Senti Bio Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for SENTI-202 in the Treatment of Adults with Relapsed or Refractory Acute Myeloid Leukemia

Core Insights - The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory hematologic malignancies, including AML [1][2][7] - This designation highlights the urgent need for improved treatments for relapsed/refractory AML and the potential of SENTI-202 to significantly impact the treatment landscape for this aggressive cancer [2][3] Company Overview - Senti Biosciences is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][10] - The company aims to engineer therapies that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [10] Product Development - SENTI-202 is currently in a Phase 1 clinical trial targeting adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML [2][8] - The therapy utilizes a Logic Gated approach, featuring an OR GATE for activating CAR that targets CD33 and/or FLT3, and a NOT GATE to protect healthy cells [8] - Clinical data presented at the ASH Annual Meeting indicated a 50% Overall Response Rate (ORR) and a 42% Complete Remission (CR) rate at the Recommended Phase 2 Dose (RP2D), with a median duration of composite Complete Remission of 7.6 months [7][8] Regulatory Milestones - The RMAT designation is the second FDA recognition for SENTI-202 in 2025, following the Orphan Drug Designation received in June [2][9] - RMAT designation facilitates closer collaboration with the FDA, providing guidance on data generation to support product approval [4][7] Clinical Progress - Recent presentations at the ASH Annual Meeting showcased updated clinical data, reinforcing SENTI-202's efficacy, safety, and durability in treating relapsed/refractory AML [2][3] - The company is actively enrolling patients for the ongoing Phase 1 trial, which could lead to a first-in-class allogeneic treatment option for AML/MDS patients [8]