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Gracell Bio Announces Fast, Cost-Effective CAR-T Manufacturing Technology

publication date: Apr 23, 2019
author/source: Richard Daverman, PhD

Gracell Biotechnologies, a Suzhou immune cell gene therapy company, announced a new technology, FasT CAR-T, 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, said Gracell, while showing higher potency of CD19-directed FasT CAR-T in B-Cell acute lymphoblastic leukemia (B-ALL) (20-40 times) and non-Hodgkin Lymphoma (NHL), both in vitro and in vivo.

A first-in-human clinical study of CD19-F-CAR-T is underway. Gracell said early clinical results show the therapy is safe and significantly more potent than conventionally manufactured CAR-T agents 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.

According to Gracell, 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. That means FasT CAR-T reduces vein-to-vein time by an average of 12 days, which is critical for patients with rapidly progressing disease. In addition, 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 CAR-T products,, which it expects will combine highly efficacy with low-cost. These include Dual-CAR-T, Off-the-shelf CAR-T, and Enhanced-CAR-T products that will treat solid tumors. Two of these 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. So far, the company has raised a total of nearly $100 million, consisting of a Series B financing led by Temasek (joined by Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji) and a Series A led by 6 Dimensions.

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.

See our other articles on Gracell.

Disclosure: ChinaBio® has a business relationship with Gracell.


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