Nantkwest and Frankfurt University Hospital Announce First in Human Dosing of off-the-Shelf HER2.taNK (Car–natural Kill...
13 2월 2018 - 10:00PM
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, today announced that
the first patient has been
dosed in a first-in-human, Phase
I clinical study in glioblastoma of
HER2.taNK, a novel, natural killer
cell-based immuno-oncology therapy using CAR
technology in patients. The
study is being led by Dr. Michael Burger,
principal investigator, together with co-principal
investigators Professor Joachim Steinbach, Head of the
Institute for Neuro-oncology at the Goethe University
Hospital, and Professor Christian Senft, Department of
Neurosurgery at the Goethe University Hospital in
Frankfurt/Main, Germany.
Natural killer cells are a critical component of the innate
immune system and the first line of defense against cancer
and viral infections. HER2.taNK is a natural killer
cell based therapeutic that has been engineered to
incorporate a novel Chimeric Antigen Receptor
(CAR) specific for the human epidermal growth factor
receptor 2 (HER2).
HER2 is overexpressed in a
large percentage of solid tumors,
including breast cancer and glioblastoma,
representing a well validated target.
The Phase I clinical study is designed to assess the
safety, tolerability and efficacy of intracranial injection
of HER2.taNK as a
single agent therapy in patients with recurrent
HER2-positive glioblastoma.
Glioblastoma is the most common and aggressive primary brain
tumor in adults and currently incurable. Present standard of care
includes surgical resection followed by radiotherapy and
chemotherapy. Despite this aggressive treatment, median survival
of glioblastoma patients is still only about 15 months,
and recurrence remains almost inevitable.
HER2.taNK
NantKwest’s HER2.taNK is designed to
provide precise tumor-cell specificity through the use of
a CAR construct that
employs a HER2-specific scFv antibody fragment
for cancer cell recognition and a human
CD28.CD3zeta signaling domain.
In pre-clinical studies, HER2.taNK specifically recognized
HER2-expressing cells of different tumor origins and displayed high
and selective antitumor activity in in vitro and in vivo
models (http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)30043-0). In
addition, HER2.taNK demonstrated selective cytotoxicity
against otherwise NK
cell resistant glioblastoma cell lines and primary
glioblastoma cultures. Antigen specificity and selective
cytotoxicity of HER2.taNK was retained in vivo,
resulting
in antitumoral activity in orthotopic human
glioblastoma xenograft models. In immunocompetent mice
carrying HER2-expressing murine glioblastoma
tumors, treatment with HER2.taNK induced an endogenous
antitumor immune response resulting in tumor rejection and
long-lasting resistance against tumor re-challenge at distant
sites
(https://academic.oup.com/jnci/article/108/5/djv375/2412457).
To better inform patient care, these
clinical trials will incorporate a
state-of-the-art, biomarker analysis using GPS Cancer™, an
integrated, multi-omics, whole genome, transcriptome and
proteomics molecular analysis provided by
NantHealth, an affiliated
company. These comprehensive
molecular analysis tools are designed to
provide critical information to the clinical study
team regarding the molecular alterations associated
with the patient’s cancer, further enhancing patient
care.
The single center, open label clinical study is estimated to
enroll 30 participants with recurrent or refractory HER2-positive
glioblastoma. A parallel HER2.taNK clinical study is also
being planned for the United States that will further expand the
study into other solid tumor
types. Additional information regarding the clinical
study can be found
at http://clinicaltrials.gov, NCT03383978.
About NantKwest Inc.
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.
The 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.
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NantWorksJen HodsonJen@nantworks.com
NantKwest (NASDAQ:NK)
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