NantKwest Announces FDA Grant of Orphan Drug Designation for the Company’s aNK Natural Killer Cell Therapy in Merkel Cell C...
March 20 2017 - 7:00AM
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 inflammatory diseases,
announced today that the FDA has granted Orphan Drug Designation to
the company’s activated natural killer (aNK) cell therapy for
treatment of patients with advanced Merkel cell carcinoma.
NantKwest’s aNK cell therapy is currently in Phase II clinical
trials at clinical sites in the United States treating subjects
with metastatic or locally advanced Merkel cell carcinoma. This
protocol was recently amended to include ALT-803, an IL-15
superagonist therapy that has been shown in preclinical clinical
studies to improve the activity of NK cells and will
synergistically improve the activity of both NantKwest’s infused
aNK cells together with the subject’s own NK cells. The Phase
II clinical trial will continue based on this novel drug
combination.
The application for Orphan Drug Designation was based in part on
data presented at the Annual Society of Immunotherapy (SITC)
meeting in November 2016. At the SITC meeting, Dr. Shailender
Bhatia from the University of Washington, Fred Hutchinson Cancer
Research Center in Seattle, WA presented interim data showing that
in a heavily pretreated patient population, many previously having
been treated with a number of other therapies including checkpoint
inhibitors, aNK natural killer cell therapy demonstrated activity
in patients who failed multiple lines of therapy including check
point inhibitors.
In commenting on the FDA’s grant of Orphan Drug Designation, Dr.
Patrick Soon-Shiong, Chairman and CEO of NantKwest, said: “We
believe the FDA’s award of Orphan Drug Designation together with
additional data coming out of our ongoing Merkel cell carcinoma
Phase II clinical trial will provide us a solid position to submit
to the FDA our plans to transition this study to a pivotal
study.”
Dr. Soon-Shiong added, “Patients with metastatic or locally
advanced Merkel cell carcinoma have an extremely poor prognosis,
with less than 20% of patients surviving longer than five years. We
are encouraged to see, even in a heavily pretreated patient
population, that our aNK natural killer cell therapy has been shown
to exhibit encouraging antitumor activity and we look forward to
the rapid development of this clinical program as we strive to
bring the potential for long-term, durable responses to a broad
range of cancer patients in multiple cancer indications."
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, among others, statements
concerning or implying the timing and conduct of our clinical
studies, the anticipated safety and efficacy of our aNK cell
therapy and the accomplishment and timing of related
regulatory determinations and filings. 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. Risks and uncertainties include, but
are not limited to, the rate of subject enrollment in our clinical
studies; the number of subjects that will need to be enrolled in
the trial; difficulty obtaining and maintaining regulatory
approvals; our limited experience in conducting clinical studies
and significant issues regarding our clinical studies, including,
but not limited to, the successful opening and the continued
participation of clinical sites and their ongoing adherence to
protocols, assumptions regarding enrollment rates, timing and
availability of subjects meeting inclusion and exclusion criteria,
changes to protocols or regulatory requirements, the ability to
comply with and meet applicable laws and regulations, unexpected
adverse events or safety issues and the sufficiency of funding and
adverse events effecting our ability manufacture and supply cell
therapy for our clinical studies. There can be no assurance that
data from any of our clinical studies will be sufficient to support
an application for marketing in any country or that any such
application will ever be approved. These and other risks regarding
our business are described in detail in our Securities and Exchange
Commission filings, including in our Quarterly Report on Form 10-K
for the fiscal year ended December 31, 2016. These forward-looking
statements speak only as of the date hereof, and NantKwest, Inc.
disclaims any obligation to update these statements except as may
be required by law.
About NantKwest
NantKwest (Nasdaq:NK) is 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 inflammatory diseases. NK
cells are the body’s first line of defense due to the innate
ability of NK cells to rapidly identify and destroy cells under
stress, such as cancer or virally-infected cells.
NantKwest’s unique NK cell-based platform, with the capacity to
grow active killer cells as a biological cancer therapy, has been
designed to induce cell death against cancer or infected cells by
three different modes of action: (1) Direct killing using activated
NK cells (aNK) that release toxic granules directly into the cell
through cell-to-cell contact, (2) Antibody-mediated killing using
haNKs, which are NK cells engineered to incorporate a high affinity
receptor that binds to an administered antibody, enhancing the
cancer cell killing effect of that antibody, and (3) Targeted
activated killing using taNKs, which are NK cells engineered to
incorporate chimeric antigen receptors (CARs) to target
tumor-specific antigens found on the surface of cancer cells.
Our aNK, haNK and taNK platform addresses certain limitations of
T cell therapies, including the reduction of risk of serious
"cytokine storms" reported after T cell therapy. As an
“off-the-shelf” therapy, NantKwest's NK cells do not rely on a
patient’s own often compromised immune system. In Phase I clinical
trials in patients with late stage cancer, NantKwest's NK cells
have been successfully administered as an outpatient infusion
therapy without any reported severe side effects, even at doses of
10 billion cells.
By leveraging an integrated and extensive genomics and
transcriptomics discovery and development engine, together with a
pipeline of multiple, clinical-stage, immuno-oncology programs that
include a Phase II trial for a rare form of melanoma and the
planned initiation of a clinical trial of NK cells targeted to
breast cancer, 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. For more
information please visit http://www.nantkwest.com and
follow Dr. Soon-Shiong on Twitter@Dr.PatSoonShiong.
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NantWorksJen Hodson, 562-397-3639jhodson@nantworks.com
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