Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers an...
March 02 2021 - 4:02PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”)
announced today that it has received clearance from the FDA for its
Investigational New Drug application (IND) for its Phase 1 study of
the safety and pharmacokinetics of intranasal (IN) STI-2099
(COVIDROPS) in both healthy volunteers and patients with mild
COVID-19.
As previously announced, Sorrento is currently
evaluating an intravenous formulation of this potent antibody,
STI-2020 (IV), in a Phase 1 study in healthy volunteers and
COVID-19 patients with mild symptoms. This small volume IV-push
formulation is being tested against the dominant strain of the
SARS-CoV-2 virus in the U.S. as well as the emerging UK variant.
Sorrento expects to evaluate STI-2099 (IN) alone or in combination
with STI-2020 (IV) to treat newly diagnosed patients.
Treatment with STI-2099 has the potential to halt
the COVID-19 infection at the earliest stage in the nasal passages
before it has a chance to spread to the lungs, and, if the
infection has already hit the lungs, prevent the development of
severe infections. If found to be safe and effective following
clinical trials, STI-2099 i has the potential to prevent
hospitalization or discharge hospitalized COVID-19 patients faster.
“We plan to use our intranasal formulation technology, which allows
administering a drug via simple drops in the nose, for other
antibodies we are currently developing with a goal of providing
coverage against all variants of the SARS-CoV-2 virus that might
evade inhibition from treatment with existing therapies,” said Dr.
Henry Ji, Chairman and CEO of Sorrento.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
and COVID-19. 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 COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions,
including COVITRACK™, COVISTIX™ and COVITRACE™.
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 therapeutic potential of STI-2099 and STI-2020 and
their respective impacts on the SARS-CoV-2 virus; the preclinical
and clinical testing of STI-2099 and STI-2020; the potential safety
and effectiveness of STI-2099 and STI-2020; the expectation of
conducting clinical trials to evaluate STI-2099 alone or in
combination with STI-2020; the expected impact STI-2099 and
STI-2020 will have against current and future variants of
SARS-CoV-2 virus; the potential for STI-2099 to halt infection of
the lungs or prevent severe infection; the potential for STI-2099
to prevent hospitalization or accelerate the discharge rate for
hospitalized COVID-19 patients; the expected development of
additional intranasal antibody formulations that have activity
against SARS-CoV-2 virus variants that evade inhibition; 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 and its subsidiaries', affiliates’ and
partners’ technologies and prospects and collaborations with
partners, including, but not limited to risks related to conducting
pre-clinical and clinical studies and seeking regulatory approval
for STI-2099, including the timing for receipt of any such
approval; conducting and receiving results of clinical trials;
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 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 that prior test, study and trial results may not
be replicated in future studies and 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 candidates 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, 2020, 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.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur Pharmaceuticals,
Inc.
ZTlido® is a registered trademark owned by Scilex
Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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