NantKwest Announces Successful First in Human Administration of CD16 High Affinity Natural Killer (haNK) Cells
October 02 2017 - 8:00AM
Business Wire
Successful Administration Of Off The Shelf
Hank Cells In Patients With Solid Tumors Paves The Way To
Nation's First Combination Innate And Adaptive NANT Cancer Vaccine
Trials In Multiple Tumor Types
NantKwest Inc. (Nasdaq:NK), a pioneering, next-generation,
clinical-stage immunotherapy company focused on harnessing the
unique power of the immune system using natural killer (NK) cells
to treat cancer today announced the clinical implementation of
the company’s haNK cell therapy program to human clinical trials
with the first participants treated in the first-in-human, Phase I
haNK cell therapy clinical trial targeting a wide range of cancer
types.
"Only about 10% of individuals are born with a high affinity
Natural Killer cell type needed for the maximum killing effect when
combined with monoclonal antibodies widely used in clinical
practice today such as Trastuzamab, Rituxan and Avulamab. To
maximize tumor cell death by this mechanism known as ADCC we have
engineered our off the shelf natural killer cell line with a
high affinity CD16 receptor. The potential for this haNK cell
therapy is to improve patient outcomes for a significant percentage
of the other 90% of individuals being treated with antibody therapy
in a broad range of tumor types that can now be explored," said
Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest.
Dr. Soon-Shiong added, “Our haNK cell therapy program was
designed to optimize the unique properties of two
immunotherapeutics (a cell based platform with a monoclonal
antibody) used as a combination therapy. Multiple published
preclinical studies have demonstrated the potential for
haNK/antibody combinations to synergistically enhance
antibody-dependent cell-mediated cytotoxicity (ADCC) activity,
providing a sound scientific rationale for the transition of the
haNK program into human clinical trials,” said Patrick Soon-Shiong,
MD, Chairman and CEO of NantKwest.
haNK Cell Therapy Platform
NantKwest’s haNK cell therapy platform, an allogeneic,
off-the-shelf therapy, was developed to optimize the key role of
natural killer cells in mediating innate immunity, enhancing
adaptive immune responses, and, specifically in the case of haNK,
improve anti-tumor responses via antibody-dependent cell-mediated
cytotoxicity (ADCC). ADCC is an important part of the human immune
system associated with the synergistic interaction of natural
killer cells with antibodies to directly kill a target cell that
has been identified by an antigen-specific antibody. ADCC
represents one of the key mechanisms that antibodies utilize to
target and kill cancer cells.
Engineered to express the high-affinity variant of the CD16,
high affinity Fc receptor (V158 FcγRIIIa), in multiple published
preclinical studies, the combination of haNK cells with a variety
of therapeutic antibodies has led to enhanced tumor cell killing
when compared to use of the antibody as a single therapeutic agent,
providing strong support for this novel combination
immunotherapeutic approach.
haNK Phase I Study Background
The primary objective of the Phase I clinical study is to
determine the safety of haNK cell therapy administered once per
week in up to 16 patients with metastatic or locally advanced solid
tumors. Secondary objectives include the determination of objective
response rate, progression-free survival, overall survival, and any
correlations between tumor molecular profiles (based on genomics,
transcriptomics, and quantitative proteomics) and patient
outcomes.
For additional information, including exclusion and inclusion
criteria, contact information and other details, please
visit www.clinicaltrials.gov, QUILT trial #3.028.
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 1 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 2 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 www.nantkwest.com.
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NantKwest Inc.Jen Hodson, 562-397-3639jhodson@nantworks.com
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