Culver City, California, April 5, 2016—NantBioScience, Inc., is a biopharmaceutical company focused on the discovery of innovative treatments by developing molecularly targeted drugs, based on the molecular profile of the patient’s tumor, independent of the cancer’s anatomical type. NantKwest, Inc. (Nasdaq: NK), an affiliate of NantBioScience, is a clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using natural killer cells to treat cancer, infectious diseases and inflammatory diseases. NantBioScience announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the National Institutes of Health (NIH). Under the CRADA, NantBioScience and its affiliates, such as NantKwest, will work together to further develop their proprietary recombinant NK and monoclonal antibodies in monotherapy and in combination immunotherapies.
NantBioScience and NantKwest will be working with Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, NCI, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, NCI, and their teams to expand the preclinical and clinical development of recombinant NK cells and monoclonal antibodies, for use in combinations with other immunotherapeutics, such as vaccines and immune modulators, and other forms of cancer therapy. Both in vitro and in vivo preclinical testing will be conducted to further develop NantBioScience’s and NantKwest’s proprietary agents, and Phase I and II clinical studies will be carried out both at the NIH Clinical Center and in collaboration with investigators at extramural Cancer Centers.
“We look forward to combining our expertise with those at the NCI to create a multi-pronged paradigm-shifting immunotherapeutic attack of cancer,” said Patrick Soon-Shiong, MD, Chief Executive Officer, NantBioScience and NantKwest. “The worlds of genomics, proteomics, immunology, and immunotherapy have advanced and converged at an unprecedented speed. The studies conducted as part of this CRADA constitute an important component of our consortia of cancer researchers, clinicians, and private sector affiliates, to develop better therapies for cancer with a strong emphasis on immunotherapy. NantBioScience and its affiliates are composed of a seasoned team of scientists, including molecular and cellular biologists, computational scientists, clinicians, regulatory personnel, biostatisticians, and clinical development personnel who have contributed to the development of numerous clinical products. This CRADA is a significant milestone in our goal to develop novel combination immunotherapies for cancer patients. We are pleased that Dr. Schlom and Dr. Gulley and their cancer immunotherapy teams have partnered with NantBioScience and NantKwest to carry out these pioneering studies. This partnership explores and will hopefully verify that a multi-targeted approach to employing immunotherapies will lead to a substantial benefit for patients with a range of cancers and cancer stages,” added Dr. Soon-Shiong.
NantBioScience and NantKwest will manufacture the immunotherapeutic products for use in these studies, and the NCI will conduct both preclinical and clinical Phase I and II studies, which will potentially provide the rationale for randomized Phase III studies. The NCI will also carry out extensive immune analyses of the immune responses of patients undergoing clinical studies under this CRADA.
In the pharmaceutical area, NantBioScience has developed products ranging from small molecule synthetic compounds, natural products, viral-based delivery vehicles, nanoparticles, biologics including antibodies, and cell-based immunotherapeutics including the NK allograft platform.
In the diagnostic realm, NantBioScience has developed omics analyses platforms for treatment guidance, including a comprehensive tumor/normal genomic and transcriptomic analysis and quantitative, multiplexed proteomics. NantBioScience has also developed a sophisticated neo-epitope identification platform that can identify neo-epitopes applicable as tumor-specific antigens; these novel tumor-specific antigens then can be employed in the adenoviral and/or NK platforms. These omics analyses have recently been made available through CLIA/CAP certified laboratories.
About NantKwest Inc.
NantKwest (Nasdaq:NK), an affiliate of NantBioScience, is a 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.
NantKwest’s 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, NantKwest believes it is uniquely positioned to be the premier immunotherapy company and to transform medicine by delivering living drugs in a bag and bringing novel NK cell-based therapies to routine clinical care.
This news release contains forward-looking statements. The actual results could vary from those expected due to a variety of risks, including those set forth from time to time in NantKwest’s filings with the Securities and Exchange Commission. Neither NantBioScience nor NantKwest undertakes any obligation to publicly release the results of any of these forward looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.