In This Article:
Senti Biosciences, Inc. SNTI announced positive initial data from a phase I study that evaluated its chimeric antigen receptor natural killer (CAR-NK) cell therapy candidate, SENTI-202, for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML).
Shares of the company skyrocketed 363% on Dec. 2 following the announcement of the news.
Per management, a potential first-in-class off-the-shelf CAR-NK cell therapy, SENTI-202, has been developed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies, like AML, while not affecting the healthy bone marrow cells.
SNTI stock has surged 51.5% so far this year against the industry’s decline of 7.1%.
Image Source: Zacks Investment Research
More on the Initial Data from SNTI's Phase I Study
Initial data from the phase I study showed that two out of the three AML patients who were treated at the lowest dose level (1.0 billion CAR+ NK cells per dose) achieved complete remission (“CR”), confirmed by bone marrow biopsy as of the data cutoff date of Sept. 19, 2024.
Additionally, both patients achieved measurable residual disease (“MRD”) negative following treatment with SENTI-202.
Per the press release, MRD negative indicates that no detectable cancer cells are present in a bone marrow sample as checked by the most sensitive locally available method.
While one patient maintains remission of four-plus months, the other maintains remission of three-plus months as of today.
Treatment with SENTI-202 was generally well-tolerated in all three AML patients.
More Updates on SNTI's SENTI-202 & Other Pipeline
Last December, the FDA cleared SNTI’s investigational new drug (IND) application to begin clinical studies on SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including AML.
Following the FDA’s clearance of the IND, Senti Bio initiated a phase I study on SENTI-202 at various sites in the United States and Australia.
Senti Bio expects to enroll around 20 patients in the phase I study on SENTI-202. A higher dose cohort (1.5 billion CAR+ NK cells/dose) is currently enrolling patients.
Additional safety and efficacy data, including durability data, is expected in 2025.
Senti Bio has another cancer candidate in its portfolio, SENTI-301A.
In November 2023, Senti Bio entered into a collaboration agreement with China-based biotechnology company, Celest Therapeutics, for the clinical development of SENTI-301A to treat solid tumors in China.
Celest Therapeutics leads the clinical development of SENTI-301A and plans to dose the first patient in a pilot study in mainland China later in 2024.