Affected person enrollment for Senti Biosciences’ SENTI-202 section I trial has been accomplished
Senti Biosciences has accomplished affected person recruitment in its Part I medical trial evaluating SENTI-202 in adults with relapsed or refractory acute myeloid leukemia (r/r AML).
The corporate is growing SENTI-202 as a cluster of differentiation 33/fms-like tyrosine kinase 3 (CD33/FLT3)-targeted Logic Gated chimeric antigen receptor pure killer (CAR NK) cell remedy.
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Senti Biosciences just lately offered knowledge on the American Society of Hematology (ASH) annual assembly displaying that SENTI-202 led to deep, MRD-negative, sturdy full remissions and a positive security profile in closely pretreated r/r AML sufferers.
Upon completion of enrollment, Senti Biosciences plans to have interaction with the U.S. Meals and Drug Administration (FDA) within the first half of 2026 on progress towards a pivotal regulatory program, together with potential research in newly identified and pediatric AML.
SENTI-202 has been granted Regenerative Drugs Superior Remedy (RMAT) designation, which might speed up the event and overview course of.
The product accommodates an OR GATE to kill goal cells, a NOT GATE to spare wholesome cells, and IL-15 with calibrated launch to enhance cell persistence.
The FDA has granted Orphan Drug Designation (ODD) and RMAT standing to SENTI-202 for the remedy of relapsed or refractory hematologic malignancies, together with AML.
Senti Biosciences Chief Medical Officer Kanya Rajangam stated: “The completion of enrollment in our Part I examine represents an vital medical milestone for our SENTI-202 program.
“Importantly, the encouraging medical knowledge from this examine present a powerful basis as we actively design our pivotal program for SENTI-202 in AML, in addition to potential indication growth and later-stage medical growth.
“We look ahead to productive discussions and shut collaboration with the FDA within the first half of this yr to debate the subsequent section of growth for our RMAT-designated program.”
In January 2024, Senti Biosciences minimize 37% of its workforce because it reallocated assets to advance the medical growth of SENTI-202.
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