Senti Bio Wins CIRM Grant for CAR-NK Cell Therapy Development

Senti Biosciences, Inc. (Nasdaq: SNTI), a biotechnology firm specializing in advanced cell and gene therapies through its proprietary Gene Circuit platform, has been awarded an $8 million grant by the California Institute for Regenerative Medicines (CIRM). This grant is intended to support the ongoing clinical development of SENTI-202, an innovative off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy targeting relapsed or refractory hematologic malignancies, particularly acute myeloid leukemia (AML).

SENTI-202 is currently undergoing a Phase 1 clinical trial, with early efficacy data expected by the end of 2024 and initial durability data anticipated in 2025. The trial is enrolling adult patients in the United States and Australia who have relapsed or refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML. The study is evaluating two dose levels of SENTI-202 cells, either 1 billion or 1.5 billion cells, administered in cycles of three weekly doses following disease-specific lymphodepleting conditioning. Patients may continue to receive multiple treatment cycles based on safety and efficacy outcomes.

SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, sparing healthy bone marrow cells. The therapy comprises three main components: the OR GATE, an activating CAR targeting CD33 and FLT3; the NOT GATE, which protects healthy cells from being killed; and calibrated-release IL-15 technology, which enhances cell persistence, expansion, and activity of both CAR-NK cells and host immune cells. The NK cells used in SENTI-202 are derived from healthy adult donors and cryopreserved to ensure uniformity and quality.

Timothy Lu, M.D., Ph.D., CEO and Co-Founder of Senti Bio, expressed gratitude to CIRM for their support and acknowledged the progress made in the clinical development of SENTI-202. He emphasized the company's commitment to providing potentially lifesaving treatments for cancer patients.

Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults, affecting blood and bone marrow. In the United States, approximately 20,800 new cases are expected in 2024, with a five-year survival rate of about 30%. Current treatments include chemotherapy, targeted therapies, and stem cell transplants, but options are limited for patients with relapsed or refractory AML, who typically have a median overall survival of less than seven months.

Senti Bio is focused on developing next-generation cell and gene therapies for patients with incurable diseases, leveraging its Gene Circuits platform to create therapies with enhanced precision and control. The company's pipeline includes off-the-shelf CAR-NK cells equipped with Gene Circuits, targeting both liquid and solid tumors. Senti Bio has also demonstrated the potential of Gene Circuits in other disease areas through partnerships with Spark Therapeutics and BlueRock Therapeutics.

CIRM, created to accelerate stem cell treatments for patients with unmet medical needs, partners with academia and industry to advance promising stem cell technologies. With $5.5 billion in funding and over 150 active stem cell programs, CIRM is one of the world's largest institutions dedicated to advancing cellular medicine.

By securing this grant, Senti Bio aims to make significant strides in the clinical development of SENTI-202, potentially offering a new treatment option for patients with challenging hematologic malignancies.