Senti Biosciences announced that enrollment in its first‑in‑human, logic‑gated CAR‑NK cell therapy SENTI‑202 has been completed for the relapsed or refractory acute myeloid leukemia (R/R AML) cohort, with 20 patients enrolled and 18 evaluable for response.
The interim data presented at the American Society of Hematology meeting in December 2025 show a 50 % overall response rate (ORR) and a 42 % complete remission (CR) rate, with all 8 CRs being measurable‑residual‑disease (MRD) negative. Hematologic adverse events were the most common, consistent with the underlying disease and lymphodepletion regimen, and no dose‑limiting toxicities or treatment‑related serious adverse events were reported.
Senti Biosciences has received both FDA orphan drug designation and regenerative medicine advanced therapy (RMAT) status for SENTI‑202, positioning the program for potential expedited review and highlighting the unmet need in R/R AML.
The company plans to engage with the FDA in the first half of 2026 to design a pivotal registration study and to explore expansion into newly diagnosed and pediatric AML indications, leveraging the data and safety profile established in the Phase 1 cohort.
Financially, Senti Biosciences remains a clinical‑stage company with no revenue and a negative earnings‑per‑share figure, but it holds approximately $21.6 million in cash and cash equivalents as of June 30, 2025, and has secured strategic collaborations with Spark Therapeutics, BlueRock Therapeutics, and Celest Therapeutics to support its pipeline.
Analysts continue to view the company favorably, citing the encouraging early‑stage data and the regulatory designations as key drivers of future growth, while noting the company’s limited cash runway and the inherent risks of early‑stage development.
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