ImmunityBio Completes GMP Manufacturing for 170,000 Doses of ANKTIVA®

ImmunityBio, Inc. (NASDAQ: IBRX) recently announced significant progress in the manufacturing of its ANKTIVA® drug substance. The company has successfully completed and qualified the drug substance for "fill finish" operations, ensuring the production of 170,000 doses of 400mcg ANKTIVA. This development, alongside a new partnership with the Serum Institute of India (SII) for BCG availability, positions ImmunityBio with a substantial initial supply of ANKTIVA for both commercial use and clinical trials ahead of their own manufacturing plants becoming fully operational in California and New York.

Since merging with NantKwest in 2021, ImmunityBio has heavily invested in personnel, facilities, and equipment to ensure a global supply capacity for ANKTIVA. The drug substance (DS) and drug product (DP) manufacturing facilities are nearing completion, which will provide sufficient capacity and multiple GMP manufacturing sites for ANKTIVA’s approved indications and other future clinical trials.

Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, emphasized the strategic plan to have multiple manufacturing sites, including in-house capabilities and external partners, for the production of ANKTIVA. He stated that their investment in facilities and the agreement with the Serum Institute of India would ensure the global availability of both ANKTIVA and BCG.

In 2020, ImmunityBio initiated the construction of a cutting-edge biological manufacturing plant in California, equipped with large-scale bioreactors for ANKTIVA drug substance production. This facility is expected to be completed within the next 12 to 18 months. The necessary large-scale equipment for GMP biological manufacturing, which has long lead times, is already on site and will be installed within the next year. Once operational, this 100,000 square foot site will have the capacity to produce drug substance sufficient for a million doses of ANKTIVA annually.

Meanwhile, the filling of the drug product will take place at the Dunkirk, New York facility, a state-of-the-art GMP site spanning 400,000 square feet. The fill-finish equipment for this site has been acquired and is currently being installed.

These infrastructure initiatives were launched in anticipation of ANKTIVA’s approval for use in combination with BCG for non-muscle invasive bladder cancer, specifically carcinoma in situ (CIS). This will ensure that ImmunityBio has an adequate supply of the drug product for the initial commercial launch as well as for ongoing clinical trials and other future indications.

Rich Adcock, CEO & President of ImmunityBio, expressed gratitude towards the company's employees and investors for their support and belief in the long-term vision and commitment to investing in the future. He highlighted the potential of ANKTIVA to revolutionize immunotherapy and emphasized the importance of their strategic investments in anticipation of the drug’s approval.

ImmunityBio continues to develop next-generation therapies and vaccines to enhance the natural immune system against cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms aim to create durable and safe protection against diseases. ANKTIVA, designated as an FDA Breakthrough Therapy, is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer, activating natural killer cells, T cells, and memory T cells for prolonged responses. The company is leveraging its scientific and technological platforms to develop potential cancer vaccines and other immunotherapies that could reduce or eliminate the need for conventional high-dose chemotherapy.