First engineered, GMP-grade, cryopreserved,
off-the-shelf, bi-specific NK cell therapy to enter human clinical
trials targeting CD16 and CD19 in patients with lymphoma
NantKwest Inc. (Nasdaq:NK), 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 other diseases, today
announced that the company’s t-haNK investigational new drug
application (IND) has cleared FDA review and the program has now
transitioned to a first-in-human clinical trial targeting CD19
t-haNK in advanced B-cell lymphoma.
CD19 is a transmembrane protein expressed in B cells and
overexpressed in a large percentage of advanced leukemia and
lymphoma representing a well validated therapeutic target. The CD19
t-haNK cell therapy is a novel, NK cell based immuno-oncology
therapy that includes a CD19-based Chimeric Antigen Receptor (CAR)
that has been engineered to create an NK cell that includes the
high affinity CD16 (Fc receptor), which enhances an NK cell’s
ability to bind and enhance monoclonal antibody activity. Use of a
targeted, bi-specific NK cell is intended to enhance the cancer
cell killing ability of this novel NK cell therapy.
“Based on extensive and encouraging preclinical results, we have
enhanced our ability to modularly combine this proprietary
off-the-shelf t-haNK-based therapy with a wide range of monoclonal
antibodies using this multi-targeted approach,” commented Dr.
Patrick Soon-Shiong, Chairman and CEO of NantKwest. Dr. Soon-Shiong
continued, “We are now ready to transition this innovation in NK
cell based therapeutics to a Phase I human clinical
trials designed to assess the safety, tolerability and
efficacy of CD19 t-haNK cell therapy in advanced b-cell
lymphoma. Upon completion of the safety phase, NantKwest intends to
combine this CD19 t-haNK cell therapy with other synergistic,
immunomodulatory agents as part of an integrative, combination
therapy approach that we describe as the NANT Cancer Vaccine to
further enhance the synergistic effectiveness of this novel
therapeutic intervention.”
CD19 t-haNK
NantKwest’s CD19-t-haNK cell therapy is designed to provide
precise tumor-cell specificity through the use of a CAR construct
that utilizes a CD19-specific scFv (single chain antibody fragment)
engineered into the company’s proprietary NK cell that includes the
CD16 (Fc high affinity receptor).
In pre-clinical studies, cytotoxicity of these GMP-grade,
cryopreserved CD19 t-haNK cells were comprehensively evaluated
against a panel of cancer cell lines with different levels of CD19
expression in vitro and in vivo, with these studies showing
increased activity and selective cytotoxicity towards
CD19-expressing tumor cells of various b-cell origins including
leukemia.
To better inform routine patient care, these clinical trials
will incorporate a state-of-the-art, biomarker analysis using GPS
Cancer™, which is an integrated, multi-omics, whole genome,
transcriptomic platform, both provided by NantHealth, an affiliated
company. These comprehensive molecular analysis tools are designed
to provide critical information to the clinical study team
regarding the unique molecular alterations associated with the
patient’s cancer and response rates, potentially enhancing patient
management.
Additional information regarding the CD19 t-haNK clinical study
can be found at www.nantkwest.com
or www.clinicaltrials.gov/.
About NantKwest
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 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 500 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 that NantKwest 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
NantKwest’s 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 NantKwest’s business are
described in detail in its Securities and Exchange Commission
filings, including in NantKwest’s Quarterly Report on Form 10-Q for
the quarter ended March 31, 2019. 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/20190603005734/en/
Media Contact:Jen Hodson562-397-3639Jen@nant.com
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