After years of effort, delays and hundreds of millions of dollars of billionaire Patrick Soon-Shiong’s own money, last week provided a huge win for Soon-Shiong and his Culver City immunotherapy company ImmunityBio Inc.: the U.S. Food and Drug Administration finally approved its lead drug, Anktiva, to treat a common form of bladder cancer.
The agency’s approval, announced by ImmunityBio on April 23, clears the way for the company to begin distributing the drug to urologists and other providers as early as the middle of next month and receiving its first revenue from Anktiva sales weeks after that.
As an immunotherapy drug, Anktiva harnesses the body’s own immune cells to fight cancer. While scores of pharmaceutical and biotech companies are racing to develop their own immunotherapy drugs to keep various types of cancers at bay, Soon-Shiong said Anktiva goes farther than most: it has shown
in clinical trials the ability to eliminate bladder cancer cells in the body for at least four years.“We’ve changed the paradigm for looking at cancer,” Soon-Shiong said. “We’re not satisfied with the endpoint free survival. We’re trying to achieve the goal of cancer-free overall survival of great duration.”
The Food and Drug Administration approval, he said, represents “a validation of this novel concept: regardless of the tumor type, the cancer will be killed by ‘natural killer’ cells, T-cells and memory T-cells.”
Natural killer cells can destroy cancer and infected cells without having previously been exposed to the cancer of pathogen. They also can communicate with other immune cells to join in on the attack against cancer cells and pathogens.
A decade in the making
Soon-Shiong has been pursuing this approach to fighting cancer for well over a decade. He originally formed two companies in this effort: NantKWest to develop the natural killer cells and ImmunityBio to develop a combination therapy to deliver the natural killer cells to their target cancer cells. The two companies merged in March 2021 and the resulting company under the ImmunityBio banner went public that same month.
Clinical trials for the Anktiva drug were already under way by that point. But last May, the march to drug approval hit a major snag as the Food and Drug Administration rejected the drug, citing concerns about the third-party manufacturing process and requesting more data. That sent ImmunityBio’s stock plunging nearly 60%.
The ImmunityBio team then spent several months addressing the agency’s concerns and in late October resubmitted the Anktiva drug for approval. The agency accepted the drug for consideration and gave a decision deadline of April 23.
While that delay prompted Soon-Shiong to provide another $400 million cash infusion to the company, he said last week that it had a silver lining: the company used that delay period to build up a three-year stockpile of Anktiva and a $250 million cash reserve to market and distribute the drug. That’s why the company is now ready to take the drug to market within just three weeks of the agency’s approval rather than the several months that one would normally expect.
Details on the pricing for Anktiva and on pursuing different applications for the drug were not available by press time.
Meanwhile, for investors, the ride has been somewhat of a roller-coaster. As decision day approached, ImmunityBio’s stock rose in anticipation of a favorable outcome. When news of the decision began circulating last week, the stock surged 30% in pre-market trading. But by the end of the April 23 trading session, the gains were pared back to 11%. And on April 24, ImmunityBio shares fell 12%, giving back most of the recent gains.
By that time, some amateur analysts had begun putting Anktiva’s approval in perspective, noting that similar drugs from other companies are likely to come onto the market in the next few years, possibly limiting ImmunityBio’s window to reap major revenue from the drug.
