Senti Biosciences (NASDAQ:SNTI) soared 29% on Tuesday after unveiling encouraging clinical data from its SENTI-202 cancer therapy program and securing Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.
The biotech firm shared interim findings from its ongoing study of SENTI-202, an engineered CAR-NK cell therapy designed for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML). At the Phase 2 recommended dose, the treatment produced a 50% overall response rate and a 42% complete remission rate, with complete remissions lasting a median of 7.6 months across all participants. The data were presented at the American Society of Hematology Annual Meeting.
SENTI-202 is built using Senti Bio’s proprietary “OR/NOT Logic Gate” framework, a synthetic biology mechanism that allows the therapy to target malignant cells selectively while preserving healthy tissue. The patient group studied was particularly challenging, with 65% carrying adverse genetic risk factors and a median history of two prior therapies.
The FDA’s RMAT designation highlights the promising potential of SENTI-202 in addressing unmet needs in R/R AML. It is the second major regulatory recognition for the program this year, following the Orphan Drug Designation granted in June.
Dr. Nosha Farhadfar emphasized the significance of the results, stating, “SENTI-202 continues to demonstrate deep, durable responses and a favorable safety profile in patients with relapsed or refractory AML, where standard therapies often offer patients a survival rate of just a few months.”
Safety outcomes were a key positive in the update, with no dose-limiting toxicities or treatment-related serious adverse events observed—an encouraging sign for potential outpatient administration.
With momentum building, Senti Bio intends to push SENTI-202 rapidly into pivotal clinical studies and evaluate the therapy’s potential for additional populations, including newly diagnosed AML, pediatric cases, and related hematologic disorders such as myelodysplastic syndromes.