First engineered, GMP-grade, cryopreserved,
off-the-shelf, bi-specific NK cell therapy to enter human clinical
trials targeting PD-L1 and CD16 in patients with solid
tumors
NantKwest establishes a leading portfolio of
off-the-shelf NK cells at clinical stage of development with three
engineered NK92 cells in trials: CD16 targeted haNK, CD19/CD16
targeted t-haNK and now PD-L1/CD16 targeted t-haNK
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 PD-L1 t-haNK investigational new drug
application (IND) has cleared FDA review and the program has now
transitioned to a first-in-human clinical trial in patients with
locally advanced or metastatic solid cancers.
Programmed death-ligand 1 (PD-L1) is a transmembrane protein
that plays a major role in suppressing the immune system in many
cancer patients. The binding of PD-L1 to the inhibitory checkpoint
molecule PD-1 establishes an inhibitory signal that reduces the
proliferation of antigen-specific T-cells while also reducing
apoptosis in suppressive regulatory T cells (Tregs) that further
inhibits immune responses.
NantKwest’s PD-L1 t-haNK cell therapy is a novel, NK cell-based
immuno-oncology therapy that includes a PD-L1 based Chimeric
Antigen Receptor (CAR) engineered into the company’s proprietary
haNK NK cell, which also includes the high affinity variant of the
CD16 receptor (V158 FcγRIIIa) to mediate antibody dependent
cellular cytotoxicity (ADCC). Together, the use of this targeted,
bi-specific, next generation PD-L1 t-haNK therapy has been shown in
preclinical studies to significantly enhance cancer cell killing
and improve overall response rates.
“In just a few short weeks since announcing the FDA clearance of
our first bi-specific, engineered NK cell therapy clinical trial
using a CD19 t-haNK targeting patients in lymphoma, we are now
pleased to announce that the FDA has authorized the company to go
forward with our second bi-specific NK cell therapy clinical trial
using a PD-L1 t-haNK targeting patients with solid tumors,”
commented Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest.
Dr. Soon-Shiong continued, “We plan to synergistically combine a
wide range of immunotherapy molecules with our proprietary,
multi-targeted, off-the-shelf NK cell therapy, in this case, a
PD-L1 t-haNK to explore the unique therapeutic potential of
integrating both the innate and adaptive immune systems to achieve
durable complete remissions. Based on the FDA clearance, we look to
rapidly transition this program to a Phase I human clinical trial
designed to assess the safety, tolerability and efficacy of PD-L1
t-haNK cell therapy in patients with solid tumors. Upon completion
of this safety phase, NantKwest intends to combine this PD-L1
t-haNK cell therapy with other immunomodulatory agents including
NabFc-N803, a IL15 cytokine super agonist and Adenovirus/ yeast
vectors delivering tumor associated and neoantigens, as part of an
integrative, combination therapy designed to further enhance the
therapeutic effectiveness of this novel NK cell-based therapeutic
intervention, which we describe as our NANT Cancer Memory
Vaccine.”
PD-L1 t-haNK
NantKwest’s PD-L1 t-haNK cell therapy is designed to provide
precise tumor-cell specificity through the use of a CAR construct
that utilizes a PD-L1-specific scFv (single chain antibody
fragment) engineered into the company’s proprietary haNK NK cell
that includes the high affinity variant of the CD16 receptor (V158
FcγRIIIa) to mediate antibody dependent cellular cytotoxicity
(ADCC). In preclinical studies, cytotoxicity of these GMP-grade,
cryopreserved PD-L1 t-haNK cells were comprehensively evaluated
against a panel of cancer cell lines with different levels of PD-L1
expression in vitro and in vivo, with these studies showing
increased activity and selective cytotoxicity toward a wide range
of PD-L1-expressing tumor cells.
To better inform routine patient care, these clinical trials
will incorporate a state-of-the-art, biomarker analysis, including
GPS Cancer™, which is an integrated, multi-omics, whole genome,
transcriptomic platform, 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 PD-L1 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/20190624005204/en/
Jen Hodson 562-397-3639 Jen@nant.com
NantKwest (NASDAQ:NK)
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