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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version on businesswire.com: http://www.businesswire.com/news/home/20170509005590/en/
NantWorksJen Hodson, 562-397-3639jhodson@nantworks.com
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