Immunotherapy companies led by Dr. Patrick
Soon-Shiong are developing potential coronavirus therapeutics and
vaccines to address the evolving stages of disease from moderate
infection to severe acute respiratory distress syndrome (SARS)
- Vaccine Vector to Protect Against SARS-CoV-2 Infection:
- ImmunityBio’s Ad5: A second -generation adenovirus vaccine
platform with four deletions enabling multiple homologous doses,
even in patients with adenovirus immunity
- Therapeutic Immunomodulators for Patients with Mild to
Moderate COVID-19 Symptoms:
- NantKwest’s haNK: CD-16, off-the-shelf natural killer cells to
enhance antibody killing of infected cells, given alone or combined
with Convalescent Plasma (CP)
- ImmunityBio’s N-803: Interleukin 15 (IL-15) ‘superagonist’
cytokine to stimulate natural killer cells and CD8+ T cells
- Therapeutic for Severe and Critically Ill COVID-19 Patients
on Ventilator Support:
- NantKwest’s MSCs: Bone marrow-derived mesenchymal stem cells
(MSC) to mitigate ‘cytopathic storm’
NantKwest, Inc. (NASDAQ: NK) and ImmunityBio, Inc.,
clinical-stage immunotherapy companies within the NantWorks family
of companies, today announced they are in active discussions with
the U.S. Food and Drug Administration (FDA) for vaccines and
therapeutics to combat COVID-19.
Leveraging ImmunityBio’s expertise in vaccine development and
natural killer cell activation, with a broad platform of
immunomodulators currently in clinical trials for cancer and
infectious diseases, and NantKwest’s extensive experience in
off-the-shelf, cell-based therapeutics, the companies are combining
their resources to design and develop therapeutics and vaccines for
COVID-19.
“We’re in a race against time, but I am confident that, as a
result of the incredible hard work the NantKwest, ImmunityBio, and
the global scientific communities are undertaking, we will find
effective therapeutics and vaccines against this coronavirus,” said
Patrick Soon-Shiong, M.D., Chairman & CEO of NantKwest and
ImmunityBio.
Therapeutics:
The biological, immunological, and physiological status of the
patient’s medical state should inform the treatment strategy to
reverse the infectivity and tissue damage caused by this virus.
ImmunityBio and NantKwest have developed immunomodulator regimens
for COVID-19 based on the biological stage of the patient’s
infection - from the mild, moderate to the severe or critically ill
state.
“In the mild-to-moderate stage of infection, we believe that the
patient’s infection and viral load could be mitigated with natural
killer (NK) and T cell stimulation. Hence, in this early-moderate
stage of the disease, we are proposing clinical trials of N-803
alone, and a second trial of haNK alone, or haNK combined with
convalescent plasma,” said Dr. Soon-Shiong.
Investigational New Drug (IND) applications with the FDA for
these trials are pending. ImmunityBio’s Il-15 ‘superagonist’ N-803
is currently being used in clinical trials for other indications
and has achieved Breakthrough Therapy Designation from the FDA[1]
for the treatment of BCG-unresponsive non-muscle invasive bladder
carcinoma in situ (NMIBC-CIS) patients. It has also demonstrated
encouraging results in lowering the viral load in SHIV-infected
monkeys[2], as announced last month at the Annual Conference on
Retroviruses and Opportunistic Infections (CROI)[3].
“In patients requiring ventilatory support in the severe state
of COVID-19 disease, we are exploring the use of bone
marrow-derived allogenic mesenchymal stem cells (BM-Allo-MSC) to
mitigate the ‘cytopathic storm,’” said Dr. Soon-Shiong.
NantKwest has proprietary isolation and expansion methods for
growing MSCs and is using ImmunityBio’s automated, closed system
(GMP-in-a-Box) to safely and rapidly grow these stem cells from a
bone marrow cell bank in approximately 7-9 days. NantKwest has
filed an IND with the FDA and anticipates beginning trials in Q2
2020.
Vaccines: Developing a platform for both initial
immunizations and subsequent booster injections
First generation Adenovirus platforms (Ad5) currently in use are
disadvantaged by inducing adenovirus neutralizing antibodies, thus
limiting multiple doses and reducing the immune response to the
antigen of interest. ImmunityBio has overcome this obstacle through
the development of a second generation Ad5 platform. Through
multiple deletions in the adenovirus genome, this next generation
platform establishes a vector that is immunologically “quiet” as it
relates to adenovirus protein production in the host dendritic cell
and enables this same Ad5 vector to serve both as a prime and a
boost treatment, even in patients with pre-existing adenovirus
immunity. This second-generation Ad5 [E1-, E2b-, E3- deleted]
platform has demonstrated safety in Phase I and Phase II studies in
immunosuppressed cancer patients.
Furthermore ImmunityBio has extensive infectious disease
experience with this second generation Ad5 platform and has
published several peer-reviewed articles on studies demonstrating
humoral and cell mediated immunity in H1N1 Influenza[4], HIV[5],
SIV[6], Lassa Fever[7], Chikungunya, and Zika virus infections.
