On June 15, 2021 Senti Biosciences, Inc., a leading gene circuit company, reported that it has signed a lease agreement for a property in Alameda, California for the build-out of its wholly-owned cell therapy manufacturing facility (Press release, Senti Biosciences, JUN 15, 2021, View Source [SID1234584384]). Senti Bio is designing the 92,000 square-foot facility to meet current Good Manufacturing Practices (cGMP) with the goal of providing clinical and commercial-scale manufacturing for multiple allogeneic, or "off-the-shelf", chimeric antigen receptor (CAR) natural killer (NK) cell product candidates.
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The facility is being designed to support planned initial clinical trials for Senti Bio’s product candidates, SENTI-202 for acute myeloid leukemia (AML) and SENTI-301 for hepatocellular carcinoma (HCC), which are both preclinical-stage allogeneic CAR-NK cell candidates engineered with gene circuit technologies. Internal manufacturing capabilities are central to Senti Bio’s business strategy of maintaining control over the quality and supply of its present and future candidates for allogeneic CAR-NK cell therapies. The Alameda site was selected to be strategically located near the Company’s headquarters and R&D center in South San Francisco, California.
"We believe that the application of next-generation allogeneic CAR-NK cell therapies has the potential to improve the lives of cancer patients who currently face limited treatment options. Furthermore, if our clinical programs are successful, we believe this facility could support the manufacturing of multiple future product candidates at both clinical and commercial scale," said Philip Lee, PhD, Chief Technology Officer and co-founder of Senti Bio. "Within this facility, we envision bringing together the latest technologies and exceptional manufacturing talent. We look forward to pursuing our goal of creating allogeneic cell therapies that can be manufactured from healthy donor cells in advance of clinical use, and then stored in frozen vials to be delivered rapidly to patients in an off-the-shelf manner."
This manufacturing facility is being designed as a customized end-to-end manufacturing solution to give Senti Bio the ability to isolate NK cells, engineer these cells with proprietary gene circuits, perform cell culture expansion in large batches, and cryopreserve and store the final cGMP products.
About SENTI-202 and SENTI-301
SENTI-202 and SENTI-301 are preclinical product candidates being developed for the potential treatment of AML and HCC, respectively. SENTI-202 is a Logic Gated (OR + NOT) allogeneic CAR-NK cell therapy candidate that is being designed to target and eliminate AML cells while sparing healthy bone marrow cells. SENTI-301 is a Multi-Armed allogeneic CAR-NK cell therapy candidate that is being designed to overcome disease evasion for the treatment of HCC.