Senti Biosciences Holdings Announces Positive FDA RMAT Meeting on Registrational Clinical and CMC Strategy for SENTI-202 in Relapsed/Refractory AML, Along with Important Efficacy and Durability Updates on the SENTI-202 Clinical Program
View original at globenewswire.comSenti Biosciences Holdings Announces Positive FDA RMAT Meeting on Registrational Clinical and CMC Strategy for SENTI-202 in Relapsed/Refractory AML, Along with Important Efficacy and Durability Updates on the SENTI-202 Clinical Program Following a Type B meeting with FDA, Senti Bio plans to proceed with a single-arm mu…
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Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X-derived SENTI-202 product; median survival was not reached for SENTI-202 NK4 group vs 56 days for vehicle
60% confidencePhase 1 patients receiving SENTI-202 from Donor X-derived NK cells achieved a 50% composite complete remission rate (7 out of 14 patients), compared to 12.5% (1 out of 8) for patients receiving non-Donor X SENTI-202
60% confidenceSENTI-202 continues to exhibit durable MRD-negative responses in the full 22-patient Phase 1 trial, which compares favorably with current FDA-approved therapies for R/R AML
60% confidenceSENTI-202's differentiated mechanism, off-the-shelf availability, and encouraging early clinical profile position the program as a potentially important next-generation treatment option for AML patients
60% confidenceSince filing of IND, Senti has focused on donor selection to minimize variability; identification of Donor X phenotype that correlates with increased activity continues to support SENTI-202's allogeneic manufacturing
60% confidenceThe Donor X attribute is found in approximately 50% of adult donors; published literature supports increased NK cell cytotoxicity in donors with this phenotype; Donor X NK phenotype is independent of HLA or KIR matching, supporting allogeneic off-the-shelf usage
60% confidenceThe positive FDA RMAT meeting marks a transformational moment for Senti Bio and significantly advances the path toward potential registration of SENTI-202; the Gene Circuit platform and Logic Gated cell therapies are validated by this milestone
60% confidenceAll CR/CRh responders who were in remission at the 2025 ASH annual meeting data-cut continue to maintain remission with an additional 7 months of follow-up, with the longest duration being 21+ months
60% confidenceFDA feedback provides clarity around registrational development strategy; MRD-negative durable complete remissions and favorable safety profile support confidence in transitioning to later-stage development; plans to explore expansion to newly diagnosed AML and pediatric AML
60% confidenceAt RP2D across all patients receiving a mix of Donor X and non-Donor X material, ORR was 44% and cCR was 37.5%, with 100% of complete remissions being MRD-negative
60% confidence