The ImmunityBio plant off Route 5 in Dunkirk.

Dunkirk’s state-of-the-art facility is expected to play a significant role in the production of a new cancer-fighting drug developed by ImmunityBio Inc.

On Tuesday, the company announced in a news release that the drug substance has been completed and successfully qualified for “fill finish,” sufficient for 170,000 doses of 400mcg ANKTIVA.

Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the company’s own drug substance and fill-finish manufacturing plants in California and here in Western New York.

The drug product will be filled at the Dunkirk plant, a 400,000 square foot state-of-the-art building in which the fill-finish equipment has been purchased and is in the process of being installed.

Since the company’s merger with NantKwest in 2021, ImmunityBio has made significant capital investments in personnel, plants, and equipment to ensure global capacity of ANKTIVA drug product for both the commercial launch, as well as clinical trials in bladder cancer and other tumor types in its pipeline. Both drug substance and drug product facilities are nearing completion to ensure sufficient capacity and multiple manufacturing sites for ANKTIVA in its approved indication, as well as for clinical trials and future indications.

“When we began the development of ANKTIVA and enlisted our contract manufacturer, we believed that the manufacture of a biologic as complicated as ANKTIVA was best served by having multiple sites of manufacturing, including in-house capacity and external partners,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “Our investment since 2021 in our facilities, together with the agreement entered into with the Serum Institute of India (SII) ensures that both ANKTIVA and BCG could be available at scale on a global basis.”

There was no indication offered as to how many jobs will be added to the local plant at this time.

In 2020, the company began construction of a state-of-the-art biological manufacturing plant in California with large-scale bioreactors for ANKTIVA drug substance and it is anticipated to be completed in the next 12 to 18 months. The large-scale equipment needed for GMP biological manufacture, with long-lead times, are on site and will be installed in the next 12 months. Upon completion, this 100,000 square foot manufacturing site will have the capacity to manufacture drug substance sufficient for a million doses of ANKTIVA a year.

These infrastructure capacity plans that included Dunkirk were initiated in anticipation of the approval of ANKTIVA in combination with treatment for non-muscle invasive bladder cancer to ensure that ImmunityBio has sufficient drug product supply, not only for the first commercial launch of ANKTIVA but for other clinical trials and indications.

“Our belief in the importance of this molecule and its potential to evolve immunotherapy to the next level, guided our strategic plan to invest for the future with anticipation of ANKTIVA’s approval,” said Rich Adcock, CEO & President ImmunityBio. “I’m grateful for our employees and our investors who have supported and believed in our commitment to invest for our long-term vision and future.”

ImmunityBio completed its acquisition of the leasehold interest in the pharmaceutical manufacturing space in Dunkirk from global pharmaceutical company Athenex, Inc in February 2022. The production location includes clean rooms for upstream and downstream manufacturing activities, as well as fill and finish and large-scale lyophilization capabilities.

In October 2022, ImmunityBio announced layoffs of staff while noting interior work at the location off Route 5 needed to be upgraded.

New York state provided $200 million for the Dunkirk plant in 2016, amid a great deal of fanfare. Promises for hundreds of jobs at the site were never met, as Athenex faced severe and ultimately unsolvable financial difficulties.