Policy & Regulation
ImmunityBio's Novel Immunotherapy NANT Cancer Vaccine Currently Being Studied in Multiple Clinical Trials Is Awarded a US Patent
28 July 2021 - - US-based immunotherapy company ImmunityBio, Inc has been granted a patent by the US Patent and Trademark Office for its proprietary NANT Cancer Vaccine (US Patent 11,071,774), the company said.

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.

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 1Q22.

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.

ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases.

The company's immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

ImmunityBio has a comprehensive immunotherapy pipeline with more than 40 clinical trials (company sponsored or investigator initiated), of which 25 are at Phase II and III stage of development, across 19 indications in solid and liquid cancers and infectious diseases.

Currently 17 first-in-human immunotherapy agents are in clinical testing and, to date, over 1,800 patients have been studied with our antibody cytokine fusion proteins, albumin chemo immunomodulators, Adeno and yeast vaccines and our off-the-shelf natural killer cell products.

Anktiva (ImmunityBio's lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the US Food and Drug Administration for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

The company's platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus and yeast vaccine technologies, and off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells. ImmunityBio is currently developing a dual construct COVID-19 vaccine candidate using its hAd5 platform.

ImmunityBio is a producer of cryopreserved and clinical dose forms of off-the-shelf natural killer cell therapies.

The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R and D, clinical trial, and regulatory operations and development teams.
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