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U.S. FDA grants Orphan Drug Designation to SL-172154
On June 10, 2024, the U.S. Food and Drug Administration granted Orphan Drug Designation to SL-172154 for the treatment of patients with acute myeloid leukemia (AML). SL-172154 (SIRPα-Fc-CD40L), an Agonist Redirected Checkpoint (ARC®) fusion protein, inhibits the CD47/SIRPα checkpoint interaction while simultaneously activating the CD40 costimulatory receptor to enhance an anti-tumor immune response.1
SL-172154 is currently being investigated in an open-label, multicenter, phase Ia/Ib clinical trial (NCT05275439; SL03-Old Hundred[OHD]-104) in patients with AML and high-risk myelodysplastic syndromes. This trial will evaluate safety, pharmacodynamics, and pharmacokinetics of SL-172154 monotherapy and in combination with azacitidine or azacitidine and venetoclax.1,2
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