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 cancer cells.
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 Biologics.
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.
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 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 forward-looking statements.
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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version on businesswire.com: https://www.businesswire.com/news/home/20190401005291/en/
Jen Hodson562-397-3639jhodson@nantworks.com
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