Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.

Inclusion Criteria:

• Patients who have progressed on standard therapy or have no established alternativetreatment, with a diagnosis of:

• R/R AML (WHO 2022) OR

• MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;

• Adequate baseline organ function.

Exclusion Criteria:

• Having been treated with any CD123-targeting therapies;

• Having received allogeneic hematopoietic stem cell transplantation within 100 daysprior to start Cycle 1 Day 1;

• Having treatment-related toxicities from prior anti-leukemia therapies that have notresolved to CTCAE Grade ≤ 1;

• Having active central nervous system AML or AML of the APL/M3 subtype;

• History of keratitis;

• History of specified lung or renal disease;

• Having clinically significant cardiovascular disease;

• Known infection of Hepatitis B, C or E.

Key inclusion and exclusion criteria details are listed here, additional requirements may apply.