Allogene Therapeutics, a clinical-stage biotechnology company developing allogeneic chimeric antigen receptor T cell (CAR T) therapies for cancer, and headquartered in South San Francisco, California, has entered into a lease agreement to build a 118,000-square-foot cell-therapy manufacturing facility in Newark, California. The facility will be used to manufacture the company’s proprietary allogeneic CAR T therapies, AlloCAR T.

The new manufacturing facility is being designed to provide good manufacturing practices (GMP) manufacturing for clinical supply and commercial product upon potential regulatory approval. Allogene currently manufactures its clinical trial supply through a contract manufacturing organization, which continues to remain a component of the company’s long-term manufacturing strategy. The facility is part of the Gateway 84 Silicon Valley advanced manufacturing campus currently under construction.

The company’s AlloCAR T cell therapies are engineered from cells of healthy donors, which is intended to allow for creation of inventory for on-demand use in patients. This approach is designed to eliminate the need to create personalized therapy from a patient’s own cells, simplify manufacturing, and reduce the time patients must wait for CAR T cell treatment, according to the company.

The manufacturing of AlloCAR T therapy begins with harvesting T cells from healthy donors. Donor T cells are engineered to express chimeric antigen receptors (CARs), which are designed to recognize certain cell-surface proteins expressed on hematologic or solid tumors. Genes within T cells are then edited to reduce the risk of graft versus host disease and allogeneic rejection. Engineered AlloCAR T cells undergo expansion and are ultimately cryopreserved for on-demand delivery to patients, according to information from the company.

Allogene is developing a pipeline of “off-the-shelf” CAR T cell-therapy candidates. The Allogene portfolio includes rights to 16 preclinical CAR T cell therapy assets and AlloCAR T therapy candidates ALLO-501 and UCART19.

Allogene is the sponsor of the ALLO-501 program, which is expected to begin Phase I in the first half of 2019 for the treatment of relapsed/refractory non-Hodgkin lymphoma (NHL). Servier is the sponsor of the UCART19 program which is currently in Phase I for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL).

Source: Allogene Therapeutics