Senti Biosciences, Inc. (SNTI), Tuesday presented new data from its ongoing multinational Phase 1 trial evaluating SENTI-202 for treating patients with relapsed or refractory Acute Myeloid Leukemia or AML at ASH 2025.
AML is one of the most aggressive blood cancers, with limited treatment options and poor survival rates in relapsed patients.The open-label study enrolled 20 patients, of whom 18 were evaluable for response. SENTI-202, a first-in-class CD33/FLT3- targeting Logic Gated CAR-NK cell therapy, was administered following fludarabine/ cytarabine lymphodepletion.
The trial demonstrated a 50% overall response rate or ORR across all patients, with 42% achieving complete remission or CR. Notably, 100% of CRs and 83% of all responses were MRD-negative, underscoring the therapy's potential to deliver deep and durable remissions. The median duration of composite CR was 7.6 months, with some responses lasting beyond one year.
SENTI-202 was well tolerated, with no dose-limiting toxicities or treatment-related serious adverse events, the company noted. Most adverse events were hematologic and consistent with the underlying disease and lymphodepletion regimen. The most frequent SENTI-202-related adverse events were Grade 1/2 pyrexia, likely infusion-related and resolving quickly with standard care. This favorable safety profile supports the potential for outpatient administration.
Mechanistic data validated SENTI-202's novel OR/NOT Logic Gate design.
SENTI-202 also showed expansion in peripheral blood during the first two weeks, followed by natural clearance, consistent with other allogeneic NK therapies.
The U.S. FDA recently granted SENTI-202 Regenerative Medicine Advanced Therapy or RMAT designation, following earlier Orphan Drug Designation, highlighting its potential to address a serious unmet medical need.
Senti Bio plans to advance SENTI-202 into pivotal studies and explore expansion into broader patient populations, including newly diagnosed AML, pediatric AML, and myelodysplastic syndromes.
SNTI is currently trading in the pre-market at $2.89, up 21.33%. Over the past 12 months, the stock has traded between $1.26 and $6.48.
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