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
CULVER CITY, Calif.–(BUSINESS WIRE)–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.
Contacts
Jen Hodson
562-397-3639
jhodson@nantworks.com