CULVER CITY, Calif.--(BUSINESS WIRE)--NantCell and NantKwest Inc. (NASDAQ:NK), two pioneering, next generation, clinical-stage immunotherapy companies focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients (ClinicalTrials.gov NCT03136406).
The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low-dose radiation and chemotherapy with molecularly-informed, tumor-associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.
“Abraxane, a nanoparticle albumin-bound (Nab) paclitaxel, was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years,” noted Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. “But we were not content just with the approval of Abraxane as being sufficient to transform this disease. In January 2016, we announced our Cancer Breakthroughs 2020 journey towards developing effective personalized cancer treatments to further harness the human body's innate immune system as a paradigm change to treating patients with cancer. Today's FDA clearance is a further step in our 25-year quest to develop this cancer vaccine that seeks to induce immunogenic cell death and orchestrate the innate and adaptive immune system of the patient through the delivery of molecularly informed, biological platforms. To our knowledge this is the first clinical study whereby protein nanoparticles (Nab) delivering low dose metronomic chemotherapy is combined with molecularly informed (GPS Cancer) tumor associated antigens activating dendritic and T cells by adenoviral and yeast vectors, and orchestrated with both endogenous (IL-15) and exogenous (off the shelf) activation of NK cells. This NANT Cancer Vaccine will be studied in patients suffering from all types of cancers and at all stages of disease in the coming 12 months, a Cancer Breakthroughs 2020 goal," Dr. Soon-Shiong added.
“Cancer has historically been one of the most complex challenges that the medical community has tried to combat,” said John Lee, MD, FACS, Senior Vice President of Clinical Development at NantKwest. “Receiving authorization from the FDA for the IND application for the NANT Cancer Vaccine is a testament to our novel immunotherapy approach. Today marks an important milestone for cancer care and reinforces the need for a paradigm shift in the way we approach this deadly disease. NantKwest and NantCell are actively working to initiate the clinical trial across investigational centers and we look forward to offering the NANT Cancer Vaccine regimen to pancreatic cancer patients.”
“Cancer cells often go undetected by the immune system; recently, it was found that cancer cells place a brake on the immune system by checkpoint receptors. This discovery has brought forth a new revolution of immuno-oncology with the launch of multiple checkpoint inhibitors. We realize, however, that checkpoint inhibition alone is insufficient to fully activate the immune system to combat the cancerous tumor,” stated Leonard S. Sender, M.D., Senior Vice President of Medical Affairs for Pediatric, Adolescent and Young Adult Oncology at NantKwest. “NANT Cancer Vaccine is a unique, multi-agent protocol aimed at orchestrating all the components of the immune system needed to combat cancer.”
Cautionary Note Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning or implying the timing and conduct of our clinical studies, the anticipated safety and efficacy of our NK cell therapy and the accomplishment and timing of related regulatory determinations and filings. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties include, but are not limited to, the rate of subject enrollment in our clinical studies; the number of subjects that will need to be enrolled in the trial; difficulty obtaining and maintaining regulatory approvals; our limited experience in conducting clinical studies and significant issues regarding our clinical studies, including, but not limited to, the successful opening and the continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, unexpected adverse events or safety issues and the sufficiency of funding and adverse events affecting our ability to manufacture and supply cell therapy for our clinical studies. There can be no assurance that data from any of our clinical studies will be sufficient to support an application for marketing in any country or that any such application will ever be approved. These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016. These forward-looking statements speak only as of the date hereof, and NantKwest, Inc. disclaims any obligation to update these statements except as may be required by law.
About NANT Cancer Vaccine
The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low dose radiation and chemotherapy with molecularly informed tumor associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.
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) Chimeric Antigen Receptor (CAR) activated killing using taNKs, which are NK cells engineered to incorporate CARs to target tumor-specific antigens found on the surface of cancer cells.
Our aNK, haNK® and taNK TM 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 http://www.nantkwest.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.
NantCell, a wholly-owned subsidiary of NantWorks, LLC, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient's tumor, independent of the cancer's anatomical type.
NantCell's mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive “omic” analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive “omic” analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. Through these integrated diagnostic methods, the company is pursuing the vision of treating the biology of cancer rather than the anatomy, and driving the immune system inherited by all to defeat cancer. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.
About NantHealth, Inc.
NantHealth, Inc., a member of the NantWorks ecosystem of companies, is a next-generation, evidence-based, personalized healthcare company enabling improved patient outcomes and more effective treatment decisions for critical illnesses. NantHealth's unique systems-based approach to personalized healthcare applies novel diagnostics tailored to the specific molecular profiles of patient tissues and integrates this molecular data in a clinical setting with large-scale, real-time biometric signal and phenotypic data to track patient outcomes and deliver precision medicine. For nearly a decade, NantHealth has developed an adaptive learning system, which includes its unique software, middleware and hardware systems infrastructure that collects, indexes, analyzes and interprets billions of molecular, clinical, operational and financial data points derived from novel and traditional sources, continuously improves decision-making and further optimizes our clinical pathways and decision algorithms over time. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.