Why Is Gene Therapy Focused Senti Bio Stock Falling Today?

On Tuesday, Senti Biosciences, Inc. (NASDAQ:SNTI) shared new data from its ongoing trial of SENTI-202, a first-in-class CD33/FLT3 targeting Logic Gated CAR NK cell therapy in patients with relapsed or refractory Acute Myeloid Leukemia.

• Senti Biosciences shares are retreating from recent levels. What’s weighing on SNTI shares?

Data from 20 patients (18 with evaluable responses) were presented at the American Society of Hematology (ASH) Annual Meeting.

On Tuesday, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202.

Data Highlights:

50% (6/12) of patients at the Recommended Phase 2 Dose (RP2D) and 50% (9/18) of all trial patients achieved an Overall Response Rate (ORR) outcome.

42% (5/12) of patients at the RP2D and 39% (7/18) of all patients overall achieved a Complete Remission (CR) or CR with Partial Hematologic Recovery (CRh).

100% of all CRs and ~80%+ of all responses were minimal residue disease (MRD) negative.

With limited follow-up in the RP2D cohort, the Kaplan-Meier estimate of median duration of composite Complete Remissions across all patients is 7.6 months.

Longest durability of response greater than 1 year and continuing as of the data cut-off date.

Pharmacodynamic data validate SENTI-202’s OR/NOT Logic Gate mechanism of action for selectively killing AML blasts and leukemic stem cells (LSCs) while sparing healthy hematopoietic stem and progenitor cells (HSPCs).

SENTI-202 continues to be well-tolerated, with no dose-limiting toxicities, no SENTI-202-related serious adverse events, or adverse events resulting in discontinuation.

SENTI-202 was detected in the peripheral blood of all patients, with pharmacokinetics that were consistent with other allogeneic NK cell therapies: expansion in the peripheral blood for the first 2 weeks followed by natural clearance.

SENTI-202’s clinical responses show that the product has conferred meaningful clinical benefits to a heavily pretreated patient population.

SNTI Price Action: Senti Biosciences shares were down 16.73% at $1.99 at the time of publication on Tuesday, according to Benzinga Pro data.

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