- Complete Responses Noted in Multiple Tumor Types (including
Pancreatic Cancer, Triple Negative Breast Cancer, Head and Neck
Cancer, Merkel Cell Cancer, Bladder Cancer, and Non-Hodgkin’s
Lymphoma) when Natural Killer cells and T cells are activated
simultaneously
- FDA Registrationfilings in Bladder, Lung, Merkel Cell, and
Pancreatic cancer anticipated over the next five years
- Received Breakthrough Therapy Designation from FDA for N-803,
IL -15 Fusion Protein for BCG-unresponsive non-muscle invasive
bladder carcinoma in situ (CIS)
- Encouraging efficacy data supports Dr. Soon-Shiong’s hypothesis
that utilizing the tumor itself as a source of antigens and
orchestrating NK cells and T cells will induce immunogenic cell
death, and thereby achieve durable complete remission in cancers
across multiple tumor types
Patrick Soon-Shiong, M.D., Chairman and CEO of NantKwest, Inc.
and ImmunityBio, Inc. presented an update of the Cancer
Breakthrough 2020 Initiative (the “Initiative”) and findings on the
preliminary safety and early signals of efficacy in Phase 1 and 2
trials for multiple tumor types at the 2020 J.P. Morgan Healthcare
Conference on January 14, 2020 in San Francisco.
“We hypothesized that a common treatment protocol that harnesses
both the natural-killer cell and T cells could be effective in
inducing immunogenic cell death leading to durable responses across
multiple tumor types. We are grateful for the support of the FDA
and over 200 investigators in 41 states who have been involved in
testing this hypothesis in cancer patients with advanced disease,”
said Soon-Shiong. “The number of patients who experienced a
complete remission in this advanced setting is encouraging and
further validates our premise that high-dose chemo is harmful and
that a paradigm change of exposing the tumor to a carefully
orchestrated ‘triple triangle offense’ of NK cell, Dendritic cell
and T-cell activation, is a safe cellular and immunotherapy regimen
and can be administered in the outpatient setting with promising
activity across multiple tumor types. Testing this hypothesis has
been the basis of the QUILT trials since 2017.”
Dr. Soon-Shiong first announced the Initiative, whose goal is to
create a new standard of care for a wide range of cancers, at the
2016 J.P. Morgan Healthcare Conference. The Initiative has made
significant progress based on research and clinical trials in the
following areas:
- Obtained 39 Investigational New Drugs (IND) authorizations from
the FDA from 2017 to 2019 to undertake Phase 1 and 2 trials across
multiple tumor types to assess safety and efficacy with 10
first-in-human immunotherapy agents as single agents and in novel
combinations;
- Activated 206 clinical trial sites and over 200 investigators
in 41 states since 2016, with 20 clinical trials actively
enrolling;
- Tested combination immunotherapy of Natural Killer (NK) cells,
checkpoint inhibitors, and fusion proteins, with over 700 doses of
off-the-shelf NK cells (representing over a trillion NK cells)
safely administered as outpatient therapy to 53 patients since
2017;
- Chemotherapy-free responses noted in patients with bladder
cancer, lung cancer, Merkel cell cancer, and Non-Hodgkin’s
Lymphoma;
- Phase 2 studies ongoing with over 100 patients with non-small
lung cancer and over 200 patients with Bladder Cancer studied to
date;
- Reported novel, first-in-human immunotherapy agents and genomic
tumor-normal tests in 94 peer reviewed scientific publications
including The Lancet, Cancer Immunology Research, Nature
Communications and Blood;
- Phase 1 clinical trials were completed for more than ten
first-in-human, first-in-class immunotherapy agents. These trials
were designed to activate both the innate (NK) and adaptive (T
cell) immune systems and were expanded through compassionate use
access across 36 different tumor types in over 350 patients;
- FDA authorized NantHealth’s Omics Core℠, the first custom
targeted whole exome sequencing platform, utilizing solution-phase
exon capture and sequencing, to report somatic alterations (point
mutations, small insertions and deletions) in 468 genes and
sequencing of 19,396 protein-coding genes (whole exome) to
determine overall tumor mutation burden (TMB) in tumor specimens,
TMB is an important test for immunotherapy treatment;
- Breakthrough Therapy Designation awarded by the FDA in
December, 2019 for N-803, IL-15 superagonist that is designed to
activate NK and memory T cells for the treatment of patients with
BCG-unresponsive non-muscle invasive bladder cancer; and
- Based on the safety and efficacy data of the Phase 1 trial in
11 patients with metastatic pancreatic cancer who had received haNK
and N-803, an expanded access regime trial incorporating N-803 with
PD-L1.t-haNK was authorized to study a patient with metastatic
pancreatic cancer who had failed standard of care. After five
infusions of PD-L1.t-haNK and N-803, the patient’s tumor metastasis
resolved completely per CT/PET scan and the complete response has
been confirmed by a repeat CT/PET scan. NantKwest expects to report
this patient’s progress, as well as report data from the full 11
metastatic pancreatic patients enrolled in Quilt 3.064 in
2020.
