Preclinical and Clinical Data Demonstrate
Advanced Deployment of Precision Medicine Tools to Analyze and
Potentially More Effectively Intervene with Highly Focused
Therapeutic Interventions
NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer
cell based therapeutics company, NantCell Inc., a privately held
immunotherapy company, and NantOmics, a privately held molecular
diagnostic company, today announced that preclinical and clinical
updates will be provided in four abstracts as part of the upcoming
Annual Meeting of the American Society of Clinical Oncology (ASCO)
in Chicago, IL, which runs from May 31st – June 4th, 2019.
Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest, NantCell
and NantOmics, commented, “Through a unique collaboration,
combining the expertise of NantOmics’ multi-omics diagnostic
capabilities with NantKwest’s and NantCell’s therapeutic
capabilities, we are pleased to report for the first time the
ability to comprehensively analyze a patient’s circulating
cell-free RNA (cfRNA) and T Cell Receptor (TCR) repertoire and
therapeutically intervene across a range of tumor types. We believe
this type of fully integrated diagnostic and therapeutic
intervention represent the next-generation in cancer care and shows
real promise in improving response rates in comparison to
traditionally single agent approaches. We look forward to
transitioning these advances in medicine to the clinical care
setting as quickly as possible.”
Abstract Title: Innate and adaptive immunotherapy: An
orchestration of immunogenic cell death by overcoming immune
suppression and activating NK and T-cell therapy in patients with
third line or greater Triple-Negative Breast Cancer
(TNBC).
Sub-category: Triple-Negative
Category: Breast Cancer—Metastatic
Meeting: 2019 ASCO Annual Meeting
Abstract Number: e12566
Citation: J Clin Oncol 37, 2019 (suppl; abstr e12566)
Author(s): Chaitali Singh Nangia, Mira Kistler, Leonard
S. Sender, John H. Lee, Frank R. Jones, Omid Jafari, Patrick
Soon-Shiong; Chan Soon Shiong Institute for Medicine, Laguna Hills,
CA; Chan Soon Shiong Institute of Medicine, El Segundo, CA;
Children's Hospital of Orange County, Laguna Hills, CA; Sanford
Health, Sioux Falls, SD; Etubics Corporation, Seattle, WA; Medical
Imaging Center of Southern California, Santa Monica, CA; NantKwest,
Culver City, CA
Summary: Triple-negative breast cancer (TNBC) is a
heterogenous subtype of breast cancer that is frequently aggressive
and has limited treatment options. We hypothesize that effective
and sustained response against TNBC requires a coordinated approach
that: (1) reverses the immune-suppressive tumor microenvironment,
(2) induces immunogenic tumor cell death and (3) Re-engages NK and
T-cell tumor response against a cascade of tumor antigens. To test
this hypothesis, we have developed a temporospatial approach that
combines metronomic low dose chemotherapy, SBRT, off-the-shelf
cryopreserved allogeneic NK cells, yeast and adenoviral
tumor-associated antigen vaccines, an IL-15RαFc superagonist, and
checkpoint inhibition. Methods: A phase 1b trial in patients with
previously-treated metastatic TNBC was initiated. Treatment
occurred in 3-week cycles of low-dose chemotherapy (aldoxorubicin,
cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L),
antiangiogenic therapy (bevacizumab), SBRT, engineered allogeneic
CD16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based
CEA, MUC1, brachyury, and HER2 vaccines, yeast vector-based Ras,
brachyury and CEA vaccines, and an IgG1 PD-L1 inhibitor, avelumab.
The primary endpoint is incidence of treatment-related adverse
events (TRAEs). Secondary endpoints include ORR, DCR, PFS, and OS.
Preliminary results reported on 8 subjects treated with 3rd-line or
greater TNBC that have received at least 3 treatment cycles (mean =
6 cycles). All treatment was administered in an outpatient setting.
All subjects had at least 1 grade ≥3 TRAE, primarily
chemotherapy-related neutropenia. Grade ≥3 haNK-related AEs (fever
and fatigue) were observed in 2 subjects. 2 subjects experienced
SAEs. 7 subjects remain alive, with 6 subjects receiving ongoing
study treatment. 1 CR (confirmed) and 2 PRs (one confirmed) have
been observed to date. These preliminary data suggest that low-dose
chemo-radiation combined with innate and adaptive immunotherapy can
be administered safely in an outpatient setting with a manageable
safety profile. Clinical trial information: NCT03387085.
