ImmunityBio receives five US patents for cancer drug combination

ImmunityBio Inc. (NASDAQ: IBRX) announced it has received five United States patents covering the combination of its IL-15 receptor agonist ANKTIVA with Bacillus Calmette-Guérin for cancer treatment, with patent terms extending through at least 2035.

The patents cover methods of treating non-muscle invasive bladder cancer, including BCG-naïve disease, defined-dose pharmaceutical compositions matching the approved ANKTIVA plus BCG intravesical regimen, and two-vial commercial kits. The patent numbers are 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432.

ANKTIVA is currently approved with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The company has a pending supplemental biologics license application for BCG-unresponsive papillary-only disease and is conducting the QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve disease.

The patents also cover ImmunityBio's exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo strain of BCG. The Tokyo-172 BCG strain demonstrated non-inferiority versus TICE BCG in a Phase III trial with 984 randomized patients with BCG-naïve high-grade non-muscle invasive bladder cancer.

The patent portfolio includes composition-of-matter protection for both wild-type and mutant IL-15 plus BCG combinations, method-of-treatment claims, specific intravesical dosing regimens, and commercial kit configurations that physicians administer.

ImmunityBio reported 700% year-over-year revenue growth, according to the press release statement.

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