Senti Biosciences Announces FDA IND Clearance for SENTI-202, a Logic-Gated Allogeneic CAR-NK Therapy for CD33/FLT3-Positive Hematologic Malignancies

Recently, Senti Biosciences announced that the U.S. FDA has approved the IND application for its investigational CAR-NK cell therapy, SENTI-202, for the treatment of hematologic malignancies expressing CD33 and/or FLT3.

SENTI-202 is a logic-gated CAR-NK designed to selectively target and eliminate hematologic malignancies expressing CD33 and/or FLT3, such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), while protecting healthy cells.

SENTI-202 consists of three main components:OR GATE：Targeting CD33AndFLT3-activating CAR, recognizing tumor cells;NOT GATE: By recognizing healthy cells through protective antigens,Designed to protectHealthy cells are not attacked;IL-15 Precision ReleaseTechnology:Enhance the Persistence of Therapeutic Cells, expansion and activity, as well as enhanced immune cell function in the patient's tumor environment.

SENTI-202 is also an "off-the-shelf" cell therapy, with cells sourced from qualified healthy donors. Senti Biosciences screens donors in advance according to standards and cryopreserves the cells before production to minimize variability and enhance manufacturability and product quality.

Senti Biosciences, Inc. expects the first patient in the Phase 1 clinical trial of SENTI-202 to receive treatment in the second quarter of 2024.To be disclosed by the end of 2024Phase 1 ClinicalThe preliminary efficacy data will be disclosed, and the durability data will be released in 2025.

It is worth noting that the SENTI-202 trial formulation will be provided byGeneFab is responsible for manufacturing. GeneFab was established in 2023, built on the foundation of acquiring the CMC service business from Senti Biosciences, Inc. The CEO of GeneFab is Dr. Philip Lee, the former Chief Technology Officer of Senti Biosciences, Inc.

Senti Biosciences, Inc. was founded in 2016 by a leading figure in synthetic biology.James J. Collins and Timothy Lu (卢冠达)Co-founded by others.

In 2021,Senti Biosciences, Inc.Going public through a merger with a special purpose acquisition company (SPAC) Dynamics Special Purpose Corp.

Senti Biosciences uses synthetic biology to design gene circuits. Gene circuit technology can program cell DNA, integrating multiple target information with biological logic to more efficiently and precisely target diseased cells while protecting healthy cells.

Senti’s proprietary platform includes specific gene circuit technologies, such as logic gates, small molecule regulators, combination payloads, and synthetic promoters, which have the potential to confer higher efficacy, precision, and control to cell and gene therapy products. By mixing and matching different gene circuits together, it may be possible to create a new generation of enhanced-function drugs.

Senti Bio's main candidate products include SENTI-202,AllogeneicGPC3-TargetedCAR-NK CellsSENTI-301A，CEA CAR-NK CellsSENTI-401, etc. SENTI-202 is the company's first logic-gated CAR-NK cell candidate to advance to clinical trials.

Despite the backing of synthetic biology heavyweights like Timothy Lu, Senti Biosciences is still facing challenges of funding shortages in the capital winter.

Since Senti Biosciences, Inc. was listed on NASDAQ, its stock price fluctuated between 1-2 US dollars in 2022. As of last Friday, the closing price was 0.52 US dollars after a continuous decline in 2023.

Due to a shortage of funds,SentiPublicSenti Biosciences announced the suspension of the development of SENTI-301A at the beginning of 2023 and is seeking partners for co-development.

In addition, Senti Biosciences, Inc. sold its CMC process to Celadon Partners in August 2023 to establish GeneFab, and subleased its cGMP facility located in Alameda, California, to GeneFab; the transaction amount was380$0 million, but still need to deduct the $18.9 million in prepaid future manufacturing and support service fees from Senti Bio to GeneFab – a loss-making deal.

This series of operations has provided Senti Bio with sufficient cash flow to support the company's operations until the fourth quarter of 2024.

However, good news is coming.

November 2023，Senti BioSenti Biosciences, Inc.Celest TherapeuticsSENTI-301AAchieveCooperation,Senti BioQualifiedMilestones and royalties of up to $156 million。

December 2023,Senti Bio's first candidate drug advances to clinical stage, with stock price rising 18.45% to $0.52 per share.

With the funding brought by project collaborations and the positive news of product clinical progress, Senti Bio may be on a steady rise.