On January 4, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has been granted a U.S. patent (11,207,350 B2) for a novel natural killer (NK) cell therapy composition and method for treating cancer that combines the company’s genetically modified NK-92 cells with CD16 receptors to enhance binding and activity of monoclonal antibodies (Press release, ImmunityBio, JAN 4, 2022, View Source [SID1234598077]). The combination of these engineered NK-92 cells with current monoclonal antibody therapies has the potential to augment the overall cytotoxic effects of monoclonal antibody treatment alone and help to address relapse by bolstering the patient’s own natural immune system response.
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ImmunityBio’s NK-92 cells are specifically modified versions of the NK cells that are a core element of the human immune system. First discovered in the blood of a non-Hodgkins lymphoma patient, these cells retain most of the activating receptors of NK cells but lack the major inhibitory receptors, giving them higher baseline cytotoxicity against tumor cells. The cells have been included in more than 450 published papers covering a wide range of research and they are currently being studied in clinical trials for pancreatic cancer, triple-negative breast cancer, and non-Hodgkin lymphoma.
The off-the-shelf NK cell platform can be easily expanded, genetically modified and cryopreserved. By inserting chimeric antigen receptors (CARs) in the NK-92 cells, they have the potential for multi-specific killing including direct NK cell killing via stress ligands, CD16-mediated killing via tumor-targeted antibodies, and CAR-mediated killing.
The patent, which protects this therapeutic approach for 20 years from its original filing, covers the use of these NK-92 cells in conjunction with the mAbs that are a standard of care in many cancer cases.
"While monoclonal antibodies have significantly improved the clinical outcomes in patients with cancer, many of these patients ultimately relapse," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "A growing body of research suggests that clinically meaningful responses to these antibody therapies is dependent upon the overall health of the patient’s own natural killer cells and whether the cells express the high-affinity variant of the CD16 receptors, which are found on the surface of natural killer cells. Only about 10% of NK cells in the blood of healthy people have the high-affinity CD16 receptors for monoclonal antibody binding—the majority of NK cells have the intermediate- and low-affinity receptor—therefore an infusion of these NK-92 cells engineered with a high-affinity CD16 receptor supercharges the monoclonal antibodies, potentially enabling the antibodies to be therapeutically more effective in combination with the killing activity of these engineered NK-92 cells."
The new patent adds another asset to ImmunityBio’s strong intellectual property portfolio, which includes more than 1,100 issued and pending patents worldwide across multiple categories including biologics, vaccine vectors, natural killer cells, and GMP devices. Patents for key areas such as N-803 (Anktiva), adenovirus vaccine vectors, yeast vaccine vectors, NK-92 cells and therapies extend to 2036 and beyond.