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.
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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.
About NantBioScience
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.
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