SAN DIEGO, May 15, 2020 /PRNewswire/ -- Sorrento
Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today that
its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100%
inhibition of SARS-CoV-2 virus infection in an in
vitro virus infection experiment at a very low antibody
concentration.
As recently announced, Sorrento aims to generate an antibody
cocktail product that would act as a "protective shield" against
SARS-CoV-2 coronavirus infection and remain effective even if virus
mutations render a single antibody therapy less effective over
time.
Sorrento has been diligently screening billions of antibodies in
its proprietary G-MAB™ fully human antibody library
and has so far identified hundreds of antibody candidates that bind
the S1 subunit of the SARS-CoV-2 Spike protein. Approximately one
dozen of these antibodies have demonstrated the ability to block
the S1 protein's interaction with human angiotensin-converting
enzyme 2 (ACE2), the receptor used for viral entrance into human
cells. These blocking antibodies were further tested for their
ability to inhibit SARS-CoV-2 virus infection in an in vitro
SARS-CoV-2 virus infection model pursuant to a preclinical testing
agreement for COVID-19 therapeutic candidates that was previously
announced on March 31, 2020 (Sorrento
Therapeutics).
Among the antibodies showing neutralizing activity, one antibody
stood out for its ability to completely block SARS-CoV-2 infection
of healthy cells in the experiments. STI-1499 completely
neutralized the virus infectivity at a very low antibody dose,
making it a prime candidate for further testing and development.
Initial biochemical and biophysical analyses also indicate STI-1499
is a potentially strong antibody drug candidate.
Sorrento has determined STI-1499 will likely be the first
antibody in the antibody cocktail (COVI-SHIELD™) it is
developing, as recently announced. STI-1499 is also expected to be
developed as a stand-alone therapy, (COVI-GUARD™)
because of the high potency it has exhibited in experiments to
date. Sorrento plans to request priority evaluation and accelerated
review from regulators to determine the best pathway to make any
potential treatment available as soon as possible. Sorrento's
existing state-of-the-art cGMP antibody manufacturing facility in
San Diego is expected to be able
to produce up to two hundred thousand doses per month and the
Company intends to produce a million doses at risk while seeking
FDA approval for any STI-1499 product candidate. The Company is
seeking potential government support and pharmaceutical partners to
further scale up STI-1499 manufacturing capacity with a goal of
potentially providing tens of millions of doses in a short period
of time to meet the vast projected demand.
"Our STI-1499 antibody shows exceptional therapeutic potential
and could potentially save lives following receipt of necessary
regulatory approvals. We at Sorrento are working day and night to
complete the steps necessary to get this product candidate approved
and available to the waiting public," stated Dr. Henry Ji, Chairman and CEO of Sorrento.
About Sorrento Therapeutics, Inc.
Sorrento is a
clinical stage, antibody-centric, biopharmaceutical company
developing new therapies to turn malignant cancers into manageable
and possibly curable diseases. 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 coronavirus
antiviral therapies and vaccines, including COVIDTRAP™,
ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™ and
COVI-CELL™. 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 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 potency and potential blocking capabilities of
STI-1499 and the impact on SARS-CoV-2, the SARS-CoV-2 Spike protein
and viral entry; the expected length of any antiviral protection
provided by STI-1499; the potential administration and applications
of STI-1499; the potential for STI-1499 to protect against future
mutations of coronavirus; the preclinical testing of STI-1499; the
safety and efficacy of STI-1499; the readiness of Sorrento's cGMP
facilities for large-scale production of STI-1499 for
commercialization and Sorrento's expected capacity to produce drug
substance; the expected time needed for Sorrento's cGMP facilities
to produce doses of STI-1499; the potential inclusion of STI-1499
in the antibody cocktail (COVI-SHIELD™) that Sorrento is developing
and its development as a stand-alone therapy; the therapeutic
potential of STI-1499 for SARS-CoV-2 and COVID-19 disease and any
potential ability to save lives; 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 conducting pre-clinical studies and seeking IND
regulatory approval for STI-1499; conducting and receiving results
of clinical trials for STI-1499; the clinical and commercial
success of STI-1499 against preventing and treating SARS-CoV-2
virus infections; the viability and success of STI-1499 in
anti-viral therapeutic 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 the company in the execution of its COVID-19
therapeutic product candidates strategies; risks related to
Sorrento's debt obligations; 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, 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.
Contact
Eef Vicca,
Factory PR
Email: sorrento@factorypr.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
G-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™,
COVIDTRAP™, ACE-MAB™ and
COVI-CELL™ are trademarks of Sorrento Therapeutics,
Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
Seprehvir®, is a registered trademark of Virttu Biologics
Limited, a wholly owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics,
Inc.
All other trademarks are the property of their respective
owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/sti-1499-a-potent-anti-sars-cov-2-antibody-demonstrates-ability-to-completely-inhibit-in-vitro-virus-infection-in-preclinical-studies-301059779.html
SOURCE Sorrento Therapeutics, Inc.