Abstract Title: Innate and adaptive immunotherapy: An
orchestration of immunogenic cell death by overcoming immune
suppression and activating NK and T cell therapy in patients with
third line or greater metastatic pancreatic cancer.
Sub-category: Pancreatic Cancer
Category: Gastrointestinal (Noncolorectal) Cancer
Meeting: 2019 ASCO Annual Meeting
Abstract Number: e15787
Citation: J Clin Oncol 37, 2019 (suppl; abstr e15787)
Author(s): Tara Elisabeth Seery, Mira Kistler, Leonard S.
Sender, John H. Lee, Arvind Manohar Shinde, Anand Annamalai,
Patrick Soon-Shiong; Chan Soon Shiong Institute for Medicine,
Laguna Hills, CA; Chan Soon Shiong Institute of Medicine, El
Segundo, CA; Chan Soon Shiong Institute for Medicine, El Segundo,
CA; NantKwest, Culver City, CA; St. Vincent Medical Center, Los
Angeles, CA; St. Vincent's Medical Center, Los Angeles, CA
Summary:
Pancreatic cancer has multiple mechanisms to prevent immune
recognition that lead to the creation of an immune suppressive
tumor microenvironment. Our hypothesis is that sustained response
against pancreatic cancer requires a coordinated approach that: (1)
reverses the immune-suppressive tumor microenvironment, 2. induces
immunogenic tumor cell death and (3) re-engages NK and T-cell tumor
response against a cascade of tumor antigens. To test this
hypothesis, we have developed a temporospatial approach that
combines metronomic low-dose chemotherapy, SBRT, cryopreserved
allogeneic NK cells, yeast and adenoviral tumor-associated antigen
vaccines, an IL-15RαFc superagonist, and checkpoint inhibition.
These preliminary data suggest that low-dose chemo-radiation
combined with innate and adaptive immunotherapy can be administered
safely in an outpatient setting.
Preliminary results of 12 subjects treated with 3rd-line or
greater metastatic pancreatic cancer. All treatment was
administered in an outpatient setting. AEs were primarily
hematologic and managed by planned chemo dose reduction. Grade ≥3
TRAEs were observed in 9 out of 12 subjects, predominately
chemotherapy-related neutropenia. 9 out of 12 subjects (75%) had a
best response of stable disease (≥ 8 weeks). Median PFS is 7.1
months (4.4 – 8.8) and median OS is 8.2 months (5.7 – 9.7) with 1
subject continuing treatment
Preliminary Overall Survival of 8.2 months is encouraging for
this heavily-pretreated population. Clinical trial information:
NCT03586869.
Abstract Title: Correlation between circulating cell-free RNA
biomarkers and response during combination immunotherapy in
previously refractory metastatic TNBC patients.
Sub-category: Circulating Biomarkers
Category: Developmental Immunotherapy and Tumor
Immunobiology
Meeting: 2019 ASCO Annual Meeting
Abstract No: e14027
Citation: J Clin Oncol 37, 2019 (suppl; abstr e14027)
Author(s): Chad Garner, Tara Elisabeth Seery, Chaitali
Singh Nangia, John H. Lee, Liyang Huang, Leonard S. Sender,
Shahrooz Rabizadeh, Patrick Soon-Shiong; NantHealth, Culver City,
CA; Chan Soon Shiong Institute for Medicine, Laguna Hills, CA;
NantKwest, Culver City, CA; Chan Soon-Shiong Institute for
Medicine, El Segundo, CA; NantOmics, LLC, Culver City, CA; CSS
Institute of Molecular Medicine, Culver City, CA.
