First patient receives ImmunityBio’s
second-generation hAd5 COVID vaccine, delivering both outer S
(spike) protein and inner N (nucleocapsid) leading to potential
long-term T cell and antibody immunity to the SARS-CoV-2 virus
ImmunityBio, a privately-held immunotherapy company, and
NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer
cell-based therapeutics company, today announced that the first
patient has been dosed in the Phase 1 clinical trial of
hAd5-COVID-19, a novel COVID-19 vaccine candidate that targets the
inner nucleocapsid (N) and the outer spike (S) protein, engineered
to activate both T cells and antibodies against the coronavirus
(SARS-CoV-2). This is a novel COVID vaccine that uses a
second-generation adenovirus that delivers multiple proteins of the
SARS-CoV-2 with the potential for long-term immunity through memory
T cells. The Phase 1 trial, which is being conducted at the Hoag
Hospital in Newport Beach, California, is currently enrolling
healthy adult subjects up to age 55 with the goal of examining the
safety and reactogenicity of two doses of the vaccine
candidate.
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First patient receives California-based
ImmunityBio’s second-generation hAd5 COVID vaccine, delivering both
outer S (spike) protein and inner N (nucleocapsid) leading to
potential long-term T cell and antibody immunity to the SARS-CoV-2
virus. (Photo: Business Wire)
“Our vaccine candidate, hdA5-COVID-19, targets both the
nucleocapsid protein on the interior of the virus particle and the
spike protein on the virus’ surface,” said Dr. Patrick Soon-Shiong,
Chairman and CEO of ImmunityBio and NantKwest. “We believe this
dual targeting is a key advantage that may lead to the stimulation
of both T-cell-mediated and antibody-mediated immunity to
SARS-CoV-2, which is an important differentiator from other vaccine
candidates that only target the spike protein.”
Dr. Soon-Shiong continued, “A successful vaccine may require the
stimulation of both T-cell-mediated and antibody-mediated immunity,
particularly since studies have shown that patients with SARS-CoV
infection have long-term T cell memory to the nucleocapsid protein.
We believe that our approach, which is based on many years of
experience in cancer research, could provide a robust and effective
vaccine that harnesses the full potential of the immune system as
an important new tool to combat the coronavirus and we look forward
to advancing hAd5-COVID-19, as well as our oral, inhalational and
intranasal candidates.”
About the ImmunityBio hAd5-COVID-19 Vaccine Candidate
NantKwest and ImmunityBio’s hAd5-COVID-19 vaccine candidate is a
uniquely engineered, second-generation human adenovirus serotype 5
vaccine that has been designed to deliver both the spike protein
and nucleocapsid protein by dual constructs of SARS-CoV-2 to
potentially generate B and T cell memory to the COVID-19 antigens
and long-term immunity to the virus. Most of the COVID-19 vaccines
in late-stage clinical trials deliver only the monovalent spike
protein on the surface of the virus to generate blocking
antibodies.
Modified to enhance the safety of the vector and immunogenicity
of the COVID insert, ImmunityBio’s novel human adenovirus vector
has demonstrated preliminary safety in over 125 patients in 13
Phase I and 2 trials to date. Clinical studies performed by the
National Cancer Institute have demonstrated that this novel Ad5
vector induces antigen-specific T-cell immunity in patients, even
in the presence of pre-existing adenoviral immunity.
About the Phase I Clinical Trial
NantKwest and ImmunityBio are currently enrolling 35 healthy
adults aged 18 to 55 years old in the Phase 1 study for the
hAd5-COVID-19 vaccine candidate (NCT04591717). hAd5-COVID-19 will
be administered as both a prime and boost using the same vector
platform to enable sustained protection against SAR-CoV-2. The
study’s main objective is to examine the safety and reactogenicity
of two doses of the vaccine. The companies are also pursuing
development for oral, inhalational, and intranasal administration
of hAd5.
For more information about the trial or to enroll in it, please
contact clinicalresearch@hoag.org.
