http://www.mitbbs.com/article_t/Military/58801465.html
发信人: lubbock12 (非老非小将), 信区: Military
标 题: 日,季博士的全资子公司直接拿到美国国防部的订单了,牛逼!
发信站: BBS 未名空间站 (Fri Nov 27 13:42:37 2020, 美东)
直接从DARPA和JPEO生化武器研究项目拿到合同了,生产基因编码抗新冠抗体。
DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for
Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded
Neutralizing Antibodies
Fri, November 27, 2020, 8:00 AM EST
Initial funding of up to $34 million for the project "Gene Mabs: A Scalable
, Economic, Gene-Encoded Protective Antibody Platform Against Coronavirus"
(HR0011-21-9-0015) to support the development of an STI-2020-encoded Gene
MAbTM through Phase 2 clinical studies.
STI-2020-encoded Gene MAb is in development for intramuscular injection
against the SARS-CoV-2 virus and its variant strains to produce potent STI-
2020 nAbs in the body.
STI-2020-encoded Gene MAb products can potentially be stored at refrigerator
temperatures, avoiding some of the cold chain management challenges
associated with the deployment of COVID-19 vaccines currently in development.
Sorrento has a cGMP facility in place to meet initial production demand and
Sorrento expects that STI-2020-encoded Gene MAb can be produced in large
quantity to meet potentially high demand.
SAN DIEGO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- SmartPharm Therapeutics, Inc. (
"SmartPharm"), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. (
Nasdaq: SRNE, "Sorrento"), and developer of next-generation, non-viral
gene therapy technologies, announced today that it has been awarded a
contract from the Defense Advanced Research Projects Agency (DARPA) co-
funded by the Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid
countermeasure to COVID-19. The contract would provide SmartPharm up to USD
$34 million for development through Phase 2 clinical studies of a gene-
encoded antibody ("Gene MAb") that could enable rapid protection from and/
or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek
further funding in support of the COVID Gene MAb program toward EUA (
emergency use authorization) approval and large-scale manufacturing pending
successful clinical studies.
For this Gene MAb approach, the SmartPharm/Sorrento team will produce
plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020 (COVI-AMG
™). The FDA is currently reviewing IND filings for STI-2020 as an IV-
delivered neutralizing antibody and STI-2099 as an intranasal-delivered
neutralizing antibody for the treatment of COVID-19. The expected higher
potency of the STI-2020 antibody makes it an ideal candidate for Gene MAb
delivery against COVID-19.
The DARPA/JPEO contract supports the accelerated development of a Gene MAbs
neutralizing antibody that can be delivered by a simple intramuscular
injection, enabling the recipient to produce the protective antibody,
potentially within days of the injection. Such an approach would permit the
rapid translation of fully characterized potent neutralizing antibodies into
clinical use, which Sorrento believes will be important for responding to
potential mutations of SARS-CoV-2 that may emerge. It would also enable
broader deployment of the Gene MAb approach as a prophylactic solution, as
it can be conveniently administered into the muscle like an annual flu
vaccine. If successful, it could provide an alternative method of protecting
populations where vaccines do not work as well, such as the elderly or
immunocompromised.
Dr. Henry Ji, CEO of Sorrento, commented, "We are excited that DARPA and
JPEO have recognized our Gene MAbs platform as a potential rapid
countermeasure for COVID-19 and the potential value for other applications
to combat future viral diseases of pandemic potential. We acquired
SmartPharm with the vision of combining the power of our antibody and
biologic therapies for cancer and infectious diseases with next-generation
gene-encoded technologies. We look forward to working with our Department of
Defense partners to potentially add a novel approach to the arsenal of
solutions for combating this devastating disease."
DARPA, founded in 1958, is an agency of the U.S. Department of Defense.
Through collaborations with academic, industry, and government partners,
DARPA makes investments across multiple sectors to drive breakthrough
technologies for U.S. national security. Through the collaboration with JPEO
-CBRND, this work is supported by the Office of the Assistant Secretary of
Defense for Health Affairs with funding from the Defense Health Agency.
About SmartPharm Therapeutics
SmartPharm Therapeutics, Inc., a wholly owned subsidiary of Sorrento
Therapeutics, Inc. (Nasdaq: SRNE), is a development stage biopharmaceutical
company focused on developing next-generation, non-viral gene therapies for
the treatment of serious or rare diseases with the vision of creating "
biologics from within." SmartPharm is currently developing a novel pipeline
of non-viral, gene-encoded proteins for the treatment of conditions that
require biologic therapy such as enzyme replacement and tissue restoration.
