as both a monotherapy and in combination therapies for newly diagnosed and relapsed or refractory AML patients.
The funds will be directed towards the development of tuspetinib, particularly assessing it as a frontline triplet therapy for newly diagnosed AML patients.
The loan may be converted as prepayment for milestone obligations under a future collaboration agreement or repaid following the anticipated completion of a triple-drug combination study with tuspetinib.
Aptose and Hanmi signed an exclusive global licence agreement in November 2021 for the development and commercialisation of the product, which was originally discovered by the latter.
From January 2022, Aptose has been managing the ongoing study and clinical programme for tuspetinib.
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The collaboration between Aptose and Hanmi extends beyond the current facility agreement.
The two companies are in discussions to negotiate a new co-development collaboration agreement for tuspetinib, which is expected to provide additional funding to expedite its clinical development.
Tuspetinib is analysed in a worldwide Phase I/II open-label dose-escalation clinical study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics in relapsed or refractory AML patients.
Aptose concluded the Phase I/II dosage escalation and dose exploration of tuspetinib and is presently enrolling patients in the expansion programme.
The company has found a safe therapeutic range with a broad therapeutic window encompassing dosage levels of 40, 80, 120 and 160mg, and has chosen 120mg as the initial single-agent expansion dose and 80mg as the initial dose for combination with venetoclax.
Aptose develops precision medicines to meet the unmet medical needs in oncology, focusing initially on haematology.
