Nkarta Therapeutics isn’t slowing down. The biotech made an impressive IPO debut last July and then followed that up by dosing the first patient with its leading off-the-shelf cancer immunotherapy a few months later.
Now, the South San Francisco-based biotech says it’s moving into an 88,000-square-foot facility that will not only serve as its newest headquarters, but will support the research, development and future commercial manufacturing of its cell therapy pipeline.
Nkarta plans to design the center to optimize the assembly of its off-the-shelf natural killer (NK) investigational cancer therapies, the company said on Wednesday. The biotech didn't disclose the cost of the project.
The facility, a former Amgen facility, will be a “multi-product” manufacturing site and is scheduled to come online by the end of 2023, Nkarta said. At full capacity, the facility should be able to produce "commercial supply of multiple cell therapy products.”
With the new facility will eventually come new jobs, executives said. The company was a roughly 50-person team prior to the coronavirus pandemic, but now it has about 120 employees, said Nadir Mahmood, Nkarta's chief financial and business officer.
By the end of 2022, assuming Nkarta's growth stays on track, the company could hit a head count of nearly 200. The new manufacturing facility will likely bring in about 40 to 50 new jobs, in addition to other research and development hires, Mahmood said.
Cell therapies generally move through the FDA's regulatory process quickly, which is why the biotech is jumping on the new facility now, Nkarta CEO Paul Hastings said. The company believes it will pay off to manufacture its cells at the same site where they were developed during clinical trials.
"You don't want to be standing there without the ability to manufacture for commercial when your cells potentially come to market," Hastings told Fierce Pharma.
The biotech is currently in phase 1 testing for its leading treatment, NKX101, which uses NK cells from healthy donors that are engineered to express a chimeric antigen receptor (CAR) targeting NKG2D ligand in certain blood cancers.
Nkarta says its manufacturing process is able to produce “an abundant supply of NK cells” that are lower in cost than the current allogeneic and autologous cell therapies when made at scale. To get there, Nkarta uses a proprietary NKSTIM cell line that’s able to produce hundreds of individual doses from a single manufacturing run.
The cell line can freeze and store the CAR NK cells and is designed to “enable immediate, off-the-shelf administration to patients at the point of care,” Nkarta said.
The new headquarters will be in addition to a smaller 2,700-square-foot facility, also in the San Francisco area, that Nkarta just finished constructing.
Nkarta designed that site, which cost between $5 million to $6 million, to meet the needs of its research activities and early-stage trials, while the new facility will be reserved for phase 3 and commercial production, Hasting said.
At its smaller site, the company is currently producing supplies of another treatment known as NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies. The company expects phase 1 studies to kick off in the second half of the year. Meanwhile, production of NKX101 will be moved from a CDMO to in house, Hasting said.
On top of its own assets, Nkarta is also hard at work discovering potential CRISPR/Cas9 gene-edited cell therapies for cancer as part of its latest pact with gene-editing specialist CRISPR Therapeutics.
Under the deal, the companies will both develop and sell two CAR NK cell candidates, one targeting the CD70 tumor antigen and the “other target to be determined,” according to a joint statement.
Thanks to the forthcoming manufacturing facility, Nkarta CEO Paul Hastings said the company is confident the “expanded footprint will drive continued operational excellence and accelerate the development of transformative NK cell therapies for a broad range of cancers.”