Stock Moves Higher Following Patent Announcement
Shares of ImmunityBio (NASDAQ:IBRX) gained 4.5% in premarket trading on Monday after the company announced the issuance of five U.S. patents tied to its ANKTIVA plus BCG therapy for bladder cancer treatment.
The patents cover the combination of ImmunityBio’s IL-15 receptor agonist ANKTIVA with Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer and extend protection through at least 2035.
Patent Portfolio Covers Multiple Treatment Approaches
According to the company, the newly granted patents include protections for methods of treating non-muscle invasive bladder cancer, including BCG-naïve disease.
The intellectual property portfolio also covers defined-dose pharmaceutical formulations aligned with the approved intravesical ANKTIVA plus BCG regimen, as well as commercial two-vial treatment kits.
The newly issued patents are U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432.
These patents protect treatment methods involving administration of BCG together with ANKTIVA, pharmaceutical combinations using BCG and IL-15 complexes, and the company’s commercial kit structure.
Company Expands Commercial and Clinical Position
ImmunityBio said the expanded patent protection strengthens its commercial franchise for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer.
The portfolio also supports the company’s pending supplemental biologics license application targeting BCG-unresponsive papillary-only disease, as well as the ongoing QUILT-2.005 registrational study comparing ANKTIVA plus BCG against BCG alone in BCG-naïve patients.
Agreement With Japan BCG Laboratory Also Covered
The patent portfolio additionally supports ImmunityBio’s exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain.
The company noted that the agreement is backed by positive Phase III SWOG S1602 trial results showing non-inferiority of Tokyo-172 BCG versus TICE BCG in terms of high-grade recurrence-free survival among 984 randomized patients with BCG-naïve high-grade non-muscle invasive bladder cancer.
CEO Highlights Revenue Growth
Richard Adcock, President and Chief Executive Officer of ImmunityBio, said the company is generating 700% year-over-year revenue growth while continuing to broaden the clinical use of ANKTIVA plus BCG across multiple non-muscle invasive bladder cancer indications.