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Shattuck Labs Receives FDA Orphan Drug Status for SL-172154 Targeting Acute Myeloid Leukemia (AML)

Tuesday, June 11, 2024

Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology firm developing innovative bifunctional fusion proteins for cancer and autoimmune treatments, has announced that the FDA has awarded orphan drug status to SL-172154 for acute myeloid leukemia (AML).

Shattuck, commented, "There is a pressing need for new therapies for AML patients given the limited treatment options available. The FDA’s designation of SL-172154 as an orphan drug is a crucial step as we advance towards further clinical trials. We look forward to presenting more data from the Phase 1B dose expansion trial, investigating SL-172154 in combination with azacitidine for frontline higher-risk myelodysplastic syndromes and TP53 mutant AML patients, at the upcoming European Hematology Association 2024 Congress."

The FDA's Office of Orphan Products Development grants orphan status to treatments for diseases affecting fewer than 200,000 individuals in the U.S. This designation provides drug developers with various benefits, such as potential market exclusivity for seven years post-approval, eligibility for tax credits on qualifying clinical studies, and fee waivers for drug application submissions.

AML is a type of cancer originating from the uncontrolled growth of myeloid precursors in the bone marrow, disrupting normal blood cell production. According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there were about 20,380 new AML cases in the U.S. in 2023, with 11,310 associated deaths. The median age at diagnosis is 68, and approximately one-third of patients are diagnosed after the age of 75. More than 70% of patients aged 65 and older succumb to the disease within a year of diagnosis, and the five-year relative survival rate for AML as of 2019 is around 32%.

SL-172154 (SIRPα-Fc-CD40L) is a potential ARC® fusion protein that targets the CD47/SIRPα checkpoint and activates the CD40 receptor to strengthen the anti-tumor immune response in patients with advanced cancers. Phase 1 clinical trials are currently ongoing for patients with platinum-resistant ovarian cancer (NCT04406623, NCT05483933) and those with AML and high-risk myelodysplastic syndromes (NCT05275439).



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