Summary: A commercial liquid biopsy test was included as
an exploratory component of an integrated immunotherapy clinical
trial in previously refractory metastatic TNBC patients, combining
innate, high-affinity natural killer cell (haNK) therapy with
adenoviral and yeast-based vaccines and an IL-15 superagonist (NCT
03387085). The purpose of the study was to assess the utility of
cell-free circulating RNA (cfRNA) as a predictor of treatment
response. The amount and variability of cfRNA was found to be
positively correlated with the tumor size. As cfRNA quantity and
variability increased or decreased, a corresponding increase or
decrease in tumor size was observed, respectively. Not all 18 genes
showed consistent patterns of change across the six patients,
however the average expression and variability of the 18 genes
showed evidence of a correlation with tumor size change from
baseline (p-values = 0.08 and 0.03, respectively). Only trace
levels of PD-L1 expression were observed in all 6 patients at
baseline, prior to the initiation of the combination immunotherapy.
Among the 5 patients that showed a reduction in tumor size of at
least 10%, 4 also showed an associated increase in cfRNA PD-L1
expression from nearly 0 to normalized values between 2.1 and 6.8.
In an exploratory analysis in an ongoing combination immunotherapy
clinical trial for TNBC showed that increasing and decreasing cfRNA
levels are correlated with increasing and decreasing tumor size,
respectively. Increased PD-L1 cfRNA levels are correlated with
beneficial treatment response. Liquid biopsy of cfRNA could provide
an effective biomarker of treatment response. Clinical trial
information: NCT03387085.
Abstract Title: TCR repertoire analysis from peripheral blood
for prognostic assessment of patients during treatment
Sub-category: Circulating Biomarkers
Category: Developmental Immunotherapy and Tumor
Immunobiology
Meeting: 2019 ASCO Annual Meeting
Abstract Number: e14040
Citation:J Clin Oncol 37, 2019 (suppl; abstr e14040)
Author(s): Sadanand Vodala, Andrew Nguyen, Noe Rodriguez,
Peter Sieling, Charles Joseph Vaske, Jon Van Lew, Kayvan Niazi,
John H. Lee, Patrick Soon-Shiong, Shahrooz Rabizadeh; NantOmics,
LLC, Culver City, CA; NantOmics, LLC, Santa Cruz, CA; NantBio, Inc,
Culver City, CA; Sanford Health, Sioux Falls, SD; NantKwest, Culver
City, CA
Summary:
Immune checkpoint inhibitor therapy offers substantial clinical
advantage to a subset of patients but predictive/novel prognostic
indicators are still scarce. T cell receptors (TCRs) play a crucial
role in adaptive immunity and anti-tumor immune responses. Net
diversity of TCR repertoires are altered in patients receiving
immune checkpoint inhibitors. To study the prognostic significance
of T cell repertoires as a biomarker of immune responses in cancer
patients, TCR repertoires were characterized from peripheral blood
using high throughput sequencing. Patients that show positive
response had TCR clones that were stable, which may indicate an
existing immune related response towards their tumor. TCR-targeted
therapy potentially allows these existing T-cells to overcome
blockade by tumor cells. Patients showing poor response show a TCR
repertoire that is constantly changing potentially indicating that
the tumor cells are not eliciting a strong T cell specific
response. Further functional studies of T cell populations are
planned to expand our understanding of T cell based immune
therapies.
For additional information, please visit www.nantkwest,
www.nantcell.com, and www.nantomics.
About NantKwest
NantKwest, a member of the NantWorks ecosystem of companies, is
an innovative clinical-stage immunotherapy company focused on
harnessing the power of the innate immune system by using the
natural killer cell to treat cancer and virally induced infectious
diseases.
NantKwest is uniquely positioned to implement precision cancer
medicine, with the potential to change the current paradigm of
cancer care. Natural Killer (NK) cells are a safeguard in the human
body designed to recognize and detect cells under stress due to
cancer or viral infection. NantKwest’s “off-the-shelf” activated NK
cell platform is designed to destroy cancer and virally infected
cells from the body. The safety of our 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. In addition to being
a universal cell-based therapy that does not require individualized
patient sourcing or matching, our NK cell products have been
largely administered in the outpatient setting as an
“off-the-shelf” living drug.
