NantKwest Doses First Patient in Phase 2 Single-Arm Trial of Metastatic Merkel Cell Carcinoma Therapy With Off-the-Shelf CD16...
March 19 2020 - 7:00AM
Business Wire
Clinical trial for patients failing checkpoint
therapy uses combination of first-in-class, cryopreserved, CD16 NK
cells, ImmunityBio’s IL-15 superagonist and checkpoint inhibitor
Avelumab
NantKwest, Inc. (Nasdaq: NK), a next-generation, clinical-stage
immunotherapy company focused on harnessing the unique power of our
immune system using natural killer (NK) cells to treat cancer and
infectious diseases, today announced dosing of the first patient in
a Phase 2 trial for second- and third-line Merkel cell carcinoma
(MCC) in patients who are refractory to immune checkpoint
inhibitors. The trial will evaluate the Company’s first-in-class,
off-the-shelf CD16-targeted natural killer (haNK) cells in
combination with ImmunityBio’s IL-15 superagonist N-803 and
Avelumab.
MCC is a rare and aggressive skin cancer that arises from
uncontrolled growth of cells in the skin. Increasing in incidence,
approximately 2,500 new cases are reported in the U.S. each year.
Patients with metastatic or locally advanced MCC have an extremely
poor prognosis, with less than 20% of patients surviving longer
than five years. Typically, these patients are treated with a range
of drugs, including chemotherapy, which can result in significant
side effects. Although new immune therapies have the potential to
improve survival, Merkel cell carcinoma is still fatal for a
majority of patients who have progressed on or after treatment with
a checkpoint inhibitor and represents an unmet medical need.
“With over 70% of patients failing checkpoint inhibitors in
solid tumors, it is vital to develop novel and effective
therapeutic options,” said Patrick Soon-Shiong, M.D., chairman and
CEO of NantKwest and ImmunityBio. “Checkpoint and CAR-T therapies
only target the T cell, which is a small portion of effector killer
cells, and often result in substantial side effects. These side
effects make those therapies unusable for many patients. Our
combination therapy is designed to activate the innate immune
system to create an immunological memory against tumors, resulting
in immunogenic cell death.”
“We have now established the first-in-class, cryopreserved CD16
NK-92 cell line, which can be manufactured under GMP conditions at
scale. Having accomplished this development and manufacturing
milestone in the field of NK cell therapy, we are actively pursuing
pivotal trials for our CD16 NK-92 products haNK and PD-L1 t-haNK,”
continued Soon-Shiong.
The single-arm study will involve 43 patients who failed all
standard of care treatments for MCC, including checkpoint therapy
(QUILT-3.063; NCT03853317). Clinical trial sites are currently
being activated.
“Single-arm studies allow us to offer patients who have no other
approved treatment options the opportunity to participate in a
potential treatment for this rare and deadly disease without fear
of receiving a placebo drug,” said John Lee, M.D., senior vice
president of adult medical affairs at NantKwest. “Our past study
using our non-targeted aNK cells showed clinical responses either
alone or in combination with N-803. The current study builds on
this approach using a PD-L1 antibody that will bind to the high
affinity CD16 receptor on haNK cells to potentially help target
PD-L1 tumor cells. The N-803 superagonist has been shown to enhance
the body’s NK and T cells to also help attack the tumor cells. The
goal of this work is to provide real hope for these patients using
the power of our combination therapies.”
About NantKwest
NantKwest (NASDAQ: NK) is an innovative, clinical-stage
immunotherapy company focused on harnessing the power of the innate
immune system to treat cancer and virally induced infectious
diseases. NantKwest is the leading producer of clinical dose forms
of off-the-shelf Natural Killer (NK) cell therapies. The activated
NK cell platform is designed to destroy cancer and virally infected
cells from the body. The safety of NantKwest’s optimized, activated
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. By leveraging an integrated and extensive
genomics and transcriptomics discovery and development engine,
together with a pipeline of multiple, clinical-stage,
immuno-oncology programs, NantKwest’s goal is to transform medicine
by delivering living drugs in a bag and bringing novel NK
cell-based therapies to routine clinical care. NantKwest is a
member of the NantWorks ecosystem of companies. For more
information, please visit www.nantkwest.com.
haNK is a registered trademark 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 September 30, 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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Jen Hodson Jen@nant.com
NantKwest (NASDAQ:NK)
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