Prelim data reveal encouraging results…
Gracell Biotechnologies Ltd. announced complete remission induced in B-cells for all cancer patients participating in a single-dose study of FasT CAR-19 therapy, preliminary data show.
According to the company’s website, Gracell is “a clinical-stage biopharmaceutical company dedicated to discovering and developing best in class cellular therapeutics for patients suffering from hematological malignancy, solid tumors or degenerative disease.”
Their recent announcement is based on a FasT CAR-19 experimental cell therapy treatment that induced complete remission in B-cell acute lymphoblastic leukemia patients during a Phase 1 trial.
The company reports that all patients were previously administered various lines of therapy pre-trial, and 87% were found to achieve minimal residual negativity (low levels of leukemia cells in bone marrow). Initial findings were presented at the CAR-TCR Summit Asia in Shanghai June 18–20, 2019.
In an April press release, Dr. William Wei Cao — Gracell’s founder, chairman, and CEO — said that in the past, “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.”
US FDA & China FDA Approved
Gracell Bio has a manufacturing facility in Shanghai, China that’s in accordance with both U.S. FDA and China FDA standards.
Their facilities and scientists are focused on medical biotechnologies that include a gene-editing platform that targets antibody engineering, expression technology, and gene editing.
The company’s current projects include: Next-Generation CAR-T Technologies (Parallel CAR-T, Split CAR-T, Switchable CAR-T), Strategies to Overcome Tumor Micro-Environment (TME), and Novel Co-Stimulatory Factors (the factors that impact various functional, metabolic, and safety profiles on CAR-T cells)
Gracell’s FasT CAR-19 trial is still recruiting patients from 2–70 years old. Learn more information about the study here
