Allogene builds allogeneic CAR-T site, looking ahead to ‘commercial product’
The San Francisco, US, based company is aiming to take on a portion of its manufacturing responsibility by building a site to provide clinical trial supply, and potentially the commercial supply of AlloCAR T product.
Allogene Therapeutics anticipates the facility will be completed by March 2020, at which point the lease will officially begin. The company has signed a 15-year lease, with the option to extend by 10 years, dependent upon certain conditions.
Under the terms of the lease agreement, Allogene will pay $159,150 (€140,071) per month, with a 3% increase each year.
Currently, the company uses a contract manufacturing organisation (CMO) for the manufacture of its clinical trial supply, which will remain a part of its long-term manufacturing plans, according to a statement.
Allogeneic CAR-T manufacture
Allogene’s activity in the chimeric antigen receptor (CAR)-T space will be watched closely, after it was founded by David Chang and Arie Belldegrun, former CMO and CEO of Kite, respectively.
Being able to produce CAR-T therapies through donated T cells, rather than through the process currently employed of using the patient’s own cells, could simplify the manufacturing process and prove more convenient for patients.
Current methods of manufacturing consistent, on-spec autologous CAR-T treatments has proven difficult, leading Novartis to divert investment away from traditional production to focus on its process for Kymriah (tisagenlecleucel).
Allogene acquired its pipeline of allogeneic products from Pfizer, which included 16 preclinical assets and lead candidate, UCART19. As a part of the deal, Pfizer holds a 25% stake in Allogene.
Cellectis is also eligible to receive clinical and commercial milestone payments, after Pfizer used its platform to build its CAR-T portfolio, including UCART19.
However, Allogene is not the only company in the race to bring an allogeneic CAR-T treatment through to market.
Celyad recently became the first company to have its application for investigational new drug designation for its non-gene edited allogeneic CAR-T accepted. Janssen is also working in the space, through its partnership with Transposagen.