CULVER CITY, Calif.--(BUSINESS WIRE)--NantKwest Inc. (Nasdaq:NK), a pioneering, next-generation, clinical-stage immunotherapy company focused on harnessing the unique power of the immune system using natural killer (NK) cells to treat cancer today announced the clinical implementation of the company’s haNK cell therapy program to human clinical trials with the first participants treated in the first-in-human, Phase I haNK cell therapy clinical trial targeting a wide range of cancer types.
"Only about 10% of individuals are born with a high affinity Natural Killer cell type needed for the maximum killing effect when combined with monoclonal antibodies widely used in clinical practice today such as Trastuzamab, Rituxan and Avulamab. To maximize tumor cell death by this mechanism known as ADCC we have engineered our off the shelf natural killer cell line with a high affinity CD16 receptor. The potential for this haNK cell therapy is to improve patient outcomes for a significant percentage of the other 90% of individuals being treated with antibody therapy in a broad range of tumor types that can now be explored," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest.
Dr. Soon-Shiong added, “Our haNK cell therapy program was designed to optimize the unique properties of two immunotherapeutics (a cell based platform with a monoclonal antibody) used as a combination therapy. Multiple published preclinical studies have demonstrated the potential for haNK/antibody combinations to synergistically enhance antibody-dependent cell-mediated cytotoxicity (ADCC) activity, providing a sound scientific rationale for the transition of the haNK program into human clinical trials,” said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest.
haNK Cell Therapy Platform
NantKwest’s haNK cell therapy platform, an allogeneic, off-the-shelf therapy, was developed to optimize the key role of natural killer cells in mediating innate immunity, enhancing adaptive immune responses, and, specifically in the case of haNK, improve anti-tumor responses via antibody-dependent cell-mediated cytotoxicity (ADCC). ADCC is an important part of the human immune system associated with the synergistic interaction of natural killer cells with antibodies to directly kill a target cell that has been identified by an antigen-specific antibody. ADCC represents one of the key mechanisms that antibodies utilize to target and kill cancer cells.
Engineered to express the high-affinity variant of the CD16, high affinity Fc receptor (V158 FcγRIIIa), in multiple published preclinical studies, the combination of haNK cells with a variety of therapeutic antibodies has led to enhanced tumor cell killing when compared to use of the antibody as a single therapeutic agent, providing strong support for this novel combination immunotherapeutic approach.
haNK Phase I Study Background
The primary objective of the Phase I clinical study is to determine the safety of haNK cell therapy administered once per week in up to 16 patients with metastatic or locally advanced solid tumors. Secondary objectives include the determination of objective response rate, progression-free survival, overall survival, and any correlations between tumor molecular profiles (based on genomics, transcriptomics, and quantitative proteomics) and patient outcomes.
For additional information, including exclusion and inclusion criteria, contact information and other details, please visit www.clinicaltrials.gov, QUILT trial #3.028.
NantKwest (Nasdaq:NK) is a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases. NK cells are the body’s first line of defense due to the innate ability of NK cells to rapidly identify and destroy cells under stress, such as cancer or virally-infected cells.
NantKwest’s unique NK cell-based platform, with the capacity to grow active killer cells as a biological cancer therapy, has been designed to induce cell death against cancer or infected cells by three different modes of action: (1) Direct killing using activated NK cells (aNK) that release toxic granules directly into the cell through cell to cell contact, (2) Antibody-mediated killing using haNKs, which are NK cells engineered to incorporate a high affinity receptor that binds to an administered antibody, enhancing the cancer cell killing effect of that antibody, and (3) Targeted activated killing using taNKs, which are NK cells engineered to incorporate chimeric antigen receptors (CARs) to target tumor-specific antigens found on the surface of cancer cells.
Our aNK, haNK and taNK platform addresses certain limitations of T cell therapies including the reduction of risk of serious "cytokine storms" reported after T cell therapy. As an “off-the-shelf” therapy, NantKwest's NK cells do not rely on a patient’s own often compromised immune system. In Phase 1 clinical trials in patients with late stage cancer, NantKwest's NK cells have been successfully administered as an outpatient infusion therapy without any reported severe side effects, even at doses of 10 billion cells.
By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs that include a Phase 2 trial for a rare form of melanoma and the planned initiation of a clinical trial of NK cells targeted to breast cancer, we believe NantKwest is uniquely positioned to be the premier immunotherapy company and transform medicine by delivering living drugs in a bag and bringing novel NK cell-based therapies to routine clinical care. For more information please visit www.nantkwest.com.