Landmark First-In-Human Clinical Study Launch Using a Genetically Engineered Natural Killer Cell for the Treatment of Cancer
January 23 2017 - 12:47PM
Business Wire
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, infectious diseases, and inflammatory diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has authorized the company’s Investigational New Drug Application
(IND) for its first-in-human, high-affinity natural killer (haNK)
cell therapy Phase I clinical study.
The company plans to promptly initiate this trial, which is
believed to be the first ever clinical evaluation of a genetically
engineered, allogenic, off-the-shelf, natural killer cell for the
treatment of patients with cancer.
“We are thrilled to have received notification from the FDA that
our first haNK cell therapy program has been authorized to proceed
into Phase I clinical trials and are focused on moving swiftly to
begin this study,” said Patrick Soon-Shiong, MD, Chairman and CEO
of NantKwest. “The FDA’s authorization to initiate this clinical
trial achieves a significant milestone for NantKwest as we begin
clinical investigation of the use of haNK cell therapy for the
treatment of cancer in a wide range of cancer types.”
haNK Cell Therapy Platform
NantKwest’s haNK cell therapy platform, developed to be an
allogeneic, off-the-shelf therapy, is focused on optimizing the key
role that natural killer cells play in mediating innate immunity,
enhancing adaptive immune responses, and, specifically in the case
of haNK, improving anti-tumor responses via antibody-dependent
cell-mediated cytotoxicity (ADCC).
To achieve this objective, haNK cells have been engineered to
express IL-2 and the high-affinity variant of the CD16 receptor
(V158 FcγRIIIa). In preclinical studies, the addition of haNK to a
variety of therapeutic antibodies has led to increased tumor cell
killing when compared to the antibody alone. Thus, this
first-in-human clinical study is designed to provide the necessary
safety data to rapidly transition to haNK-antibody combination
trials.
Dr. Soon-Shiong added, “As only about 10% of patients are born
with the high affinity CD16 receptor, we believe the potential for
haNK cell therapy to improve patient outcomes for the other 90% of
the patient population and become part of the standard-of-care for
cancer patients is very compelling.”
Study Background
The primary objective of the study is to determine the safety of
haNK cell monotherapy administered intravenously once per week in
up to 16 patients with metastatic or locally advanced solid tumors.
Other objectives include 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, Public Relations DirectorCell:
562-397-3639jhodson@nantworks.com
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