secwatch.observer — SEC 8-K summary
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Issuer:     Senti Biosciences, Inc. (SNTI)
CIK:        0001854270
Form:       8-K
Filed at:   2025-12-09T23:59:59+00:00
Accession:  0001628280-25-055953
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1854270/000162828025055953/0001628280-25-055953-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1854270/000162828025055953/snti-20251209.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-055953

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