Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical
and commercial stage biopharmaceutical company developing new
therapies to treat cancer, pain (non-opioid treatments), autoimmune
disease and COVID-19, today announced promising preclinical results
for its mRNA vaccine against SARS-CoV-2. STI-mRNA is comprised of
proprietary designer Spike-encoding mRNAs to elicit cellular and
humoral immunity against the early WA-1 virus as well as the
predominant and emerging variants of concern (VOCs), including
Alpha, Beta, Gamma, Delta, and Lambda.
Currently marketed vaccines have demonstrated
reduced efficacy against the major SARS-CoV-2 emerging VOCs2, with
declining efficacy over time3. Novel approaches are needed that
improve durability for both humoral and cellular immunity against
current and emerging variants.
The MuVaxx lymphatic drug delivery device is designed to deliver
vaccine into the epidermis to potentially enable access and
increased exposure to dendritic (antigen-presenting) cells in the
skin and in lymph nodes at lower doses than with intramuscular
administration. Initial preclinical results are summarized below,
and complete results are accessible at:
https://www.biorxiv.org/content/10.1101/2021.08.25.457699v1
- Intramuscular
(IM) STI-mRNA (10µg) compared to the IM LNP-mRNA (10µg) showed a
dramatic 400% improvement in cellular immunity as measured by
cytokine production of spike specific CD8 T cells.
- This elevated
level of cellular immune response was also observed at 1/10th of
the STI-mRNA dose using the MuVaxx lymphatic drug delivery
device.
- STI-mRNA
(1/10th dose delivered with MuVaxx) also demonstrated similar
humoral immunity (anti-RBD IgG and anti-S1 IgG antibodies) as
compared to the IM LNP-mRNA reference (10µg) and IM STI-mRNA
(10µg).
These preclinical findings are significant as
cellular immunity is critical for impeding virus replication and
conferring long-term protection. Additionally, current approved
LNP-mRNA vaccines have been shown to potentially have
dose-dependent side effects4. The STI-mRNA and MuVaxx combination
appear to elicit a similar humoral response and an elevated
cellular response against the SARS-CoV-2 virus, at a fraction of
the current vaccine doses. These initial preclinical results
provide the basis for Sorrento to move forward aggressively with
IND-enabling studies with our MultiValent STI-mRNA vaccine
candidate.
References
1. LNP mRNA Reference Standard – This reference
standard used is a similar construct as to LNP mRNAs used in
current EUA authorized vaccines.
2. J. L. Bernal, N. Andrews, et.al.,
“Effectiveness of COVID-19 Vaccines against the B.1.617.2 (Delta)
Variant”; The New England Journal of Medicine; 2021;
385:585-594.
3. S. J. Thomas, E. D. Moreira, et.al., “Six
Month Safety and Efficacy of BNT1626b2 mRNA COVID-19 Vaccine;
medRxiv Preprint; 101/2021.07.28.21261159
4. Jackson, et. al., “An mRNA Vaccine against
SARS-CoV-2”, The New England Journal of Medicine,
2020;383:1920-31
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, COVIGUARD™, COVI-AMG™,
COVISHIELD™, 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 expectations for Sorrento's technologies and product
candidates, including, but, not limited to, Sorrento’s STI-mRNA
vaccine program, including its STI-mRNA vaccine candidate delivered
with the MuVaxx Lymphatic Drug Delivery Device; the potential
effectiveness of STI-mRNA administered intramuscularly with the
MuVaxx device against the WA-1 virus and variants of concern,
including the Alpha, Beta, Gamma, Delta and Lambda variants; the
potential that administering STI-mRNA intramuscularly with the
MuVaxx device at a reduced dosage, including 1/10th of the standard
dose, will result in an improvement in cellular immunity and/or
similar humoral immunity compared to the current LNP-mRNA reference
standard (10µg); the potential for STI-mRNA administered
intramuscularly with the MuVaxx device to result in reduced
dose-dependent side effects compared to current approved LNP-mRNA
vaccines; Sorrento’s plans and expected timing for completing
IND-enabling studies for STI-mRNA; 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 technologies
and prospects, including, but not limited to risks related to
conducting preclinical and IND-enabling studies, and seeking IND
regulatory approval for STI-mRNA; conducting and receiving results
of clinical trials for STI-mRNA; the clinical and commercial
success of STI-mRNA against preventing COVID-19; 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 therapeutic antibody product candidate
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
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™, MuVAXX™, COVIGUARD™,
COVI-AMG™, COVISHIELD™, 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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