NANTKWEST, INC. (NASDAQ:NK)
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6 Months : From Jan 2019 to Jul 2019
New haNK and T-haNK Based Natural Killer Cell Therapy Programs to
Transition to Human Clinical Trials in 2019
NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell
based therapeutics company, today announced that the Company has been
issued a new patent that further expands the Company’s foundational
natural killer cell-therapeutics platform intellectual property estate.
This new patent builds upon NantKwest’s extensive existing patent estate
and broadens the Company’s established intellectual property combining
haNK natural killer cell therapy together with antibody therapy.
This novel engineered haNK cell product represents the core foundational
element of the Company’s haNK therapeutics program.
The patent, EP2801583, issued by the European Patent Office,
“Genetically Modified Human Natural Killer Cell,” includes a key
composition claim directed to NantKwest’s proprietary haNK cells that
have been engineered to express a high affinity Fc receptor (FcyRlll-A),
also described as CD16, in combination with an antibody that
specifically binds to an antigen expressed by a cancer or infected cell.
The engineering of CD16 into an aNK cell forms the basis of a haNK
natural killer cell and cements the ability of haNK cells to mediate
antibody dependent cellular cytotoxicity (ADCC). ADCC is an important
and highly desirable therapeutic capability, as the therapeutic
effectiveness of five of the most widely used antibody drugs in clinical
use have shown dependence on ADCC which can be potentially enhanced when
used in combination with the Company’s haNK cell therapy. These five
antibody therapies include: Avelumab, targeting the PD-L1 checkpoint in
solid tumors; cetuximab, targeting EGFR in solid tumors; rituximab,
targeting CD20 in hematological malignancies; and trastuzumab and
pertuzumab targeting HER2 in breast cancer.
Having completed initial human clinical safety testing and safely
administering over 300 infusions as a cryopreserved, “off-the-shelf”
ready-to-use therapy, clinical programs that incorporate haNK cell
therapy including our Merkel cell carcinoma trial, recently authorized
by the FDA, which is a novel combination study that incorporates three
synergistic therapeutic agents consisting of (1) avelumab, an antibody
therapy targeting PD-L1 that is a well validated therapeutic target,
expressed in a large percentage of cancer cells; (2) N-803, a novel,
superagonist, IL-15 cytokine-based immune stimulating agent that the
Company has co-exclusive worldwide rights to under the terms of a
co-development agreement; and (3) haNK natural killer cells, which are
intended to enhance the existing cancer cell killing activities of
avelumab, while also contributing to the direct cancer cell killing
effects of haNK natural killer cell therapy. These three agents are
intended to synergistically enhance the targeting and elimination of
In addition, currently in advanced development utilizing the haNK
technology platform include two clinical candidates transitioning from
the Company’s t-haNK program. A t-haNK is a haNK natural killer cell
additionally engineered to include an antigen-targeting, single chain
antibody fragment (sc-Fv). These two t-haNK clinical candidates include
a PD-L1 t-haNK therapy targeting solid tumors such as lung cancers and a
CD19 t-haNK therapy targeting hematological malignancies. Both of these
programs are anticipated to transition to human clinical trials in 2019.
Commenting on this landmark patent award, Dr. Patrick Soon-Shiong,
Chairman and CEO of NantKwest stated, “We are pleased to announce the
issuance of this important new patent covering our haNK natural killer
cell technology platform in the European Union, further expanding our
worldwide natural killer cell therapy intellectual patent estate. We
continue to focus on enhancing our intellectual property rights
associated with the Company’s natural killer cell based therapeutics
platform while also seeking to innovate in order to maintain and expand
our strong proprietary position in the field of NK cell based
immunotherapies. Our haNK cell therapy program represents a core
foundational program and we are committed to bringing this innovation in
next generation cell therapy to cancer patients as rapidly as possible.”
In addition to clinical applications of our haNK and t-haNK cell
products, this newly issued patent furthers NantKwest’s exclusive rights
for the use of these CD16 expressing haNK cells in ADCC based laboratory
testing of monoclonal antibodies that are intended for commercial
applications. These cells are made available for non-clinical
applications through its affiliate and exclusive licensee, Brink
For more information regarding NantKwest, please visit www.nantkwest.com.
About NantKwest Inc.
NantKwest, a member of the NantWorks ecosystem of companies, is an
innovative clinical-stage immunotherapy company focused on harnessing
the power of the innate immune system by using the natural killer cell
to treat cancer and virally induced infectious diseases.
NantKwest is uniquely positioned to implement precision cancer medicine,
with the potential to change the current paradigm of cancer care.
Natural Killer (NK) cells are a safeguard in the human body designed to
recognize and detect cells under stress due to cancer or viral
infection. NantKwest’s “off-the-shelf” activated NK cell platform is
designed to destroy cancer and virally infected cells from the body. The
safety of our NK cells as well as their activity against a broad range
of cancers have been tested in phase I clinical trials in Canada and
Europe as well as in multiple phase I and II clinical trials in the
United States. In addition to being a universal cell-based therapy that
does not require individualized patient sourcing or matching, our NK
cell products have been largely administered in the outpatient setting
as an “off-the-shelf” living drug.
With the capacity to grow active killer cells as a living cancer
therapy, our NK cells have been designed to induce cell death against
cancers and virally infected cells by several mechanisms, including: (i)
innate killing, whereby all of our NK platforms recognize the stress
proteins typically found on cancer cells, which, upon binding, release
toxic granules to immediately kill their targets; (ii) antibody-mediated
killing with our haNK® platform, which are NK cells engineered to
express antibody receptors that can bind to therapeutic antibody
products, thereby enhancing the cancer cell killing effect of that
antibody; and (iii) Chimeric Antigen Receptor directed killing using the
taNK® platform, which includes NK cells engineered to incorporate
chimeric antigen receptors (CARs) to target tumor-specific antigens
found on the surface of cancer cells. All three modes of killing
(innate, antibody-mediated, and CAR directed killing) are employed by
our t-haNK™ platform, which is an innovative combination of our aNK,
haNK® and taNK® platforms in a single product.
Our haNK®, and t-haNK™ platforms have been designed to address certain
limitations of CAR T-cell therapy including the capability to infuse
cell therapy in an outpatient setting which allows for potential
reduction of risk for serious cytokine storms and protracted serious
adverse events. In Phase I and II clinical trials in patients with late
stage cancer, our NK cells have been administered as an investigational
outpatient infusion safely with greater than 300 infusions to date at a
dose of 2 billion cells per infusion.
By leveraging an integrated and extensive genomics and transcriptomics
discovery and development engine, together with a pipeline of multiple,
clinical-stage, immuno-oncology programs, 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.
NK-92, aNK, haNK, taNK, and t-haNK are trademarks of NantKwest, Inc.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include statements concerning or implying the
Company will be successful in improving the treatment of cancer. Risks
and uncertainties related to this endeavor include, but are not limited
to, obtaining FDA approval of our NK cells as well as other therapeutics
as part of the NANT Cancer Vaccine platform as a cancer treatment.
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
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 year ended December 31, 2018. These
forward-looking statements speak only as of the date hereof, and we
disclaim any obligation to update these statements except as may be
required by law.
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