In a major stride towards addressing bladder cancer, ImmunityBio, Inc. (NASDAQ: IBRX) has recently completed the manufacturing of a drug substance that promises to significantly bolster the treatment landscape. The company announced the successful production and release of a batch sufficient for 170,000 doses of ANKTIVA, a groundbreaking immunotherapy agent, at its state-of-the-art Good Manufacturing Practice (GMP) facility in Dunkirk, New York.
This milestone is part of ImmunityBio’s broader strategy to scale up production capabilities in anticipation of increased demand following recent regulatory approvals. The completion of this manufacturing phase not only showcases the company’s commitment to high standards in production but also aligns with its strategic partnerships aimed at expanding access to essential treatments globally. Notably, a collaboration with the Serum Institute of India (SII) has been pivotal, ensuring a substantial supply of both ANKTIVA and Bacillus Calmette-Guerin (BCG), another key therapeutic agent.
The Dunkirk facility, sprawling over 400,000 square feet, is poised to play a crucial role in ImmunityBio’s supply chain. With fill-finish equipment installation underway, the site is expected to reach full operational capacity within the next 12 to 18 months, ultimately having the ability to produce up to a million vials annually. This scale-up is critical as it supports the company’s plans for the commercial launch of ANKTIVA, as well as ongoing and future clinical trials across a range of tumor types.
Looking ahead, ImmunityBio is not resting on its laurels. A parallel expansion effort at a new facility in California is also in the works. This site is designed to feature large-scale bioreactors and other advanced biomanufacturing technologies, which are crucial for the production of biologic therapies like ANKTIVA. Expected to be completed in the same 12-18 month timeframe as the Dunkirk site, it reinforces the company’s preparedness for large-scale production needs.
The proactive expansions and strategic partnerships underscore ImmunityBio’s commitment to enhancing cancer treatment options and accessibility. With these developments, the company is well-positioned to meet the anticipated global demand for ANKTIVA, marking significant progress in the fight against bladder cancer and potentially other cancers in the future.
