Strategic Manufacturing Partnership Announced Between Gates Biomanufacturing Facility and Nkarta
The partnership includes the continued manufacture of therapeutic NK cells for the ‘cell therapy pioneer’, Nkarta.
The partnership is described to include the manufacture and provision of clinical supply of therapeutic NK cells, NKX101.
NKX101 is Nkarta’s ‘off-the-shelf’ investigational immunotherapy for relapsed/refractory acute myeloid leukaemia (AML) or higher-risk myelodysplastic syndromes (MDS).
Currently in a Phase I clinical trial, the dose-finding study is reported to be conducted in two parts. The first will be “dose finding with two dosing regimens, utilising modified ‘3+3’ enrolment schema”, and the second will expand dosing to better assess safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumour response.
Ralph Brandenberger, Senior Vice President at Technical Operations for Nkarta commented:
“Our partnership with the Gates Biomanufacturing Facility is an excellent fit. Gates Biomanufacturing Facility’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 I clinical trial. We look forward to continuing our important collaboration.”
NKX101 NK cells are developed from the peripheral blood of healthy donors, which are then engineered with membrane-bound interleukin 15 and a chimeric antigen receptor (CAR). This level of engineering enhances targeting and killing of tumour cells. Expansion of these engineered NK cells at scale generates an abundant supply of does.
The Gates Biomanufacturing Facility reports that it is one of the only GMP facilities located on a major academic research and clinical campus that has capacity for the manufacture of cell and protein-based therapies for both academia as well as external biotechs.
“Collaborating with a publicly-traded company with the reputation and calibre of Nkarta marks an important milestone for Gates Biomanufacturing Facility. 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,” concluded Gates Biomanufacturing Facility Executive Director, Matthew Seefeldt.