ImmunityBio Inc. scored a win earlier this month. The Culver City-based company announced that the U.S. Food and Drug Administration has granted “expanded access authorization” for the use of the company’s main drug platform, Anktiva, to treat lymphopenia in patients who have gone through standard cancer treatments.
Lymphopenia is a condition where the body’s supply of lymphocyte immune cells is depleted, limiting the ability to fight cancerous tumors. There are various causes for the condition, which can be either inherited or acquired. HIV, the virus that can lead to AIDS, and Covid-19 are among the most prevalent acquired causes.
Anktiva has been found to boost lymphocyte production, and it is the first drug approved for this purpose, according to ImmunityBio.
“We are entering a new era in oncology where the goal is not only to target the tumor but to protect and empower the immune system itself,” said Patrick Soon-Shiong, the billionaire physician and bioscience entrepreneur who founded ImmunityBio roughly a decade ago. With this approval, “we can now offer hope to patients with solid tumors who have exhausted standard options.”
Soon-Shiong said this approval of Anktiva to treat lymphopenia ties directly into the company’s mission “to transform cancer care by reversing the immune collapse that often leads to progression and mortality by enabling the body to serve as a factory for the regeneration and reconstitution of the lymphocytes key to immunogenic cell death of the tumor.”
The approval also grants ImmunityBio access to what appears to be an untapped market to treat lymphopenia by specifically boosting body’s production of lymphocytes. Other treatments have focused on costly bone marrow/stem cell transplants or immunoglobin shots.
“This is the first lymphocyte stimulator ever,” said Richard Adcock, chief executive of ImmunityBio. “And it can be applied for all tumor types.”
Seeking multiple expanded uses of Anktiva
For ImmunityBio, this is second approval for Anktiva. The first occurred in April of last year to treat a form of bladder cancer. But in that instance, ImmunityBio entered a market already occupied with competitors, chiefly Rahway, New Jersey-based Merck & Co.’s Keytruda.
And it’s part of ImmunityBio’s strategy of obtaining FDA approvals for a whole string of expanded uses for Anktiva over the next few years, according to Adcock. Expanded uses for existing drugs are a tried-and-true method of growing revenue for pharmaceutical companies at a lower cost. The basic research is in most cases already done, as is a lot of the clinical trial work demonstrating the safety of the drug in question.
But it’s not always smooth sailing with expanded uses, as ImmunityBio found out last month when the FDA rejected its bid for an expanded use of Anktiva to treat a broader category of bladder cancer patients than the first approval allowed. ImmunityBio executives immediately asked for a meeting with FDA officials to gain a further understanding of the rejection. There has been no announcement of the FDA granting a meeting.
News on May 5 of that FDA rejection sent ImmunityBio shares down 18% within hours, though the stock had rebounded within the next couple weeks.
The stock price movement was more muted immediately after the FDA’s clearance of the expanded use for lymphopenia. But the stock then climbed steadily to $3.44 a share one week after the announcement, nearly 30% above its close on June 2.
