Allogene Therapeutics Enters Lease to Build Manufacturing Facility to Develop and Commercialize Allogeneic CAR T (AlloCAR T™) Therapies
- State-of-the-Art Manufacturing Facility to be Located in the San Francisco East Bay Area
- Allogene Committed to Advanced Cell Manufacturing for Long-Term Clinical and Commercial AlloCAR T™ Production
"Building state-of-the-art manufacturing capabilities is at the core of our strategy to deliver readily available cell therapy faster, more reliably and at greater scale,” said
The new manufacturing facility is being designed to provide 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 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 (GvHD) and allogeneic rejection. Engineered AlloCAR T™ cells undergo expansion and are ultimately cryopreserved for on demand delivery to patients.
The facility is part of the Gateway 84 Silicon Valley advanced manufacturing campus currently under construction. Allogene was represented by
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. The Allogene portfolio includes rights to 16 pre-clinical 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 1 in the first half of 2019 for the treatment of relapsed/refractory non-Hodgkin lymphoma (
Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to complete the build-out of the manufacturing facility, the ability to manufacture AlloCAR T™ therapies, the timing and ability to initiate and progress clinical trials and obtain regulatory approval for any AlloCAR T™ therapy, the ability to initiate and progress additional clinical trials of AlloCAR T™ therapies, and the potential benefits of AlloCAR T™ therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
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Source: Allogene Therapeutics, Inc.