Culver City-based ImmunityBio Inc. has started to take its Anktiva immunotherapy drug global.

Last month, the United Kingdom Medicines and Healthcare Products Regulatory Agency approved Anktiva for treatment alongside a bacterial therapy for certain bladder cancer patients. This is the first approval for Anktiva outside the United States, where it received approval in April of last year.

Anktiva works by stimulating the production of “natural killer” and T-cells – immune cells that kill cancer cells. ImmunityBio has paired Anktiva with a bacterial agent called Bacillus Calmette-Guérin, or BCG. That benign bacterium induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients.

But in roughly one-third of patients, BCG fails to clear the cancer, and in about half the remaining cases, the cancer returns in a relatively short time. In these instances, according to ImmunityBio, adding in Anktiva to the BCG treatment significantly boosts the chances of clearing the cancer.

Getting the sign offs

ImmunityBio first submitted Anktiva for approval in the United States with the FDA in late 2023. Initially, the FDA rejected the drug, citing concerns about the quality of the third-party manufacturing process. ImmunityBio addressed those concerns and later resubmitted the drug; this time, the FDA approved it. 

ImmunityBio announced last week that the Michael DeBakey Department of Veterans Affairs Medical Center in Houston recently became one of the first VA hospitals in the nation to provide Anktiva treatments.

ImmunityBio has also begun applying for broader use of Anktiva, both to treat other conditions and diseases in the U.S. and to other countries. The U.K.’s Medicines Agency is the first of what the company hopes will be many approvals in the international arena.

“With the MHRA’s authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal,” Patrick Soon-Shiong, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, said in the company’s announcement.

Next up abroad for ImmunityBio is the European Medicines Agency, which oversees drug applications for the 27 European Union member states, as well as Iceland, Norway and Liechtenstein. Immunity submitted its application to the EMA in January.

Also last week, ImmunityBio reported favorable early-stage clinical trial results for a new cell therapy drug it is developing to treat a type of non-Hodgkins lymphoma. The news sent ImmunityBio shares up 14% on Aug. 13 to close at $2.82.