About ImmunityBio and NantKwest Joint Collaboration
Agreement
Under the terms of a definitive agreement announced on August
24, 2020, ImmunityBio, Inc. and its affiliate NantKwest, Inc.
agreed to share equally the costs of development, manufacturing,
marketing and commercialization of the products each is developing
related to COVID-19, including the hAd5 vaccine candidate. Should a
product be commercialized successfully, the companies have agreed
to a 60-40 percentage split of net profits, with the larger share
going to the company that developed the product. The agreement also
details the structure of shared governance of the joint
collaboration.
About the Hoag Center for Research and Education
The Hoag Center for Research and Education (HCRE) is a strategic
and operational platform that selects, oversees and conducts
government, industry, and foundation sponsored research trials
translating early stage research and development into bedside
patient care. HCRE’s aim is to provide the most advanced device
technology, biopharmaceutical treatments, medical software and
artificial intelligence health applications to the patients in our
community and beyond. HCRE leadership procures, allocates and
oversees the resources and regulatory requirements demanded of
clinical trials, including patient safety and outcomes. Through
nimble collaboration and efficient patient enrollment, HCRE
conducts more than 150 trials annually. Trials span the entire
spectrum of Hoag’s institute programs, including Cancer,
Neurosciences, Women’s, Heart and Vascular, as well as individual
investigator-initiated trials. Examples include anti-cancer vaccine
therapy trials, Phase 1 cancer therapeutics, advanced cardiac and
radiology interventional tools, applications of virtual and
augmented reality tools for patient education and neuromodulation,
cutting edge molecular imaging targets, Alzheimer’s detection and
targeted biotherapeutics.
Since March, Hoag has participated in more than 20 COVID-19
clinical trials, providing patient access to cutting-edge therapies
and innovative treatment including options that have documented
improved outcomes, including decreased mortality and decreased
length of stay for hospitalized COVID-19 patients.
About ImmunityBio
ImmunityBio, Inc. is a late-clinical-stage immunotherapy company
developing next-generation therapies that drive immunogenic
mechanisms for defeating cancers and infectious diseases. The
company’s immunotherapy platform activates both the innate (natural
killer cell and macrophage) and adaptive (T cell) immune systems to
create long-term “immunological memory.” This novel approach is
designed to eliminate the need for high-dose chemotherapy, improve
upon the outcomes of current CAR T-cell therapies, and extend
beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three
separate modalities: antibody cytokine fusion proteins, synthetic
immunomodulators, and second-generation human adenovirus (hAd5)
vaccine technologies.
Anktiva™ (ImmunityBio’s lead cytokine infusion protein) is a
novel interleukin-15 (IL-15) superagonist complex and has received
Breakthrough Therapy and Fast Track Designations from the U.S. Food
and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle
invasive bladder cancer (NMIBC). The company is also in Phase 2 or
3 trials for indications such as first- and second-line lung
cancer, triple-negative breast cancer, metastatic pancreatic
cancer, recurrent glioblastoma, and soft tissue sarcoma in
combination with the company’s synthetic immune modulator
(aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines,
for the prevention and treatment of HIV, influenza, and the
coronavirus SARS-CoV-2 with its second-generation human adenovirus
(hAd5) vaccine technologies.
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 various diseases, including, but not limited to the
novel coronavirus and cancer. Risks and uncertainties related to
this endeavor include, but are not limited to, the company’s
beliefs regarding the success, cost, and timing of its development
activities and clinical trials.
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
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 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 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. The
safety of these optimized, activated NK cells—as well as their
activity against a broad range of cancers—has 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 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
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 or other critical illnesses, including
COVID-19. Risks and uncertainties related to these endeavors
include, but are not limited to, obtaining FDA approval of
NantKwest’s NK cells and MSC as well as other therapeutics and
manufacturing challenges.
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 June 30, 2020. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201021006025/en/
Jen Hodson Jen@nant.com 562-397-3639
NantKwest (NASDAQ:NK)
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