Research Triangle Park Facility to Manufacture Precision’s Pipeline of Off-the-Shelf CAR T Product Candidates to Support Clinical Trials
Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its proprietary ARCUS® genome editing platform, announced today the opening of its Manufacturing Center for Advanced Therapeutics (MCAT), the first in-house current Good Manufacturing Process (cGMP) compliant manufacturing facility in the United States dedicated to genome-edited, off-the-shelf chimeric antigen receptor (CAR) T cell therapy products. This is part of a larger investment by the company in its cancer immunotherapy platform and facilities expansions in North Carolina in 2019. This new facility expands Precision BioSciences’ footprint, adding to a thriving North Carolina life sciences industry and providing opportunities for new high-skill jobs with a focus on manufacturing.
“As part of our mission to overcome cancer and provide valuable new treatment options for patients, we are rapidly advancing a pipeline of next-generation, off-the-shelf CAR T product candidates and we anticipate, once optimized, this platform will be able to support two new clinical programs per year,” said Matt Kane, Chief Executive Officer and co-founder of Precision BioSciences. “Given the potential output of our platform, we’ve known from the beginning that it was critical for us to address the need for scalable manufacturing of cell-therapy products in order to be able to effectively deliver them to patients. In addition to our clinical work, it also has the potential to be a commercial launch facility with the capacity to generate up to 10,000 doses of CAR T cell therapies and 4,000 doses of gene therapies per year.”
Currently, the new facility is undergoing CQV (commissioning, qualification, and validation) in preparation for cGMP manufacturing to begin in the fourth quarter of 2019. It is a multi-product facility designed to produce three different drug substances: allogeneic CAR T cells, messenger RNA (including formulations development) and adeno-associated viral vectors. Precision intends to initially use this new manufacturing center to create clinical trial material for its Phase I/II clinical trials in 2020. Precision BioSciences’ MCAT facility is designed to meet regulatory requirements in the United States, Europe and Japan.
About Precision BioSciences
Precision BioSciences is dedicated to improving life (DTIL) through its proprietary genome editing platform, “ARCUS.” Precision BioSciences leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. For more information regarding Precision BioSciences, please visit www.
