Senti Biosciences, Inc. (NASDAQ:SNTI) stock is skyrocketing on Monday, with a strong session volume of 73.4 million compared to an average volume of 17.81 thousand, as per data from Benzinga Pro.
The company reported initial clinical data from a Phase 1 trial of SENTI-202, a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, for relapsed/refractory hematologic malignancies including acute myeloid leukemia.
SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy bone marrow cells.
Three AML patients have been treated at the lowest dose level (1.0 billion CAR+ NK cells per dose) and, as of the data cutoff date of September 19, two achieved complete remission, confirmed by bone marrow biopsy, which includes blast reduction and recovery of blood cells to normal ranges.
In addition, both patients were assessed as measurable residual disease negative after treatment, defined as no detectable cancer cells in a bone marrow sample.
Both patients maintain remission (4+ months and 3+ months, respectively).
The Safety Review Committee cleared the lowest dose cohort, and dose escalation continues at the 1.5 billion CAR+ NK cells/dose level.
SENTI-202 was generally well-tolerated with no dose-limiting toxicities and an adverse event profile consistent with other investigational NK cell therapies and patients with underlying AML receiving lymphodepleting chemotherapy.
SENTI-202 transgene was detected in the peripheral circulation of all three patients and all cycles, with a pharmacokinetic profile generally consistent with other investigational CAR-NK therapy levels.
The company expects to enroll approximately 20 patients in the Phase 1 trial. A higher dose cohort of 1.5 billion CAR+ NK cells/dose is actively enrolling.
Additional safety and efficacy data, including initial durability data, are expected in 2025.
Concurrently, Senti Biosciences announced a private investment in public equity financing to issue and sell an aggregate of 16,713 shares of Series A Convertible Preferred Stock, with gross proceeds of approximately $37.6 million.
The company has also granted a certain investor an option to purchase an additional 4,444 shares of Preferred Stock and accompanying warrants for gross proceeds of approximately $10.0 million.
Senti Biosciences also announced that it has appointed Fran Schulz, an experienced biotechnology and financial executive, to the Senti Bio Board of Directors. Omid Farokhzad is departing from the Board in conjunction with Schulz’s appointment.
