Senti completes enrolment in SENTI-202 Phase I trial in relapsed or refractory AML
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
Senti Biosciences has completed enrolment of patients in its Phase I clinical trial assessing SENTI-202 in adults with relapsed or refractory acute myeloid leukaemia. The company recently presented data showing that SENTI-202 led to deep, MRD-negative, durable complete remissions and a favourable safety profile in heavily pretreated r/r AML patients. Following completion of enrolment, the company plans to engage with the U.S. Food and Drug Administration in the first half of 2026 about progressing to a pivotal registration programme.
The company is developing SENTI-202 for the treatment of acute myeloid leukemia and myelodysplastic syndrome, and as a cluster of differentiation 33/fms-like tyrosine kinase 3 targeting Logic Gated chimeric antigen receptor natural killer cell therapy. The product incorporates an OR GATE to kill target cells, a NOT GATE to spare healthy cells, and calibrated-release IL-15 to enhance cell persistence.
The drug previously received orphan drug and regenerative medicine advanced therapy designation from the U.S. Food and Drug Administration for treating relapsed or refractory haematologic malignancies, including AML. Following a Type B Initial Comprehensive Multidisciplinary RMAT meeting, the company stated that it had completed the chemistry, manufacturing, and controls requirements to advance the pivotal Phase 1 single-arm, multi-center trial in refractory or relapsed AML with SENTI-202 administered after LD chemotherapy.
The company said it plans to discuss potential studies in newly diagnosed and paediatric AML as part of the next phase of development. In January 2024, the company cut 37% of its workforce as it reallocated funds to advance the clinical development of SENTI-202.
For the first quarter of 2026, net losses amounted to $4.22 million, or $0.14 per share, compared with $14.11 million, or $1.41 per share, in the same period in the prior year. Research and development expenses were $5.3 million, compared with $3.9 million in the previous year, and cash, cash equivalents, and marketable securities on March 31, 2026, amounted to $8.93 million. The company entered a security purchase agreement with an affiliate of Celadon Partners SPV 24, which may result in gross proceeds of $40 million aggregate in senior secured convertible notes, and the company is also eligible to receive up to $60 million in milestone payments during the development of SENTI-202.