Sorrento Announces Selection of T-VIVA-19™ as Targeted Protein Vaccine Candidate for SARS-CoV-2
July 01 2020 - 12:06PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
today that it has published a pre-print publication
(https://www.biorxiv.org/content/10.1101/2020.06.29.178616v1.full.pdf)
describing initial pre-clinical results from its COVID-19
vaccination program, which introduced a novel targeted protein
vaccine against COVID-19, referred to as T-VIVA-19.
T-VIVA-19 is a recombinant fusion protein of the
spike protein S1-domain and the Fc portion of the human IgG1
antibody (rS1-Fc). The rS1-Fc was injected into either the vein or
the thigh muscle of a mouse. The mice were given a booster shot
three weeks later (by the same route as the initial injection) and
immune responses to SARS-CoV-2 were examined.
Immunization with the rS1-Fc protein via
intramuscular and intravenous injections induced antibodies against
the SARS-CoV-2 protein in all mice within the first week of
administration. Antibodies were observed to be enhanced upon the
administration of a booster. Approximately 80% of the mice’s sera
possessed neutralizing antibodies and completely prevented virus
infection in in vitro cell cultures using 100 TCID50 viruses and
VERO cells.
Dr. Henry Ji, Chairman and CEO of Sorrento
Therapeutics, said, “If successful and approved, we plan to produce
the T-VIVA-19 vaccine in our therapeutic antibody cGMP production
facility in San Diego. Due to the potentially low dose
administration of T-VIVA-19, which may be one milligram per person
or less, we believe our existing cGMP manufacturing facility is
capable of producing bulk drug substance rS1-Fc for up to 100
million doses a month. Unlike other vaccine candidates, our rS1-Fc
protein production could utilize our existing therapeutic antibody
manufacturing processes, and we therefore believe it would be
simple and easy to scale up.”
Sorrento plans to take the T-VIVA-19 vaccine
candidate through the regulatory steps for clinical trial
clearance, while preparing for large scale manufacturing and
commercial distribution in parallel.
About Sorrento Therapeutics,
Inc. Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat
cancers. 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™”, “Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™.
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 ZTlido® (lidocaine
topical system) 1.8% for the treatment of post-herpetic neuralgia.
RTX is completing a phase IB trial for intractable pain associated
with cancer and a phase 1B trial in osteoarthritis patients.
ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit
www.sorrentotherapeutics.com
Forward-Looking StatementsThis
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 Sorrento’s targeted protein
vaccine candidate, T-VIVA-19, and its potential use and benefit as
a vaccine against the SARS-CoV-2 virus; the pre-clinical testing of
T-VIVA-19; the potential administration, including route(s) of
administration and dosing regimen, and application(s) of T-VIVA-19;
the potential for T-VIVA-19 to generate neutralizing antibodies
after administration that are effective to prevent viral infection,
including the SARS-CoV-2 virus infection; the dosing potential of
T-VIVA-19; the expected readiness and manufacturing capabilities of
Sorrento’s cGMP facilities for large-scale production of T-VIVA-19;
the expected regulatory, development and commercialization path of
T-VIVA-19; T-VIVA-19’s ability to immunize against infection by
coronaviruses; and Sorrento’s potential position in the anti-viral
immunity 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 conducting pre-clinical studies and clinical trials and
seeking regulatory approval for T-VIVA-19; that prior test results
may not be replicated in future studies and trials; conducting and
receiving results of clinical trials for T-VIVA-19; the clinical
and commercial success of the vaccination program for SARS-CoV-2
virus infections using T-VIVA-19; the viability and success of
using T-VIVA-19 for prevention in anti-viral areas, including
coronaviruses; 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 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 T-VIVA-19 strategies; 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, 2019, 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.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARD™,
COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™,
COVI-TRACK™, Saving-Life™ and Improving-Life™ are trademarks of
Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals Inc.All other trademarks are the property of their
respective owners. © 2020 Sorrento Therapeutics, Inc. All
Rights Reserved.
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