Senti Bio reports SENTI-202 Phase 1 data: 50% ORR, 42% CR/CRh at RP2D; receives FDA RMAT designation

Senti Biosciences, Inc.

In 18 evaluable R/R AML patients, SENTI-202 achieved 50% ORR and 42% CR/CRh at RP2D; 100% of CRs MRD negative and median duration of CR 7.6 months.
SENTI-202 was well-tolerated with no DLTs, no drug-related SAEs, and most AEs hematologic consistent with lymphodepletion.
FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for SENTI-202, adding to prior Orphan Drug Designation.
Logic Gate mechanism validated: selective killing of AML blasts/LSCs while sparing healthy hematopoietic stem/progenitor cells.
Company to host investor call Dec 9 at 8 AM ET; SENTI-202 potential for pivotal studies and expansion into newly diagnosed AML, pediatric AML, MDS.

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