Sorrento Announces IND Filing for COVI-DROPS, an Intranasal Formulation of a High Potency Neutralizing Antibody Against SARS-...
November 11 2020 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
today that it is filing an investigational new drug application
(IND) for intranasal (IN) COVI-DROPS (STI-2099) to study the safety
and pharmacokinetics in both healthy volunteers and patients with
mild COVID-19.
As Sorrento previously announced, in preclinical
studies, high potency STI-2099 demonstrated a 100% neutralizing
effect (both in vitro and in vivo) and at a very low dose prevented
SARS-CoV-2 from infecting healthy cells and causing COVID-19-like
disease in Syrian golden hamsters.
A single intra-nasal administration of STI-2099
12 hours after infection prevented disease-associated weight loss
in treated hamsters. The impact of the treatment was observed
within 24 hours of STI-2099 treatment, demonstrating unique disease
treatment properties as compared to intravenously administered
antibodies.
“We believe STI-2099 has the potential to be
broadly deployable for early treatment in an outpatient setting.
The intranasal route is expected to be enabled by the high potency
of the antibody and is quite promising against this highly
contagious respiratory pathogen,” stated Dr. Henry Ji, Chairman and
CEO of Sorrento Therapeutics. “In addition, it is now understood
that COVID-19 is a local and systemic disease; therefore, we
believe the best course of action would be to attack this highly
contagious pathogenic virus both locally and systemically.”
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™ 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 StatementsThis
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 potency and potential neutralizing profile of STI-2099 and the
impact on SARS-CoV-2; the preclinical testing of STI-2099; the
safety, pharmacokinetics and efficacy of STI-2099; the expectation
of the commencement of any phase 2 trial for STI-2099; the
predictive value of the animal model used in preclinical studies;
the potential potency of STI-2099; the expected effective dose in
humans; the expected administration method of STI-2099; the
potential for STI-2099 to be administered as a combination nasal
and intravenous injection; the potential deployability of STI-2099;
the best course of action against COVID-19; 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 studies and seeking IND regulatory approval for
STI-2099; conducting and receiving results of clinical trials for
STI-2099; the clinical and commercial success of STI-2099 against
preventing and treating SARS-CoV-2 virus infections; the viability
and success of STI-2099 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 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 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, 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.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARD™,
COVI-AMG™, COVI-SHIELD™, COVIDTRAP™, COVI-MAB™, ACE-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.
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Sep 2023 to Sep 2024