The Gates Biomanufacturing Facility (GBF) today announced a continued strategic agreement with Nkarta, Inc. to manufacture clinical supply of therapeutic Natural Killer (NK) cells. As part of this collaboration, GBF will continue to manufacture NKX101, Nkarta’s clinical stage investigational NK cell therapy, in its facility on the University of Colorado Anschutz Medical Campus in Aurora, Colorado.
NKX101 is an “off-the-shelf” investigational immunotherapy currently in a Phase 1 clinical trial for patients with relapsed/refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS). To produce NKX101, NK cells obtained from the peripheral blood of healthy donors are engineered with membrane-bound interleukin 15 and a chimeric antigen receptor (CAR) to enhance the targeting and killing of tumor cells. The engineered NK cells are then expanded at scale to generate an abundant supply of doses. NKX101 is not approved by regulatory authorities, and its safety and efficacy have not been established.
The Gates Biomanufacturing Facility on the CU Anschutz Medical Campus is one of the few Good Manufacturing Practice (GMP) facilities located on a major academic research and clinical campus with the capacity to manufacture both cell and protein-based therapies for academic researchers as well as biotechnology companies.
“Our partnership with the Gates Biomanufacturing Facility is an excellent fit,” said Ralph Brandenberger, PhD, Senior Vice President, Technical Operations. “GBF’s strong execution, along with their commitment to both quality and speed, enabled us to advance the development of NKX101 and dose patients in our Phase 1 clinical trial. We look forward to continuing our important collaboration.”
“Collaborating with a publicly-traded company with the reputation and caliber of Nkarta marks an important milestone for GBF,” said Gates Biomanufacturing Facility Executive Director Matthew Seefeldt. “Their continued partnership with our facility is a testament to the outstanding team in place here and our commitment to maintaining the highest standards for GMP manufacturing cell-therapies for Phase I trials. We are thrilled to collaborate with Nkarta and to be part of their effort to bring these promising therapies to patients.”
About the Gates Biomanufacturing Facility
The Charles C. Gates Center for Regenerative Medicine, in partnership with the University of Colorado School of Medicine, UCHealth University of Colorado Hospital, Children's Hospital Colorado, the Gates Frontiers Fund and the private sector have established a state-of-the-art Phase I GMP facility, which develops and manufactures investigational cell therapy and biologic products to support FDA-approved early phase clinical trials. 20,000 square feet of GMP-grade cleanrooms, laboratories, material and cryogenic storage are located in the Fitzsimmons Innovation Community just across the street from University of Colorado Anschutz Medical Campus research laboratories plus the adult and pediatric hospitals (http://www.gatesbiomanufacturing.com). The facility currently produces CAR-T cells and other cell therapy biologics for clinical trials as well as protein-based biologics. The mission-based manufacturing facility serves academic researchers, clinicians and early-stage biotechnology companies, focuses on translation of discoveries into clinical-grade products, and completes the medical ecosystem from basic research through early commercialization. The CU Anschutz campus is strategically expanding into the use of cell-based therapies to treat disease.
About the University of Colorado Anschutz Medical Campus
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu.