On July 27, 2021 ImmunityBio, Inc., a publicly traded immunotherapy company, reported that it has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine (U.S. Patent 11,071,774) (Press release, ImmunityBio, JUL 27, 2021, View Source [SID1234585222]). This novel investigational treatment for cancer is designed to bolster a patient’s own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer’s resistance, and induce long-term T-cell memory to induce remission across multiple tumor types.
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The NCV has been in clinical testing since 2017 and has its foundation in earlier work that led to the development of Abraxane, an albumin nanoparticle that enables the delivery of paclitaxel to the tumor microenvironment. The basis of the orchestrated, multi-modal NCV approach is delivery of chemotherapy agents in a ‘metronomic’ fashion—low doses spread over time—to expose the tumor to immune system recognition by release of tumor-specific antigens. The tumor antigens are then targeted by antigen-specific T-cells activated via ImmunityBio’s adenoviral- and yeast-based vaccine vectors. T cell activation can then be enhanced further by infusion of the company’s proprietary, off-the-shelf, natural killer cell platform and its IL-15 superagonist N-803 (Anktiva).
To study the safety and early efficacy signals across multiple tumor types, the company has launched a series of Quantitative Lifelong Trials (QUILT). To date, the NANT Cancer Vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial studying the NCV in metastatic pancreatic cancer patients. Enrollment of Cohort C, patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.
"We are excited to be developing this orchestrated approach to activate as many elements of the immune system that we can and overcome cancer’s ability to evade the immune system. Our hypothesis is that by revealing tumor antigens to the immune system, we activate tumor-specific T cells and targeted natural killer cells to eradicate tumors by what is known as immunogenic cell death," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "The issuance of the NANT Cancer Vaccine patent is recognition of this innovative approach to therapy that not only potentially provides long-term immune system protection from cancer, it does so with a reduced risk of the toxicity risk that comes with using high-dose chemotherapy and radiation. This closely aligns with the FDA’s recent ‘Project Optimist’ guidelines for exploring lower doses of therapeutic agents."
ImmunityBio’s intellectual property portfolio 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 2035 and beyond.