Senti Biosciences (SNTI) Leerink Global Healthcare Conference 2026 summary

Technology overview and innovation

• Logic gating and gene circuits enable cell therapies to selectively kill cancer cells while sparing healthy cells, addressing the challenge of limited clean targets in oncology.

• Multi-specific targeting is achieved by combining activating CARs for cancer antigens and inhibitory CARs for healthy cell markers, validated in both NK and T cells.

• SENTI-202 targets AML using CD33 and FLT3 as activating targets and endomucin as an inhibitory target to protect healthy hematopoietic stem cells.

• The approach is generalizable across immune cell types and is being explored for both hematologic and solid tumors.

• Preclinical and clinical data demonstrate effective cancer cell elimination and protection of healthy cells.

Clinical development and trial results

• Phase I trial in relapsed/refractory AML showed a 42% CR/CRh rate at the recommended phase II dose, with 100% MRD negativity among CR patients and a median response durability of 7.6 months.

• Safety profile was favorable, with only mild infusion reactions and rapid hematopoietic recovery, attributed to the logic gate design and NK cell chassis.

• Correlative studies confirmed elimination of leukemic stem cells and preservation of healthy progenitors, supporting the mechanism of action.

• High proportion of patients were able to bridge to transplant, but durable responses were also observed in non-transplanted patients.

• Enrollment for phase I is complete with 22 patients, and results remain consistent with earlier data.

Regulatory and strategic outlook

• The program received RMAT designation, enabling enhanced FDA interaction and support for late-phase development.

• Plans are underway for a single-arm registrational trial, following regulatory precedent in AML, with patient numbers likely in the 100 range.

• The therapy is suitable for fitter AML patients able to tolerate low-dose chemotherapy, with ongoing evaluation of biomarker requirements.

• Manufacturing readiness for pivotal trials is established, and strong investigator interest is reported across major leukemia centers.

• Expansion into earlier lines, high-risk MDS, and solid tumors is being explored, with collaborations and new modalities under development.