Senti Bio Granted U.S. FDA Orphan Drug Designation for Use of First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, SENTI-202 to Treat Acute Myeloid Leukemia

Core Insights - Senti Biosciences, Inc. announced progress in the Phase 1 clinical trial of SENTI-202 for treating Acute Myeloid Leukemia (AML), with the FDA granting Orphan Drug Designation for the therapy [1][2] - The company aims to address the significant unmet need in relapsed/refractory AML, which has a median survival rate of only 5.3 months [2] - SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy cells [2] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company’s pipeline includes cell therapies engineered with Gene Circuits targeting challenging liquid and solid tumor indications [4] - Senti Bio's Gene Circuits have shown preclinical efficacy in both NK and T cells, with potential applications beyond oncology [4] Regulatory Milestone - The FDA's Orphan Drug Designation provides Senti Bio with various benefits, including tax credits and exemptions from certain FDA fees, as well as potential market exclusivity for seven years post-approval [3]