Sorrento Announces FDA Authorization to Proceed with Phase 1 Study of Intravenous STI-9167 (COVISHIELD), a Potent Neutralization Antibody Against Omicron BA.2 and Other SARS-CoV-2 Variants of Concern
April 25 2022 - 9:30AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that it has received clearance from the FDA for its
investigational new drug application (IND) for intravenous (IV)
STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in
healthy volunteers. STI-9167 is the IV formulation of the
intranasal STI-9199 neutralizing antibody.
The Phase 1 study will be conducted at a single
clinical site in the US and will be followed by multinational (USA,
China and Mexico) Phase 2/3 trials. Sorrento plans to discuss with
the FDA the most appropriate end-points for the pivotal study that
could result in an Emergency Use Authorization (EUA), if the trials
meet the efficacy end-points of the pivotal study.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™,
COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including
COVITRACK™ and COVIMARK™.
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 (PHN). RTX has
been cleared for a Phase II trial for intractable pain associated
with cancer and a Phase II trial in osteoarthritis patients.
Positive final results from the Phase III Pivotal Trial C.L.E.A.R.
Program for SEMDEXA™, its novel, non-opioid product for the
treatment of lumbosacral radicular pain (sciatica), were announced
in March 2022. 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 STI-9167 (COVISHIELD); the therapeutic and clinical
potential of STI-9167; the potential safety and efficacy of
STI-9167; the preclinical and clinical testing of STI-9167; the
expectation of conducting a Phase 1 clinical trial, followed by
Phase 2/3 trial(s), to evaluate STI-9167; Sorrento’s plans to
discuss with FDA the endpoint criteria for a pivotal study that
could result in an Emergency Use Authorization for STI-9167; and
Sorrento’s 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, including, but
not limited to risks related to seeking regulatory approval for
STI-9167; 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 Sorrento in the execution of its 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, 2021 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: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ and COVIMARK™ 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.
©2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
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