NantKwest and NantCell Announce FDA Authorization for the NANT Cancer Vaccine Clinical Trials, the First
Novel Combination of Innate and Adaptive Immunotherapy in Patients with Pancreatic Cancer
The NANT Cancer Vaccine, the First Simultaneous Combination of Off the Shelf Natural Killer Cells (NK) With
Endogenous Adaptive Dendritic, T Cell and NK Cell Activation
Personalized Molecular Informed Therapy with NantHealth's GPS Cancer as the Complementary Diagnostic for All
Tumor Types
A Cancer Breakthroughs 2020 Milestone to Address Multiple Cancer Types at All Stages of
Disease
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.
About NantKwest
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.
About NantCell
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.
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NantWorks
Jen Hodson, 562-397-3639
jhodson@nantworks.com
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