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ImmunityBio, Inc. ((IBRX) announced today that the drug substance (DS) has been completed and successfully qualified for "fill finish" (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa inbakicept-pmln). 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 New York.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240507050323/en/
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 (DS) and drug product (DP) facilities are nearing completion to ensure sufficient capacity and multiple GMP 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."
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 12-18 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.
The drug product will be filled at the Dunkirk, New York facility, a 400,000 square foot state-of-the-art GMP facility in which the fill-finish equipment has been purchased and is in the process of being installed.
These infrastructure capacity plans were initiated in anticipation of the approval of ANKTIVA in combination with BCG for non-muscle invasive bladder cancer, carcinoma in situ (CIS), 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."
Posted In: IBRX
