Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced the release of new data on the Omicron variant
neutralizing antibody (nAb) STI-9167, COVISHIELD, an advanced stage
antibody discovered and developed for clinical trials in an ongoing
collaboration between immunologists and virologists at Sorrento and
the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”)
in New York, NY.
Spike protein binding assays and neutralization
assays using viruses representing all known SARS-CoV-2 variants of
concern (VOCs) have been completed with STI-9167, and this nAb was
observed to bind with high affinity and provide highly potent
neutralizing activity (Omicron IC50 = 25 ng/ml). Of noted
significance, STI-9167 is unique when compared to tests of
EUA-approved SARS-CoV-2 nAbs in that binding and neutralization
properties are maintained against the emerging Omicron and Omicron
(+R346K) variant, an increasingly prevalent Omicron lineage variant
that encodes an additional R346K Spike protein mutation.
Additionally, STI-9167 administered at a low dose (5mg/kg) by
either the intranasal or intravenous routes provided strong
protection against the clinical signs of infection by the Omicron
variant in the K18-hAce2 transgenic mouse model of COVID-19,
preventing weight loss and reducing virus titers in the lungs to
undetectable levels.
“The generation and characterization of the
STI-9167 nAb demonstrates the great collaboration between the
scientists of Mount Sinai and Sorrento to address a global health
crisis,” said Domenico Tortorella, PhD, Professor of Microbiology
at Icahn Mount Sinai.
“We selected antibody STI-9167 from large
sets of diverse anti-SARS-CoV-2 spike neutralizing antibodies
that we developed in our labs. It demonstrated the most effective
cross-neutralization against all known SARS-CoV-2 isolates and
variants of concerns, including the recent Omicron and Omicron
(+R346K) variants,” commented J. Andrew Duty, PhD, Assistant
Professor of Microbiology and Director of the Center for
Therapeutic Antibody Development at Icahn Mount Sinai.
“The currently EUA-approved nAbs have markedly
reduced or absent binding and neutralization activities against
omicron/omicron (+R346K) making them inadequate to support current
clinical needs,” stated Mike A. Royal, MD, JD, MBA, Chief Medical
Officer at Sorrento. “Alternative nAbs are sorely needed in the
near term, particularly for the pediatric population which appears
to be at higher risk for severe omicron infection and
hospitalization. Our intranasal COVIDROPS formulation delivers our
nAbs to the upper airways where Omicron is most likely to target
and flourish, and as a non-invasive, easy to administer treatment,
it is ideal for children. We have already begun to treat children
with COVIDROPS (with STI-2099) in Mexico where the delta variant is
still prevalent. Through Phase 2 studies in the US, United Kingdom
and Mexico, we have seen a benign safety profile for intranasal
delivery of our nAbs and expect a similar outcome with COVIDROP
(with STI-9167).”
“We now have had experience with bringing
multiple COVID-19 therapeutics into the clinic and advancing
several into Phase 2 and/or pivotal development,” says Mark
Brunswick, PhD, SVP and Head of Regulatory Affairs and Quality at
Sorrento. “We are well situated to rapidly bring forth COVISHIELD
through the IND stage and into the clinic and expect to file this
important IND in the next month.”
Dr. Henry Ji, Chairman and CEO of Sorrento,
commented, “The work by the teams at Sorrento and Mount Sinai has
yielded a remarkable antibody with unique and valuable protective
properties against Omicron and all other SARS-CoV-2 VOCs. Our
COVISHIELD neutralizing antibody is the best-in-class and the most
advanced candidate for combatting the prevalent Omicron and
emerging Omicron (+R346K) VOCs. We are working diligently to
position this antibody for use in COVID patients and are confident
that our approach will provide an efficacious clinical solution not
only in the near term but also as the pandemic continues to
evolve.”
A preprint manuscript is published online at biorxiv.org:
https://biorxiv.org/cgi/content/short/2022.01.19.476998v1
The neutralizing antibody described was
generated in the laboratories at Mount Sinai and exclusively
licensed to Sorrento Therapeutics. Mount Sinai and Mount Sinai
faculty members have a financial interest in Sorrento
Therapeutics.
About STI-9167, COVISHIELD,
Antibody
Initially isolated as a SARS-CoV-2 (WA-1 strain)
nAb candidate following vaccination of transgenic mice, the
STI-9167 antibody was optimized to maximize protein stability and
minimize interactions with host Fc gamma receptors. Using
established master cell banks, GMP drug product has been generated
at Sorrento in preparation for anticipated Phase 1 through pivotal
Phase 2/3 human clinical trials. Tech transfer of methods and GMP
processes in support of commercial-scale GMP manufacturing is
currently underway.
About STI-9167 Clinical Development
Plans
Sorrento has demonstrated the protective effects
of SARS-CoV-2 nAbs administered by either intravenous, IV, or
intranasal, IN, routes in preclinical COVID-19 animal models and
the safety of SARS-CoV-2 nAbs administered by IV and IN routes to
human subjects. Current clinical study plans for STI-9167, pending
feedback from regulatory agencies, call for evaluation of safety
following antibody administration at single doses via the IV and IN
routes in healthy normal adults or asymptomatic Omicron infected
patients, followed by large Phase 2/3 clinical trials globally for
newly infected COVID-19 patients.
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 COVISTIX™.
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
cleared for Phase II trial for intractable pain associated with
cancer and a Phase II trial in osteoarthritis patients. SEMDEXA
announced highly statistically significant positive top-line
results from its Phase III Pivotal Trial C.L.E.A.R Program for its
novel, non-opioid product for the treatment of lumbosacral
radicular pain (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 STI-9167, including the potential potency and
neutralizing profile of STI-9167 with respect to SARS-CoV-2 and its
variants of concern (VOCs); the preclinical and clinical testing of
STI-1967; the potential safety and efficacy of STI-1967; the
potential for STI-9167 to exhibit best-in-class neutralization
against SARS-CoV-2 and all of its VOCs, including high potency
against the Omicron and Omicron (+R346K) variants; the expected
impact STI-9167 will have against current and future VOCs of
SARS-CoV-2; the potential for STI-1967 to provide strong protection
against infection by the Omicron variant; the expected dosing
and/or route(s) of administration for STI-9167; Sorrento’s internal
drug product manufacturing capabilities in support of clinical
development and its plans to engage global contract manufacturing
organizations to provide or support commercial-scale manufacturing
capacity; the expectations and timing for submitting
Investigational New Drug (IND) applications for STI-1967 in the US,
UK, Mexico and/or any other territories; the expected
administration method(s) of STI-1967; the potential clinical trial
design for STI-1967; the potential for preliminary data results to
be replicated in preclinical and clinical studies; 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 seeking
regulatory approval for STI-1967; risks related to conducting
preclinical studies and seeking IND acceptance for STI-1967;
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, 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.
Media and Investor
Relations
Contact: Dorman FollowwillEmail:
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 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.
©2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
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