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
CULVER CITY, Calif.–(BUSINESS WIRE)–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.
Contacts
Media Contact:
Jen Hodson
562-397-3639
Jen@nant.com