SmartPharm commenced operations in 2018 and is headquartered in Cambridge,
MA, USA. For more information, please visit www.smartpharmtx.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company
developing new therapies to treat cancers. Sorrento's multimodal,
multipronged approach to fighting cancer is made possible by its extensive
immuno-oncology platforms, including key assets such as fully human
antibodies ("G-MAB™ library"), clinical stage immuno-cellular
therapies ("CAR-T", "DAR-T™"), antibody-drug conjugates ("ADCs"), and
clinical stage oncolytic virus ("Seprehvir®"). Sorrento is also
developing potential antiviral therapies and vaccines against coronaviruses,
including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene MAb&
#8482; and COVI-DROPS™; and diagnostic test solutions, including COVI-
TRACK™, COVI-STIX™ and COVI-TRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also
demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-
opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (
10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel
, viscous gel formulation of a widely used corticosteroid for epidural
injections to treat lumbosacral radicular pain, or sciatica, and to
commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment
of post-herpetic neuralgia. RTX has completed a phase IB trial for
intractable pain associated with cancer and a phase 1B trial in
osteoarthritis patients. SEMDEXA is in a pivotal phase 3 trial for the
treatment of lumbosacral radicular pain, or sciatica. ZTlido® was
approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Forward-Looking Statements
This press release and any statements made for and during any presentation
or meeting contain forward-looking statements related to Sorrento
Therapeutics, Inc., under the safe harbor provisions of Section 21E of the
Private Securities Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially from
those projected. Forward-looking statements include statements regarding the
aggregate amount of funding available pursuant to the DARPA contract; the
development of a Gene MAb against SARS-CoV-2 infection and COVID-19; the
expectation of the commencement of any clinical trials for a Gene MAb,
including phase 2 clinical studies; the potential for a Gene Mab to provide
rapid protection and/or treatment of SARS-CoV-2 infection and COVID-19; the
potential potency and potential neutralizing profile of STI-2020 and its
impact on COVID-19; the potential potency and potential neutralizing profile
of STI-2099 and its impact on COVID-19; the expected administration of STI-
2020 and STI-2099; the potential for STI-2020 to be an ideal candidate for
gene-mediated delivery; the potential administration method of a Gene MAb
neutralizing antibody; the potential ability of a recipient of a Gene MAb
neutralizing antibody to produce protective antibodies; the expected timing
for a recipient of a Gene MAb neutralizing antibody to begin producing
protective antibodies; the ability of a Gene MAbs platform to translate
recognized neutralizing antibodies into clinical use; the potential for a
Gene MAb neutralizing antibody approach to COVID-19 to be used as a
prophylactic solution; the potential for a Gene MAb neutralizing antibody to
provide an alternative method of protection against SARS-CoV-2 and COVID-19
; the potential for a Gene MAbs platform to be used with future viral
diseases; the potential for Gene MAb products to be stored at room
temperature and/or in refrigeration to avoid cold chain management concerns;
the potential for Sorrento's cGMP facility to meet initial production
demand; the potential for Sorrento to mass produce sufficient quantities of
STI-2020-encoded Gene MAb to meet demand; the ability of Sorrento to combine
its antibody and biologic therapies with SmartPharm's gene-encoded
technologies; and Sorrento's potential position in the antiviral industry.
Risks and uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our forward-looking
statements, include, but are not limited to: risks related to Sorrento's
technologies and prospects with newly acquired technologies, including the
acquisition of SmartPharm and the utilization of SmartPharm's Gene-Encoded
Therapeutics (GET) platforms for the treatment and prevention of coronavirus
infections and other pathogens and cancer cells; risks related to seeking
regulatory approvals and conducting clinical trials; the clinical and
commercial success of the treatment and prevention of coronavirus infections
using gene-encoded antibodies; the viability and success of using gene-
encoded antibodies for treatments in anti-viral therapeutic areas, including
coronaviruses; clinical development risks, including risks in the progress,
timing, cost and results of clinical trials and product development
programs; risk of difficulties or delays in obtaining regulatory approvals;
risks that prior study and trial results may not be replicated in future
studies and trials; risks that clinical study results may not meet any or
all endpoints of a clinical study and that any data generated from such
studies may not support a regulatory submission or approval; risks related
to seeking regulatory approvals and conducting clinical trials; risks of
manufacturing and supplying drug product; risks related to leveraging the
expertise of its employees, subsidiaries, affiliates and partners to assist
the company in the execution of its COVID-19 therapeutic product candidate
strategies; risks related to the global impact of COVID-19; and other risks
that are described in Sorrento's most recent periodic reports filed with the
Securities and Exchange Commission, including Sorrento's Annual Report on
Form 10-K for the year ended December 31, 2019, and subsequent Quarterly
Reports on Form 10-Q filed with the Securities and Exchange Commission,
including the risk factors set forth in those filings. Investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release and we undertake no
obligation to update any forward-looking statement in this press release
except as required by law.
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