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Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.
Nkarta, a clinical-stage biotechnology company focused on allogeneic, off-the-shelf natural killer (NK) cell therapies, announced on July 14, 2021, that it has signed a lease agreement for a facility to support research and development and future commercial manufacturing of its cell therapy pipeline at its South San Francisco, Calif., site. The new facility will also serve as the company’s headquarters.
The manufacturing facility will be custom designed to complement the company’s technology platform and optimize production of multiple off-the-shelf NK cell therapy investigational products. Nkarta plans to produce materials for potential pivotal clinical trials and commercial launch at the new 88,000-ft2 scalable facility. Further planned production expansion will build on Nkarta’s foundational manufacturing, operational, and process development expertise.
Earlier this year, Nkarta completed the construction and qualification of a 2700-ft2 current good manufacturing practice facility in South San Francisco for clinical manufacturing. The company is currently manufacturing clinical supply for its planned Phase I study for its candidate, NKX019, which is expected to start in the second half of 2021. The company also plans to transfer the production of NKX101 and other proprietary platform materials to the clinical manufacturing facility in the future.
The new facility, meanwhile, will be built-out as a multi-product facility and is expected to be operational by the end of 2023. At full capacity, this manufacturing center is expected to have the flexibility to produce commercial supply of multiple cell therapy products.
“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,” said Paul J. Hastings, president and CEO of Nkarta, in a company press release. “As we advance our NKX101 and NKX019 clinical programs and enhance our proprietary platform with exciting new capabilities like CRISPR [clustered regularly interspaced short palindromic repeats] Cas9 genome engineering, we believe our expanded footprint will drive continued operational excellence and accelerate the development of transformative NK cell therapies for a broad range of cancers.”