“While development of therapies is urgently needed in this
crisis, as urgent is the need to develop a vaccine with
long-lasting cell-mediated immunity. Developing vaccines in the
time of pandemics requires novel approaches and the use of
modernized genomics, molecular dynamics, and vectors that are
proven to induce cell-mediated immunity, with mass scale production
capabilities. In 2009, with the H1N1 crisis, the scientific team
developing this second generation Ad5 platform demonstrated that
such a vaccine for the H1N1 pandemic could be developed in six
weeks from identification of the H1N1 sequence. This experience in
2009 allows ImmunityBio to respond as rapidly as possible to the
COVID-19 pandemic,” continued Dr. Soon-Shiong. “I view the spike
(S) protein and the nucleocapsid (N) protein as the equivalent of a
neoantigen in cancer. A recent study by the National Cancer
Institute (NCI) in patients with advanced cancer, published in The
Oncologist[8] reported positive evidence that this platform could
induce antigen-specific T cell immunity, even in the face of
previous adenoviral immunity,” said Dr. Soon-Shiong. Together with
our scientific collaborators at the NCI, we have recently published
evidence[9] that the Ad5 platform can successfully induce
cell-mediated immunity following the administration of
Ad5-Neoantigens, with total remission of the tumor in pre-clinical
models. Based on these findings, we are hopeful that the Ad
platform could induce a similar immune response to this novel
Coronavirus antigen.”
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. 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 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 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 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 Annual Report on Form 10-K for
the year ended December 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 ImmunityBio
ImmunityBio, Inc. is a privately-held immunotherapy company with
a broad portfolio of biological molecules at clinical stages of
development. The company’s goals are to employ this portfolio to
activate endogenous natural killer and CD8+ T cells in the fields
of cancer and infectious disease. Specifically, ImmunityBio’s goal
is to develop a memory T-cell cancer vaccine to combat multiple
tumor types—without the use of high-dose chemotherapy. Regarding
infectious disease, ImmunityBio is addressing HIV, influenza, and
the coronavirus.
ImmunityBio’s first-in-human platform of technologies has
enabled it to achieve one of the most comprehensive, late-stage
clinical pipelines, activating both the innate (natural killer
cell) and adaptive immune systems. The product pipeline includes an
albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15
cytokine superagonist (N-803), checkpoint inhibitors, macrophage
polarizing peptides, bi-specific fusion proteins targeting TGFb and
IL-12, adenovirus, and yeast vaccine therapies targeting
tumor-associated antigens and neoepitopes.
In December 2019, the U.S. Food and Drug Administration (FDA)
granted Breakthrough Therapy Designation to N-803 for
BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).
Other indications currently at registration-stage trials include
BCG-unresponsive papillary bladder cancer, first- and second-line
lung cancer, and metastatic pancreatic cancer.
ImmunityBio’s goal is to develop therapies, including vaccines,
for the prevention and treatment of HIV, influenza, and the
coronavirus SARS-CoV-2.
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.
[1]: ImmunityBio Granted FDA Breakthrough Therapy Designation
for N-803 IL-15 Superagonist in NMIBC – December 4, 2019
https://www.businesswire.com/news/home/20191204005300/en/ImmunityBio-Granted-FDA-Breakthrough-Therapy-Designation-N-803
[2]: ImmunityBio Announces Durable Virus Control of SHIV Without
Anti-Retroviral Therapy (ART) by Activating NK and Memorty T Cells
with N-803, an IL-15 Superagonist – March 10, 2020
https://immunitybio.com/immunitybio-announces-durable-virus-control-of-shiv-without-anti-retroviral-therapy-by-activating-nk-and-memory-t-cells-with-n-803-an-il-15-superagonist/
[3]: Combination IL-15 Therapy in a SHIV NHP Model – Presented
at Conference on Retroviruses and Opportunistic Infections (CROI)
March 8-11, 2020 Boston, Massachusetts
http://www.croiconference.org/sessions/combination-il-15-therapy-shiv-nhp-model
[4]: Prevention of Influenza Virus Shedding and Protection from
Lethal H1N1 Challenge Using a Consensus 2009 H1N1 HA and NA
Adenovirus Vector Vaccine. Vaccine. 2011 Sep 16; 29(40): 7020–7026.
Published 2011 Aug 5. doi:
10.1016/j.vaccine.2011.07.073
[5]: Induction and Comparison of SIV Immunity in Ad5 Naïve and
Ad5 Immne Non-Human Primates Using an Ad5 [E1-, E2b-] Based
Vaccine. Vaccine. 2011 Oct 19;29(45):8101-7. doi:
10.1016/j.vaccine.2011.08.038. Epub 2011 Aug
22.
[6]: Control of SIV Infection and Subsequent Induction of
Pandemic H1N1 Immunity in Rhesus Macaques Using an Ad5 [E1-, E2b-]
Vector Platform.Vaccine. 2012 Nov 26; 30(50): 7265–7270. Published
2012 Oct 2. doi:
10.1016/j.vaccine.2012.09.058
[7]: Adenoviral Vector-Based Vaccine is Fully Protective Against
Lethal Lassa Fever Vhallenge in Hartley Guinea Pigs. Vaccine..2019
Oct 23;37(45):6824-6831. doi:
10.1016/j.vaccine.2019.09.030. Epub 2019 Sep
24.
[8]: A Phase I Trial Using a Multitargeted Recombinant
Adenovirus 5 (CEA/MUC1/Brachyury)‐Based Immunotherapy Vaccine
Regimen in Patients with Advanced Cancer. The Oncol.
doi:10.1634/theoncologist.2019-0608
[9]: Efficient Tumor Clearance and Diversified Immunity Through
Neoepitope Vaccines and Combinatorial Immunotherapy. Cancer
Immunology Research July 2019 DOI:
10.1158/2326-6066.CIR-18-0620
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200414005353/en/
Jen Hodson NANT Jen@nant.com 562-397-3639
NantKwest (NASDAQ:NK)
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