ImmunityBio scored an FDA approval for its once-rejected drug combo for bladder cancer, the biotech announced Monday, sending its stock up nearly 25% in premarket trading.
The agency approved the drug Anktiva, an IL-15 agonist, in combination with Bacillus Calmette-Guérin to treat patients with a subtype of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). ImmunityBio’s stock $IBRX was trading over $6 before the market opened.
ImmunityBio said that the drug combo is expected to be available in the US by the middle of May.
The FDA first handed down a complete response letter in May 2023, citing deficiencies related to an inspection of a third-party contract manufacturer. ImmunityBio resubmitted its BLA in October with updated follow-up data from two trials, one of which showed a complete remission rate of 100% in nine patients, who all have NMIBC with carcinoma in situ with or without Ta or T1 disease.
Patrick Soon-Shiong“ANKTIVA not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells,” said Patrick Soon-Shiong, ImmunityBio’s global CSO and CMO, in a statement. “This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone.”
Following the approval, ImmunityBio will receive $100 million thanks to a royalty deal and private placement with Oberland Capital announced in January. ImmunityBio, which received $200 million upfront, said at the time that the cash would go toward commercializing its Anktiva combo as well as running other clinical trials expanding Anktiva into multiple solid tumors. It’s also looking to grow its pipeline within the urological cancer space.
In exchange for the investment, Oberland will get tiered single-digit royalty payments on net sales of ImmunityBio’s products. The deal also included selling off 2.4 million shares to Oberland in a private placement for $10 million with the option for Oberland to purchase another $10 million of common stock in the future.
Editor’s Note: This story has been corrected to change the CRL date to May 2023.