ImmunityBio Inc (NASDAQ:IBRX) announced the grant of five U.S. patents covering its ANKTIVA plus BCG combination therapy for non-muscle invasive bladder cancer, a regulatory and commercial development that preceded a 4.5% rise in the companys shares in premarket trading on Monday.
The patent awards protect the use of ImmunityBios IL-15 receptor agonist ANKTIVA co-administered with Bacillus Calmette-Gu E9rin (BCG) and include coverage through at least 2035. According to the company, the portfolio spans core treatment methods and delivery forms tied to the ANKTIVA plus BCG intravesical regimen.
Patent scope and identifiers
The five U.S. patents listed by the company are U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432. Collectively, the patents cover:
- the fundamental method of treating cancer by administering BCG together with ANKTIVA;
- pharmaceutical compositions that combine BCG with IL-15 complexes; and
- a two-vial commercial kit format.
The portfolio specifically includes claims for treating non-muscle invasive bladder cancer, encompassing BCG-na EFve disease, and defined-dose pharmaceutical compositions that match the approved ANKTIVA plus BCG intravesical regimen.
Commercial and clinical linkages
ImmunityBio stated that the enhanced intellectual property position supports its commercial franchise for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer. The company also tied the patents to its regulatory pathway, noting relevance to a pending supplemental biologics license application for BCG-unresponsive papillary-only disease.
Additionally, the patents are relevant to the ongoing QUILT-2.005 registrational trial, which is evaluating ANKTIVA plus BCG versus BCG alone in BCG-na EFve disease. The portfolio further underpins the companys exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain.
ImmunityBio referenced Phase III SWOG S1602 results that demonstrated non-inferiority of Tokyo-172 BCG compared with TICE BCG on high-grade recurrence-free survival in 984 randomized patients with BCG-na EFve high-grade non-muscle invasive bladder cancer, positioning the Tokyo-172 supply agreement within the scope of the patented coverage.
Company commentary and financial context
Richard Adcock, the companys President and Chief Executive Officer, noted that ImmunityBio is generating 700% year-over-year revenue growth while expanding the clinical utility of ANKTIVA plus BCG across multiple non-muscle invasive bladder cancer settings.
This article presents the facts released by the company regarding the patents, related clinical programs, and the market reaction. It does not add any information beyond the company statements and trial results cited in the announcement.