Sorrento Therapeutics has Received FDA Clearance to Initiate Clinical Trials with a Next Generation mRNA (STI-1557) Vaccine Against Omicron SARS-CoV-2 Virus
06 Diciembre 2022 - 8:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") has
received clearance from the US FDA to initiate clinical trials with
STI-1557, its next generation mRNA vaccine against SARS-CoV-2
Omicron variants. This mRNA vaccine incorporates a mutation in the
furin cleavage site that prevents the S1 subunit cleavage from the
spike protein from anchoring on the muscle cell membrane. This
modification was introduced to prevent the leakage of S1 subunit
from the expressed spike protein (S protein) into the blood
circulation, which is known in part to potentially cause
undesirable side effects in vital organ tissues following
administration of the current FDA-approved mRNA vaccines. The mRNA
is encapsulated in a Sorrento proprietary lipid nanoparticle
formulation (LNP) to protect mRNAs from degradation and enable
potent translation of the S protein in host cells after
intramuscular (IM) delivery, thus inducing an adaptive immune
response.
The preclinical work that supported this investigational new
drug application has been published online in Molecular Therapy
Nucleic Acids, a Cell Press partner journal. The paper
(https://www.cell.com/molecular-therapy-family/nucleic-acids/fulltext/S2162-2531(22)00287-6),
titled “Chimeric mRNA-based COVID-19 vaccine induces protective
immunity against Omicron and Delta variants,” will appear in print
in the December 2022 issue of the journal.
Sorrento plans to pursue more advanced mRNA vaccine strategies
in the future with the Sofusa MuVaxx lymphatic delivery system.
This proprietary microneedle system delivers vaccines intradermally
and, in animal models with an mRNA vaccine candidate, demonstrated
improved humoral immunity and superior cellular immunity with
1/10th of the IM dose. This preclinical work has been accepted for
publication by the Journal of Molecular Cell Biology (JMCB)
(https://academic.oup.com/jmcb/advance-article/doi/10.1093/jmcb/mjac041/6634240),
“Delivering an mRNA vaccine using a lymphatic drug delivery device
improves humoral and cellular immunity against SARS-CoV-2.” In
these preclinical studies using MuVaxx, immune responses were
elicited and maintained at a 10-fold dose reduction compared to
traditional IM administration as measured by anti-spike antibodies,
cytokine-producing CD8 T cells, neutralizing antibodies.
Remarkably, a 4-fold elevated T cell response was also observed in
MuVaxx administered vaccination compared to that of IM administered
vaccination. This microneedle system delivers the vaccine into
at the epidermal/dermal boundary and is virtually pain free. These
next generation advances may provide important alternative to the
vaccines in the U.S. and enable improved access globally in
countries like Mexico, Brazil, and China where mRNA-based vaccines
are not readily available.
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 next-generation tyrosine kinase inhibitors (“TKIs”),
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 STI-1557, STI-1558, COVISHIELD™, COVIDROPS™ and
COVI-MSC™; and diagnostic test solutions, including COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients
is also demonstrated by our effort to advance a 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 postherpetic
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 the development and prospects of STI-1557; the potential
for STI-1557 to have a cleaner safety profile; the potential use of
STI-1557 as an alternative to the vaccines in the U.S.; the
potential for STI-1557 to result in improved access to vaccines
globally, including in countries like Mexico, Brazil and China, the
potential of the mRNA-based next general platform to be adapted
rapidly to ever-emerging SARS-CoV-2 variants of concern and its
usefulness for other preventative, and therapeutic applications to
cancer, metabolic and autoimmune diseases; and Sorrento’s plans to
pursue more advanced mRNA vaccine strategies in the future. 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 safety and efficacy of STI-1557 and
seeking regulatory approval for STI-1557; clinical development
risks, including risks in the progress, timing, cost, and results
of clinical trials and product development programs; risks related
to Sorrento’s planned studies with STI-1557; 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, including those for STI-1557 and MuVaxx, may not be
replicated in continuing or 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 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
RelationsContact: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are
trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ (SP-102) is a trademark of Semnur
Pharmaceuticals, Inc. A proprietary name review by the FDA is
planned.
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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