Completion of Phase
1 First-in-Human Trials of Cryopreserved, Off-The-Shelf
haNK Cells Leads the Way to Pivotal Phase 2
Trials in Relapsed Merkel Cell Carcinoma
Funding to Support INDs for
First-in-Human Targeted Off-The-Shelf NK Cells
(t-haNKs) with PD-L1 and CD-19 as Tumor Targets
NantKwest (Nasdaq:NK), a leading clinical-stage, natural
killer cell based therapeutics company, today announced that
Patrick Soon-Shiong, MD, the company’s Chairman & CEO, on March
21, 2019, exercised 17,589,250 warrants with an exercise price of
$1.9984 and 1,851,000 options with an exercise price of $2.1983,
representing an aggregate cash exercise price of $39.2.
In commenting on the exercise of the warrants and options, Dr.
Soon-Shiong said the following: “Since the launch of NantKwest in
2015, the company has made remarkable progress in the development
of a true, 'off-the-shelf' and 'ready-to-use' Natural Killer (NK)
cell therapy that could be shipped on an 'as needed basis,' just
about anywhere in the world. We have successfully established a
truly off-the-shelf, cryopreserved product and are now ready to
embark on pivotal trials. This advanced manufacturing capability
combined with our ability to develop NK cells with high killing
activity provides us with a distinct advantage as the leading
company developing an immediately available NK cell therapy for
patients with cancer.”
Dr. Soon-Shiong continued, “My commitment and
confidence in the future success of NantKwest has never been
stronger. I firmly believe that the natural killer cell represents
the missing link in our war against cancer. I believe that only by
orchestrating the activity of the natural killer cell, the innate
immune system, as well as the killer T cell, the adaptive immune
system, could we achieve long lasting responses to
immunotherapy. NantKwest represents this next
generation of cell therapy with the potential
to achieve activation of the memory T and
NK cell, the holy grail of immunotherapy. Contributing an
additional $39.2 million to the financial resources of NantKwest
will enable the rapid opening of multiple clinical trial sites for
the Phase 2 trial of off-the-shelf activated natural killer cells
(haNK cells), combined with an IL-15 cytokine (N-803) which may
proliferate NK and T cells, to treat refractory patients suffering
from a deadly disease, Merkel Cell Carcinoma. In addition,
preclinical data of the world’s first targeted off-the-shelf haNK
cells (t-haNK) are highly encouraging and we are
planning the first in human trials of both
PD-L1 t-haNK and CD-19 t-haNK
(targeted-haNKs) this year.”
Dr. Soon-Shiong provided an update on the haNK and
t-haNK programs at his keynote address to the scientific
community at "The Innate Killer Summit" in San
Diego on March 20, 2019.
For more information on 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/20190325005242/en/
Jen Hodson562-397-3639jhodson@nantworks.com
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