First Combination Off The Shelf NK And Adaptive Immunotherapy Trial To Be Initiated For Pancreatic, Lung, Breast, Colon, Melanoma, Sarcoma, Chordoma, Head And Neck, Non Hodgkin’s Lymphoma, Merkel Cell And Ovarian Cancers.
First Whole Genome, Transcriptomic, Proteomic (GPS Cancer) Informed Immunotherapy Trials Across All Tumor Types
Culver City, CA – June 6, 2017 – NantKwest and Nantworks today announced at the 2017 Annual American Society for Clinical Oncology meeting (ASCO) in Chicago, IL the expansion of the company’s existing NANT Cancer Vaccine program in pancreatic cancer (ClinicalTrials.gov NCT03136406) to target a number of additional tumor types.
The NANT Cancer Vaccine program is a personalized, molecularly-informed therapy guided by NantHealth’s GPS Cancer test that includes the simultaneous combination of off the shelf natural killer cells (NK) with the endogenous activation of dendritic, T cell and NK cells to more fully enhance the innate and adaptive immune system of cancer patients.
The NANT Cancer Vaccine is the first combination immunotherapy protocol formulated to include the novel delivery of metronomic, low-dose chemotherapy and radiation with molecularly-informed, tumor-associated antigen vaccines, together with NantKwest’s NK cell therapy, to induce immunogenic cell death while avoiding the ravages of toxic high dose chemotherapy.
By inducing immunogenic cell death and enhancing a patient’s innate and adaptive immune system, the NANT Cancer Vaccine is designed to attain a long-term, durable response in multiple cancer types with lower toxicity and higher efficacy in comparison with current standards of care.
“Current therapeutic approaches to the treatment of cancer are often inadequate to fully activate a patient’s immune response. Through the NANT Cancer Vaccine program, we believe we can help facilitate a paradigm shift in cancer care with the first clinical program formulated to incorporate low dose, metronomic chemotherapy and radiation, combined with molecularly-informed tumor associated antigens that are designed to activate dendritic and T cells by adenoviral and yeast vaccine vectors, together with both endogenous (IL-15) and exogenous (off the shelf) activation of NantKwest’s NK cell therapy,” said Patrick Soon-Shiong, Chairman and CEO of NantKwest.
Dr. Soon-Shiong continued, “In addition to the previously announced Pancreatic Cancer Vaccine, we are now actively working to initiate multiple clinical trials across a wide range of cancer types which include: Lung, breast, head and neck cancer, colon, melanoma, ovarian, urothelial, Hodgkins and non-Hodgkins lymphoma, sarcoma, and Merkel cell carcinoma, all based on a similar treatment protocol and designed to more fully harness the power of the immune system and improve cancer patient outcomes.”
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 effecting our ability 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.
About NantKwest Inc.
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
About GPS Cancer
GPS Cancer™ is a comprehensive molecular profile available through NantHealth. GPS Cancer integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, providing oncologists with unprecedented insight into the molecular signature of each patient’s cancer to inform personalized treatment strategies. GPS Cancer profiling is conducted in CLIA-certified and CAP-accredited laboratories, and is a key enabler for the QUILT programs. GPS Cancer is a unique and comprehensive test available on the market today; this is the first test that has transcended beyond the genome and crossed to the proteome. For more information, visit www.gpscancer.com
NantWorks, LLC, is the umbrella organization for an ecosystem of companies committed to the convergence of 21st century innovative platforms to transform how we work, live and play: NantHealth, NantOmics, NantBioScience, NantCell and its affiliate NantKwest, NantPharma, NantMobile, NantStudio, NantCapital and NantCloud. Fact-based and solution driven, each of NantWorks’ division companies operates at the intersection of innovation and infrastructure.
Founded by Dr. Patrick Soon-Shiong, scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane, the core mission for NantWorks is convergence: to develop and deliver a diverse range of technologies that accelerate innovation, broaden the scope of scientific discovery, enhance ground-breaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically-informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics. For more information please visit NantWorks.com and NantHealth.com and follow Dr. Soon-Shiong on Twitter @Dr.PatSoonShiong