ImmunityBio (NASDAQ: IBIO) is drawing investor attention after revealing that five newly granted U.S. patents will shield its Anktiva-plus-BCG combination therapy for non-muscle invasive bladder cancer (NMIBC) from competition until at least 2035. This intellectual property update follows the company's announcement of an exclusive U.S. supply agreement with Japan BCG Laboratory for the Tokyo-172 strain of Bacillus Calmette-Guérin (BCG).
The company's shares were trading at $7.97 just before Monday's Nasdaq opening, unchanged from Friday's close of $7.97. The stock had slipped 2.2% on Friday on volume of 11.3 million shares. Pre-market activity was active, though regular trading had not yet commenced.
ImmunityBio is working to expand the approved uses of Anktiva (nogapendekin alfa inbakicept-pmln) and reduce its reliance on existing BCG suppliers. BCG is a live bacterial immunotherapy administered directly into the bladder for certain forms of bladder cancer. The exclusive deal with Japan BCG Laboratory gives ImmunityBio the rights to develop, import, and commercialize Tokyo-172 BCG in the U.S., a strain that remains investigational and not yet approved by the FDA.
Japan BCG Laboratory President Seiichi Inoue expressed enthusiasm about the partnership, while ImmunityBio CEO Richard Adcock highlighted that the deal provides a "second potential BCG source" for the U.S. market. The company intends to engage with the FDA to establish a regulatory pathway for Tokyo-172 BCG, with plans to file a Biologics License Application (BLA) as the sole applicant. Phase III data from the SWOG S1602 trial demonstrated that Tokyo-172 BCG was non-inferior to the standard TICE BCG strain.
The newly issued patents specifically cover methods of treating NMIBC, compositions of matter, and two-vial kits that combine Anktiva with BCG. Patrick Soon-Shiong, founder and executive chairman of ImmunityBio, described the drug pairing as the "backbone of our bladder cancer franchise."
Anktiva received FDA approval in April 2024 for use with BCG in adults with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. The approval was supported by data showing a 62% complete response rate, with 58% of responders maintaining their response for at least 12 months. The competitive landscape includes Merck's Keytruda and Ferring's Adstiladrin, both approved for similar indications.
Financially, ImmunityBio reported first-quarter net product revenue of $44.2 million, a 168% increase year-over-year. As of March 31, the company held $380.9 million in cash, cash equivalents, and marketable securities. However, the net loss for the quarter was $632.8 million, largely driven by non-cash fair-value changes, while the adjusted net loss stood at $86.2 million.
Risks remain, including potential FDA rejection of Tokyo-172 BCG or new supplements, possible patent challenges, and a March FDA warning regarding promotional practices for Anktiva. Piper Sandler analyst Edward Tenthoff indicated that ImmunityBio can likely comply with the FDA's concerns, but the regulatory messaging risk persists.
Market conditions are also uncertain, with U.S. stock-index futures slipping Monday amid rising Treasury yields and oil prices, which could weigh on biotech valuations. ImmunityBio plans to provide further updates on the regulatory pathway for Tokyo-172 BCG, including discussions with the FDA and BLA timing.
