Nkarta signs its name to an ambitious future with manufacturing hub for not one but multiple marketed drugs
Riding science out of Dario Campana’s famed lab in Singapore, West Coast biotech Nkarta has been a high-profile entry into the race for the industry’s first natural killer cell-based therapy. The biotech, miles away from a potential approval, is doubling down on its own ambition and setting up a manufacturing facility of the future far in advance.
Nkarta has signed a lease on an 88,000-square-foot facility in South San Francisco that will act as the biotech’s new headquarters as well as the home of its commercial manufacturing operations, the company said Wednesday.
Nkarta, which is developing off-the-shelf NK cell immunotherapies for cancer, currently churns supply out of a small, 2,700-square-foot clinical manufacturing facility that was completed earlier this year at its existing site in South San Francisco. But as the biotech enrolls a Phase I clinical test for NK cell candidate NKX101, which targets NKG2d ligands on tumor cells, and approaches the clinic with another, Nkarta realized its humble surroundings didn’t match its ambitions as a multidrug pharma.
Now, the biotech’s new site, which is expected to go online in late 2023, will be the incubator for Nkarta’s goal of bringing a slate of drugs over the finish line in what would be a significant achievement given there are no approved NK cell therapies.
All of Nkarta’s candidates, which are engineered to express a chimeric antigen receptor (CAR) and a membrane-bound IL-15 cytokine to spur the NK cells’ growth and activity, use cells derived from healthy donors and can potentially be produced at a fraction of the cost at commercial scale of other cell therapies, the company said. Nkarta attributed the cost gap to its proprietary manufacturing platform, which can theoretically produce hundreds of individual doses off of a single run, as well as optimized freezer storage for off-the-shelf use.
“Our goal is to ensure that cost-effective, commercial-scale production of cell therapies can be made available widely and rapidly to the cancer patients who need them, and we expect this new facility will enable us to do just that,” CEO Paul Hastings said in a statement.
In addition to NKX101, which is currently enrolling a Phase I trial against AML, Nkarta is preparing the way for NKX019, which targets CD19, to hit the clinic later this year. Meanwhile, the company thinks its newest facility could provide enough elbow room to advance the pipeline into exciting new areas, particularly a CRISPR/Cas9 application for its NK cell tech, the company said in a statement.
The path there has already been paved after Nkarta signed a discovery deal in May worth an undisclosed amount of cash upfront to partner with CRISPR Therapeutics, the biotech using tech pioneered in part by gene editing maven Emmanuelle Charpentier. The collaboration will look to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings previously told Endpoints News.
There’s some overlap in terms of what both biotechs are trying to do. In October, CRISPR announced two of four patients given a specific dose of its CAR-T candidate for CD19+ B cell malignancies achieved complete responses (the results, however, were marred by the death of a patient in a higher dose cohort).
“While we are bullish about our allogeneic CAR-T approach, we believe that NK cells can be an important part of future oncology therapies,” CRISPR CEO Samarth Kulkarni said in an email.