FasTCAR is our 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 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 two 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 two to six weeks and achieving next-day manufacturing (22 to 36 hours).
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 MM, B-ALL and B-NHL, as well as earlier-stage product candidates targeting a variety of indications, such as ovarian cancer and breast cancer.
We established fully-closed production capabilities in our Suzhou and Shanghai facilities, which are designed to produce autologous FasTCAR product candidates while reducing contamination risks and optimizing cost-efficiency. With this fully-closed design, we are able to operate multiple systems in one manufacturing cleanroom at the same time, with each system producing CAR-T cells for an individual patient. This compares to autologous CAR-T cell therapy manufacturers without a fully-closed system that can only produce one batch of CAR-T cells for a single patient in one manufacturing cleanroom at one time in order to avoid potential cross-contamination. Our fully-closed system reduces reagent consumable costs, labor costs, workshop equipment operations and depreciation.
We believe these advantages, coupled with our ability to achieve next-day manufacturing for autologous CAR-T cells in one production shift, allow us to substantially reduce manufacturing cost, improve productivity, and scale up our production in a cost-efficient manner. We currently manufacture our lead product candidates GC019F and GC007F on these fully-closed lines.