With the capacity to grow active killer cells as a living cancer
therapy, our NK cells have been designed to induce cell death
against cancers and virally infected cells by several mechanisms,
including: (i) innate killing, whereby all of our NK platforms
recognize the stress proteins typically found on cancer cells,
which, upon binding, release toxic granules to immediately kill
their targets; (ii) antibody-mediated killing with our haNK®
platform, which are NK cells engineered to express antibody
receptors that can bind to therapeutic antibody products, thereby
enhancing the cancer cell killing effect of that antibody; and
(iii) Chimeric Antigen Receptor directed killing using the taNK®
platform, which includes NK cells engineered to incorporate
chimeric antigen receptors (CARs) to target tumor-specific antigens
found on the surface of cancer cells. All three modes of killing
(innate, antibody-mediated, and CAR directed killing) are employed
by our t-haNK™ platform, which is an innovative combination of our
aNK, haNK® and taNK® platforms in a single product.
Our haNK®, and t-haNK™ platforms have been designed to address
certain limitations of CAR T-cell therapy including the capability
to infuse cell therapy in an outpatient setting which allows for
potential reduction of risk for serious cytokine storms and
protracted serious adverse events. In Phase I and II clinical
trials in patients with late stage cancer, our NK cells have been
administered as an investigational outpatient infusion safely with
greater than 300 infusions to date at a dose of 2 billion cells per
infusion. By leveraging an integrated and extensive genomics and
transcriptomics discovery and development engine, together with a
pipeline of multiple, clinical-stage, immuno-oncology programs, 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. NK-92, aNK, haNK, taNK, and t-haNK are
trademarks of NantKwest, Inc.
For more information please visit www.nantkwest.com
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 March 31, 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.
About NantCell
NantCell is a privately held immunotherapy company with one of
the broadest portfolios of biological molecules spanning
albumin-linked chemotherapeutic, peptide, fusion protein, cytokine,
monoclonal antibody, adenovirus and yeast vaccine therapies.
This platform of technologies has enabled NantCell to achieve
one of the most comprehensive late stage clinical pipelines
addressing both the innate (activated macrophage and natural killer
cell) and the adaptive immune system (dendritic, CD4 and CD8 killer
T cells). The pipeline constitutes over 40 immunological assets
with 13 first in human immunotherapy molecules in active clinical
trials. In 2019, NantCell is planning the enrollment of patients in
late stage trials with 3 molecules across 17 indications in solid
and liquid tumors.
In the field of oncology, NantCell’s goal is to employ a broad
portfolio of biological molecules that will enable it to activate
endogenous NK and CD8+ T cells, and develop a T cell memory cancer
vaccine to combat multiple tumor types without the use of high-dose
chemotherapy.
In the field of infectious disease, NantCell’s goal is to
develop vaccine therapy to treat and prevent diseases stemming from
HIV, Influenza, Zika, and Ebola infection.
For more information please visit www.nantcell.com
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 NantCell 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
NantCell’s IL-15 based Cytokine therapy, N-803, and other
therapeutics as part of the NantCell portfolio.
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.
About NantOmics
NantOmics, a member of the NantWorks ecosystem of companies,
invented and developed the technologies that drive NantHealth’s GPS
Cancer® platform. GPS Cancer® provides actionable intelligence and
molecularly driven decision support for cancer patients and their
providers at the point of care. NantOmics is the first molecular
analysis company to pioneer an integrated approach to unearthing
molecular variances and profiles that initiate and drive cancer, by
analyzing both normal and tumor cells from the same patient and
following identified variances from DNA to RNA to protein to drug.
Having pioneered tumor-normal DNA sequencing and introduced whole
RNA transcriptomic analysis to better inform clinical treatment
decisions, NantOmics has provided molecular insights for thousands
of cancer patients.
NantOmics has a highly scalable cloud-based infrastructure
capable of storing and processing thousands of genomes a day,
computing genomic variances in near real-time and correlating
proteomic pathway analysis with quantitative gene expression and
pharmacogenomic signatures, which guides the use of
immunotherapies, chemotherapies and targeted therapies. Clinical
studies for neoepitope vaccines using NantOmics’ proprietary
technologies and novel artificial intelligence platforms are
currently underway. For more information please visit
www.nantomics.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190531005152/en/
Media Contact:Jen
Hodson,562-397-3639Jen@nant.comInvestor Contact:David
Pyrce951-551-0949david.pyrce@nantkwest.com
NantKwest (NASDAQ:NK)
Historical Stock Chart
From Mar 2024 to Apr 2024
NantKwest (NASDAQ:NK)
Historical Stock Chart
From Apr 2023 to Apr 2024