Interim results of initial signals of safety and efficacy in
these Phase 1 and 2 studies in advanced cancers were reported at
multiple scientific conferences, including The Society of
Immunotherapy of Cancer’s (SITC) 2018 and 2019 conferences, with
complete responses noted in third-line Merkel cell carcinoma and
fourth-line head and neck cancer patients who received combination
immunotherapy, including NantKwest’s haNK CD-16 NK cells combined
with Pfizer’s PD-L1 antibody, Avelumab, and with ImmunityBio’s
N-803, IL-15 superagonist. In addition, the company reported
complete responses using the same combination in Triple Negative
Breast Cancer and observed durable complete responses in these
patients who had failed all standards of care for breast cancer.
The results were presented at the 2019 San Antonio Breast Cancer
Symposium (SABCS) in December 2019. Most recently, exciting data of
long duration response was presented at a plenary session at the
AACR meeting on January 2020. In this Phase 2 trial patients with
lung cancer who had relapsed on checkpoint therapy were then
administered the same checkpoint but with the addition of N-803. In
the patients with high PDL1 non-small lung cancer who had relapsed
on checkpoint therapy, 38 percent responded to the combination of
N-803 plus the same checkpoint, with the duration of response still
ongoing as long as 3 years to date.
A recording of the presentation and slides from the 2020 J.P.
Morgan Healthcare Conference can be viewed on the NantKwest and
ImmunityBio websites, www.NantKwest.com and www.Immunitybio.com
About Cancer Breakthrough 2020
The Cancer Breakthroughs 2020 program, which is one of the most
comprehensive cancer initiatives launched to date, seeks to
accelerate the potential of combination immunotherapy as the next
generation standard of care in cancer patients by inducing
immunogenic cell death and thereby avoiding the adverse effects of
high dose chemotherapy. This national collaborative initiative aims
to explore a new paradigm in cancer care by initiating single-arm
and randomized Phase 2 trials in patients at all stages of disease
in multiple tumor types by 2020. The findings from these initial
studies will inform the pursuit of registration trials for FDA
approval and provide the scientific underpinnings to develop an
effective immunotherapy using the tumor itself as a source of
vaccine antigens to combat cancer by 2025.
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 https://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 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.
About ImmunityBio
ImmunityBio is a privately held immunotherapy company with a
broad portfolio of biological molecules, including an
albumin-linked chemotherapeutic, peptides, fusion proteins,
cytokines, monoclonal antibodies, adenovirus, and yeast vaccine
therapies.
ImmunityBio’s oncological goals are two-fold: To employ its
broad portfolio of biological molecules to activate endogenous NK
and CD8+ T cells, and to develop a T cell memory cancer vaccine to
combat multiple tumor types without the use of high-dose
chemotherapy.
The company’s platform of technologies has enabled it 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). In 2020, ImmunityBio is planning to enroll
patients in late-stage trials with molecules across multiple
indications including triple negative breast cancer, lung cancer,
head and neck cancer, Merkel cell carcinoma, and glioblastoma.
In the field of infectious disease, ImmunityBio’s goal is to
develop vaccine therapies for the prevention and treatment of
Influenza, Zika, Ebola, and HIV. For more information, please visit
our website at https://www.immunitybio.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 ImmunityBio 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
ImmunityBio’s IL-15 based Cytokine therapy, N-803, and other
therapeutics as part of the ImmunityBio 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. We
disclaim any obligation to update these statements except as may be
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200116005291/en/
Media Contact: Jen Hodson 562-397-3639 Jen@nant.com
Investors Contact: Investors@ImmunityBio.com
Investors@NantKwest.com
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