Senti Biosciences, Inc. presented updated clinical data from the ongoing Phase 1 trial of SENTI-202 for relapsed or refractory Acute Myeloid Leukemia (AML) patients at ASH 2025.
The data showed high efficacy with a 50% Overall Response Rate (ORR) and 42% Complete Remission (CR/CRh) at the Recommended Phase 2 Dose (RP2D).
The pharmacodynamic data validated SENTI-202's unique mechanism of action for selectively targeting AML blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells.
High Efficacy
50% ORR and 42% CR/CRh demonstrated at RP2D, with majority of responses being MRD negative.
Novel Mechanism of Action
SENTI-202's OR/NOT Logic Gate selectively kills AML blasts and LSCs while sparing healthy HSPCs.
FDA RMAT Designation
FDA designation supports rapid advancement of SENTI-202 into pivotal studies for R/R AML and potential expansion into other indications.
- The data from SENTI-202's Phase 1 trial indicate promising results with deep and durable responses observed in a significant percentage of patients.
- The pharmacodynamic data further strengthen the potential of Senti's Logic Gates for precise and effective cell therapies in hematologic and solid cancers.
The clinical data presented by Senti Biosciences on SENTI-202 showcases its potential to be a significant advancement in treating relapsed or refractory AML patients, with high efficacy and a favorable safety profile.