ImmunityBio Inc., the Culver City-based immunotherapy company founded by billionaire Patrick Soon-Shiong that last month won Food and Drug Administration approval for its lead drug candidate Anktiva, has wasted no time moving that drug to market and laying the foundation for its next application of the drug.

Within two weeks of the FDA’s April 22 approval, ImmunityBio announced on May 7 that it had 170,000 doses of the drug ready to ship to urology practitioners to be used to treat a common form of bladder cancer. The company also announced it was rapidly scaling up several manufacturing facilities to be able to produce a million doses annually by the end of next year.

Concurrently, ImmunityBio announced a partnership with an Indian drug manufacturer, the Serum Institute of India, to secure an independent supply of the Bacillus Calmette-Guerin vaccine. Anktiva must be delivered in tandem with this vaccine to bladder cancer patients, and there have been chronic shortages of the vaccine.

“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,” Soon-Shiong, the company’s executive chairman, said in the announcements. 

Meanwhile, ImmunityBio also announced that it had set up a June meeting with the FDA to discuss “a path to registration filing” for Anktiva to treat patients with non-small cell lung cancer – part of the company’s grand plan to obtain approvals for the drug to treat a wide variety of cancers.

Soon-Shiong pointed to positive results from clinical trials of Anktiva across multiple tumor types.

“We are excited that these results continue to demonstrate the broad potential for Anktiva across multiple tumor types and its role as the next-generation immunotherapy,” he said. 

Investors greeted this flurry of announcements with optimism, sending ImmunityBio shares surging 62% since April 25; shares closed on May 7 at $8.26. 

But ImmunityBio still faces plenty of challenges as it attempts to win widespread adoption of its Anktiva therapy. For starters, the bladder cancer treatment market is dominated by the blockbuster immunotherapy drug Keytruda, developed and manufactured by Darmstadt, Germany-based pharma giant Merck Group. Keytruda was reported to have more than $25 billion in sales last year, comprising nearly half of Merck’s $60 billion in revenue.

Soon-Shiong maintains that Anktiva has been shown to keep cancers in remission for longer periods than Keytruda or other drugs – what he termed “cancer-free overall survival of great duration.” 

And then there’s the fight to get insurance companies to cover this new drug. According to one of the announcements from ImmunityBio, the full retail price for Anktiva is about $36,000 per dose and the treatment regimen involves well over a dozen doses over a two-year period. ImmunityBio, like other drug manufacturers, has a program offering steep discounts for patients with limited or no insurance coverage for the drug. But unless there is widespread insurance coverage where patient copays are in the neighborhood of $100, the drug is likely to fail to gain significant traction.