FasTCAR is our Next-day Manufacturing autologous CAR-T platform that tackles the most pressing challenges associated with autologous therapies, including lengthy manufacturing time, suboptimal manufacturing quality, high therapy cost, and poor T cell fitness. In November 2022, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards.
Advantages of FasTCAR
FasTCAR vs Conventional CAR-T Manufacturing Process
In the conventional CAR-T manufacturing process, a patient’s T cells are first activated using CD3 and/or CD28 antibodies, and then transduced by virus vectors to express one or more CARs. These engineered CAR-T cells are then expanded ex vivo before they are administered back into the human body. This process typically takes one to six weeks.
Using our proprietary FasTCAR platform, we are able to concurrently activate and transduce resting T cells into a single “concurrent activation-transduction” step using XLenti vectors derived from lentivirus that are of high quality and exhibit high gene transduction efficiency. As a result, after transduction, one or more CARs are integrated in the T cell genome and expressed stably. Based on our preclinical studies, these transduced T cells are highly active in proliferation and tumor cell clearance, and therefore can be administered into the human body without the need for ex vivo cell expansion. With these innovations, our FasTCAR technology transforms the activation, transduction and expansion steps into a single “concurrent activation-transduction” step, as depicted in the figure below, significantly reducing the autologous CAR-T cell manufacturing time from an industry norm of one to six weeks and achieving next-day manufacturing.
We believe that our FasTCAR technology can be applied broadly to any CAR-T antigens and a variety of tumor markers, based on our clinical and preclinical studies. We are currently developing several autologous product candidates targeting hematologic malignancies, including RRMM, NDMM, B-NHL, SLE and AML.
Fully-Closed Production Lines
Our Suzhou manufacturing facility established fully-closed production capabilities, designed to produce FasTCAR product candidates while reducing contamination risks and optimizing cost-efficiency. We believe these advantages, coupled with our ability to achieve next-day manufacturing for autologous CAR-T cells, allow us to substantially reduce manufacturing cost, improve productivity and scale up our production in a cost-efficient manner. We have the capacity to support our preclinical, clinical development and early commercialization with our GMP facility in China. We have also expanded our manufacturing capabilities to the United States to enable a local supply of high-quality novel cell therapies, including through collaborations with contract development and manufacturing organizations in the U.S.