Senti Bio's SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML

Core Insights - Senti Biosciences, Inc. presented positive preliminary data for SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory AML, at the AACR Annual Meeting 2025 [1][2][3] - The Phase 1 study identified a recommended Phase 2 dose (RP2D) of 1.5 x 10^9 CAR NK cells, with no dose limiting toxicities observed [3][4] - The therapy demonstrated a 71% overall response rate (ORR) among evaluable patients, with 4 out of 7 achieving composite complete remission (cCR) [3][5] Clinical Data - The study involved 9 patients treated with SENTI-202, with 7 evaluable for overall response [3] - Efficacy results included 5 of 7 patients achieving ORR, with 3 complete remissions (CR) and 1 CR with partial hematologic recovery (CRh) [3][9] - All cCR patients were found to be measurable residual disease (MRD) negative [3][9] Safety Profile - SENTI-202 was well-tolerated, with an adverse event profile consistent with other investigational NK cell therapies [9] - No grade 5 adverse events were reported, and most grade 3 or higher events were attributed to lymphodepleting chemotherapy rather than SENTI-202 [9] Financial Highlights - As of March 31, 2025, Senti Bio reported cash and cash equivalents of approximately $33.8 million [8] - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024 [15] - General and administrative expenses decreased to $7.1 million in Q1 2025 from $7.5 million in Q1 2024 [15] Pipeline Update - The Phase 1 study of SENTI-202 is ongoing, with plans for disease-specific expansion cohorts [4] - Senti Bio is also collaborating on SENTI-301A for hepatocellular carcinoma (HCC), although enrollment has been halted due to dose limiting toxicities observed in a related trial [10]