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™ 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.
Media and Investor
Relations
Contact: Alexis Nahama, DVM (SVP Corporate
Development)Telephone: 1.858.203.4120Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARDTM,
COVI-SHIELD™, COVIDTRAP™, COVI-MAB™, ACE-MABTM, Gene MAb™,
COVI-DROPS™, COVI-TRACK™, COVI-TRACE™, COVI-STIX™, and COVI-MOBILE™
are trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals Inc.All other trademarks are the property of their
respective owners.© 2020 Sorrento Therapeutics, Inc. All Rights
Reserved.
Approved for public release: distribution
unlimited.
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