Aptose gets CSRC approval to escalate TUS dose; CRs seen in difficult AML

Aptose Biosciences Inc.

CSRC unanimously approves dose escalation from 40 mg to 80 mg of tuspetinib in TUSCANY trial of TUS+VEN+AZA triplet.
Four patients dosed at 40 mg; no DLTs or prolonged myelosuppression; all remain on study.
Two FLT3-WT patients achieved CR/CRh; one patient with biallelic TP53 mutations and complex karyotype achieved CR.
Enrollment open for 80 mg cohort; 18-24 patients expected by mid-late 2025.
PK shows TUS plasma levels unaffected by AZA; VEN levels consistent with prior studies.

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