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Shattuck Labs Announces Orphan Drug Designation Granted by the U.S. Food and Drug Administration (FDA) for SL-172154 for the Treatment of Acute Myeloid Leukemia (AML)
AUSTIN, TX and DURHAM, NC, June 10, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering
About this update from Shattuck Labs, Inc.
[{"type":"text","content":" AUSTIN, TX and DURHAM, NC, June 10, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced that the U.S. FDA has granted orphan drug designation (ODD) to lead clinical candidate SL-172154 for the treatment of AML. “AML patients have few options for treatment and a poor prognosis. FDA’s decision to grant orphan drug designation to SL-172154 highlights the urgent need for new treatment options,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “This is an important first step in our progression to later-stage clinical studies, and we look forward to presenting additional data from the Phase 1B dose expansion clinical trial of SL-172154 with azacitidine in frontline higher-risk myelodysplastic syndromes and TP53m AML patients during a poster presentation at the European Hematology Association 2024 Congress.” The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, and waiver of application fees. About AML AML is a hematologic malignancy that develops from clonal expansion of myeloid precursors residing in the bone marrow. In patients with AML, leukemic blasts infiltrate the bone marrow and disrupt normal hematopoiesis. According to the National Cancer Institutes’ Surveillance, Epidemiology, and End Results Program, in 2023, there were approximately 20,380 new cases of AML in the U.S., with 11,310 deaths attributed to the disease. The median age of diagnosis is 68 years with approximately one-third of patients being diagnosed over the age of 75. More than 70% of patients 65 years or older will die from their disease within one year of diagnosis. As of 2019, the five-year relative survival rate for acute myeloid leukemia was approximately 32%. About SL-172154SL-1721...