Senti Biosciences Inc SNTI received FDA clearance for its Investigational New Drug (IND) application for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies while sparing healthy bone marrow cells.
The company plans to initiate a Phase 1 clinical trial of SENTI-202 in 2024 in multiple sites in the U.S. and Australia and expects to treat the first patient in the second quarter of 2024.
The dose-finding trial will evaluate two dose levels, either 1 or 1.5 billion SENTI-202 cells, administered after lymphodepleting conditioning in adult patients with relapsed or refractory (r/r) CD33 and/or FLT3 expressing hematologic malignancies, including acute myeloid leukemia (AML).
Initial dosing will consist of three doses administered weekly following lymphodepletion, with the option to receive continuation cycles of lymphodepletion and SENTI-202 cells based on safety and efficacy data.
The company expects to disclose initial efficacy data from the Phase 1 trial by year-end 2024 and durability data in 2025. Through Senti Bio's previously announced agreement with GeneFab, the company has prepaid the majority of manufacturing-related expenses through the completion of the Phase 1 trial.
Price Action: SNTI shares are up 30.7% at $0.58 on the last check Friday.
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