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.