Gracell Biotechnologies has thrown down a gauntlet to Novartis and Gilead Sciences with a CD19-targeting CAR-T for B-cell acute lymphoblastic leukaemia (B-ALL) that can be produced in a single day.
The Chinese biotech’s FasT CAR-19 has been tested in a clinical trial in patients with relapsed or refractory B-ALL, with 23 of 24 patients achieving a complete remission after treatment with the cell therapy, and 21 having undetectable minimal residual disease after 28 days.
Those results suggest that FasT CAR19 – also known as GC007F) – could be a match clinically for already-marketed CD19 CAR-Ts from Novartis (Kymriah) and Gilead (Yescarta), but Gracell thinks its therapy has another key advantage.
The CAR-T samples for each of the 26 patients enrolled into its trial were manufactured overnight with a 100% success rate, while it takes on average two weeks to manufacture rival CD19-targeting CAR-Ts, plus seven days to clear quality testing, from the time cells are harvested from the patient.
The testing phase still applies with Gracell’s approach of course, but that means the CAR-T therapy can be prepared in as little as eight days, whereas Kymriah needs a 3-4 week production process and Gilead suggests Yescarta takes 26-29 days to prepare.
The biotech thinks that its express approach to production will also reduce the cost of therapy compared to the approved CAR-Ts, as well as offering improved efficacy because the modified T cells that are given back to the patient are “younger and less exhausted”.
Yescarta and Kymriah have US list prices of $373,000 and $475,000 per procedure, respectively, and haven’t yet gathered much momentum in the market.
Kymriah is approved for B-ALL as well as diffuse large B-cell lymphoma (DLBCL) – a form of non-Hodgkin’s lymphoma – and made just over $100m in sales in the first six months of this year, pegged back by production problems. Meanwhile, Gilead reported $216m in first-half sales from DLBCL and another NHL variant called primary mediastinal large B-cell lymphoma (PMBCL).
Gracell is also preparing Fast CAR therapies for NHL and other haematological cancers such as multiple myeloma (MM).
GC007F is already in testing for NHL while it is also developing two FasT CARs that target a pair of antigens that it hopes will improve efficacy and reduce the risk of relapse – another challenge with CAR-T therapies.
GC012 is targeting BCMA and another undisclosed antigen in MM, while GC022 is aiming at CD19 and CD22 and is in development for NHL.