APVO436 receives Orphan Drug Designation for acute myeloid leukemia from the FDA

APVO436 has been granted Orphan Drug Designation (ODD) for the treatment of patients with acute myeloid leukemia (AML) by the United States Food and Drug Administration (FDA).¹ APVO436 is a bispecific antibody that is currently under investigation in patients with AML and myelodysplastic syndrome (MDS) in a phase I/Ib trial (NCT03647800).

APVO436 redirects T-cell cytotoxicity to tumor cells by targeting CD123 and CD3. APVO436 was developed using a proprietary platform, which can produce targeted bispecific antibodies with the ability to achieve potent biological activity and extended half-life. These antibodies can be used at lower concentrations than other bispecific antibody formats and can be built with a range of mechanisms of action.

ODD status means that a company is eligible to a seven-year exclusive marketing period and allows applications for funding for phase I and II clinical trials, with reduced market application filing fees and quicker regulatory processing.