-Gracell conquers effective, low cost, and high speed manufacturing of cellular 
gene therapeutics

Gracell Biotechnologies, Co., Ltd. ("Gracell"), an immune cell gene therapy 
company, announced it has developed FasT CAR-T, a revolutionary platform that 
shortens the manufacturing time of CAR-T treatments from two weeks to one day. 
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. 

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. 

About Gracell

Established in 2017, Gracell Biotechnologies Co., Ltd. ("Gracell") is 
headquartered in Suzhou, China, with additional locations in Shanghai and Hong 
Kong. Gracell is dedicated to resolving the cellular gene therapy industry's 
major challenges including high production costs, lengthy manufacturing 
process, lack of off-the-shelf products, and short duration of therapeutic 
effects. Gracell's mission is to bring best-in-class and affordable cellular 
medicines to cancer patients. 

SOURCE  Gracell Biotechnologies, Co., Ltd.