On April 23, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell"), an immune cell gene therapy company, reported it has developed FasT CAR-T, a revolutionary platform that shortens the manufacturing time of CAR-T treatments from two weeks to one day (Press release, Gracell Biotechnologies, APR 23, 2019, View Source [SID1234539456]). FasT CAR-T also lowers manufacturing costs to a fraction of previous CAR-T therapies, while showing higher potency of CD19-directed FasT CAR-T ("CD19-F-CAR-T") in B-Cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin Lymphoma (NHL), both in vitro and in vivo.
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With a first-in-human clinical study of CD19-F-CAR-T ongoing, Gracell said early clinical results show the therapy is safe and significantly more potent (20-40 times) than conventionally manufactured CAR-T agents (C-CAR-T) for treating B-ALL. Gracell released the data of CD19-F-CAR-T during a presentation at the Global CAR-T Cell Therapy Development Shanghai Forum, held April 16-17, 2019.
FasT CAR-T requires only one day for manufacturing (plus 7 days for releasing tests per regulatory requirement), while C-CAR-T manufacturing takes about two weeks plus 7 days for testing. Hence, FasT CAR-T reduces vein-to-vein time by an average of 12 days, which is critical for patients with rapidly progressing disease. More importantly, CD19-F-CAR-T has demonstrated superior expansion capability, with a younger and less exhausted phenotype, according to the Company.
Dr. William Wei Cao, founder, chairman and CEO of Gracell, said, "Lengthy manufacture, high cost, relapse, and ineffectiveness in solid tumors of CAR-T products are the major challenges the CAR-T industry is facing. Gracell’s mission is to develop highly effective but low cost CAR-T cancer therapies for large unmet needs. Without support from patients, their families, and clinical scientists, we wouldn’t be able to advance the very promising FasT CAR-T technology."
Gracell has been developing a series of highly effective and low-cost CAR-T products, including Dual-CAR-T, Off-the-shelf CAR-T, and Enhanced-CAR-T products for treating solid tumors, two of which will be entering IND filing by the end of this year. Next year, the company plans to file INDs for three additional products.
Led by Dr. Cao, who previously served as co-founder and CEO of a Nasdaq-listed cell therapy company, Gracell was founded in 2017. Up to today, the company has raised nearly US$100 million combined, with Series B financing led by Temasek, joined by Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji, and Series A led by 6 Dimensions.