Gracell Biotechnologies Unveils Revolutionary FasT CAR-T Platform, Cutting Manufacturing Time from Two Weeks to One Day

Artery New Medicine (WeChat ID: biobeat1) has learned that on April 23, 2019, Gracell Biotechnologies Inc. (“Gracell”), a company dedicated to the research and development of immune cell gene therapies, announced the development of its revolutionary FasT CAR-T manufacturing platform.

This technology reduces CAR-T manufacturing time from two weeks to one day, and compared with previous conventional CAR-T therapy (C-CAR-T), FasT CAR-T significantly lowers manufacturing costs. Meanwhile, in vivo and in vitro studies have shown that CD19-directed FasT CAR-T ("CD19-F-CAR-T") exhibits higher efficacy against both B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma (NHL).

Gracell is currently conducting the first-in-human clinical study of FasT CAR-T. The company stated that preliminary results indicate this therapy is safe and significantly more effective than conventional CAR-T (C-CAR-T) products, with the effective dose for treating B-cell acute lymphoblastic leukemia (B-ALL) being only 1/20 to 1/40 of that required for C-CAR-T. Gracell presented the outstanding results from the first-in-human study of FasT CAR-T at the Global CAR-T Cell Therapy Development Forum held in Shanghai on April 16–17, 2019.

FasT CAR-T requires only one day of manufacturing time (although, to meet regulatory requirements, quality release testing takes seven days), whereas C-CAR-T production generally takes approximately two weeks, plus an additional seven days for testing. Consequently, FasT CAR-T can be infused back into patients approximately 12 days earlier. This is critical for patients with rapidly progressing disease. More importantly, Gracell has stated that CD19-F-CAR-T exhibits a phenotype characterized by a higher proportion of less-exhausted, more youthful cells and demonstrates robust expansion capacity.

Dr. Cao Wei, Founder, Chairman, and CEO of Gracell, stated, “The major challenges facing the CAR-T industry include lengthy manufacturing timelines, high costs, susceptibility to relapse, and inefficacy against solid tumors. Gracell’s mission is to provide highly effective, low-cost immune cell gene therapies to a broad population of cancer patients. Without the support of patients, their families, and clinical scientists, we would not have been able to develop our promising FasT CAR-T technology into a therapeutic product.”

Gracell has successfully completed the development of a series of highly efficient, low-cost CAR-T products. In addition to its FasT CAR-T platform, the company has completed preclinical development of dual chimeric antigen receptor (CAR) T-cell products, off-the-shelf CAR-T products, and enhanced CAR-T products for the treatment of refractory solid tumors. Two of these products are scheduled to submit Investigational New Drug (IND) applications by the end of this year, with three additional products planned for IND submission next year.

Gracell, founded in 2017 and led by Dr. Cao Wei, was established by a founder who previously served as Co-Founder and CEO of a NASDAQ-listed cell therapy company. Since its inception, the company has raised nearly $100 million in financing, including a Series B round led by Temasek with participation from Lilly Asia Ventures, Kington Capital, King Star Capital, and Chengdu Miaoji, as well as a Series A round invested by Tonghe Yucheng.

Gracell Bio, founded in 2017 and headquartered in Suzhou, China, maintains R&D centers and offices in Shanghai and Hong Kong. Gracell Bio is dedicated to addressing the major challenges facing the cell and gene therapy industry, including high production costs, lengthy manufacturing processes, a lack of off-the-shelf products, and short-lived therapeutic efficacy. The company’s mission is to provide cancer patients with the best possible, affordable cell and gene therapies.

Source: Gracell Biotechnologies