Gracell Bio has launched its new CAR-T production platform, and the China-based biotech claims its technology can reduce the manufacturing time for the cell therapy from two weeks to just one day.
The company’s ‘FasT CAR-T’ only requires eight days to complete the production process, which is made up of the one day of manufacturing plus seven days for releasing tests, it claims.
This is compared to the standard CAR-T procedure, which on average takes around three weeks.
The timing of that method is due to its highly sophisticated process, which includes supercharging a patient’s own immune cells outside the body to identify and fight cancer cells after they are placed back inside the body.
This complexity has also led to some drugmakers struggle with production issues, such as Novartis and its first-to-market CAR-T Kymriah.
“FasT CAR-T reduces vein-to-vein time by an average of 12 days, which is critical for patients with rapidly progressing disease”, according to Gracell, and says this also lowers its manufacturing cost to a fraction of existing therapies.
This improvement in manufacturing techniques is seen as vital for the long-term viability of CAR-T products, which currently don’t represent a profitable business model for the industry.
There are currently two CAR-T therapies on the US market, Kite/Gilead’s Yescarta, which comes in at a list price of $373,000 per patient for Non-Hodkin Lymphoma (NHL), and already mentioned Novartis’ Kymriah, which costs $475,000 per patient.
Gracell confirmed that the tech is not only compatible with the CAR-Ts that are already marketed, but it improves effectiveness of the CAR-Ts in both ALL and NHL.
William Wei Cao (below), founder, chairman and CEO of Gracell, said: “Lengthy manufacture, high cost, relapse, and ineffectiveness in solid tumours 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.”
The company was founded in 2017, and after raising nearly $100m in financing it has focused on developing low-cost CAR-T products, including enhanced CAR-T products for treating solid tumours, two of which is due for an IND filing by the end of this year.
In other CAR-T news, the University of Southern California says it has discovered a new method to modify already existing CAR-Ts to reduce their toxicity profile without hindering efficacy.
Severe cytokine release syndrome can lead to life-threatening multi-organ damage and brain swelling. In the revised version, researchers tweaked the sequence and shape of the CAR molecules. As a result, the CAR-T cells kill cancer cells but produce fewer cytokines and proliferate more slowly, giving the patient’s body more time to clear cytokines in the blood.
The lab modified Novartis’ Kymriah and tested the cell therapy in 25 patients, but further development work will be needed to validate any new approaches to building CAR-Ts.