Sorrento Announces Its Lead Protein-Based COVID-19 Vaccine Candidate – DYAI-100 – Elicits Strong Neutralizing Immune Responses in Vaccinated Animals Against SARS-CoV-2 and Multiple Major Variants of Concern
August 19 2021 - 4:21PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical
and commercial stage biopharmaceutical company developing new
therapies to treat cancer, pain and COVID-19, released today a
preprint publication, which is accessible at:
https://www.biorxiv.org/content/10.1101/2021.08.17.456704v1.full.pdf.
The publication details preclinical vaccination studies of a new
to-be-licensed and developed protein-based COVID-19 vaccination
candidate, DYAI-100. The new RBD-based COVID-19 vaccination
candidate demonstrated in preclinical studies the potential to
elicit potent neutralizing B-cell immune responses against the
original SARS-CoV-2 strain and its emerging variants, including
Beta and Delta.
The generation of a protein-based vaccination
candidate that provides protection against the original SARS-CoV-2
virus and emerging VoCs has proved to be challenging. The
publication reports the protective neutralizing activities of the
sera of vaccinated animals against a broad spectrum of SARS-CoV-2
virus and its major VoCs by immunization with recombinant Spike
protein receptor binding domain (RBD) administered in conjunction
with aluminum-phosphate adjuvant intramuscularly. Immunizing mice
with RBD protein vaccine with simple aluminum-phosphate adjuvant
led to the production of IgG antibodies recognizing the Spike
protein of the prototype SARS-CoV-2 as well as the VoCs, such as
Alpha (“United Kingdom”), Beta (“South Africa”), Gamma
(“Brazil/Japan”), and Delta (“India”). RBD protein immunization
induced to the activation of a Th1 polarization of CD4 positive T
cells. Furthermore, RBD protein immunization produced IgG
antibodies in vivo, which exerted high neutralizing activity
against live SARS-CoV-2 and the highly transmissible VoCs, Beta and
Delta, as well as Gamma to a lesser extent. Thus, DYAI-100
represents a promising COVID-19 vaccination candidate against
COVID-19 that may potentially offer broad protective range against
emerging VOCs of SARS-CoV-2 virus.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
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”), 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 COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, 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 DYAI-100 and its properties, including its induction of
potent neutralization activity against SARS-CoV-2 and its variants
of concern, including Alpha, Beta, Gamma and Delta; the
collaboration between Sorrento and Dyadic, including but not
limited to, the development of DYAI-100 and completion of
IND-enabling studies for DYAI-100; the potential for DYAI-100 to
serve as a universal vaccine and as a universal booster for other
COVID-19 vaccines; the ability of an RBD protein-based vaccine,
including DYAI-100, to elicit strong immunity and produce IgG
antibodies against SARS-CoV-2 and its variants of concern when
administered intramuscularly in conjunction with an adjuvant,
including an aluminum-phosphate adjuvant; and Sorrento’s
expectation of obtaining licensing rights for DYAI-100 from Dyadic.
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
DYAI-100; 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™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, 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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