Allogene builds allogeneic CAR-T site, looking ahead to ‘commercial product’

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Jojje9999)
(Image: Getty/Jojje9999)

Related tags: Allogene, Pfizer, Cellectis, Allogeneic CAR-T, CAR-T

Allogene enters a lease agreement to develop a 118,000-square-foot site for the manufacture of allogeneic CAR-T therapies.

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).

Pipeline

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​.

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