SAN DIEGO, July 29, 2020 /PRNewswire/ -- Sorrento
Therapeutics, Inc. (Nasdaq: SRNE) ("Sorrento") today announced it
has entered into a licensing agreement with Columbia University ("Columbia") for the rights to
a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in
as little as 30 minutes from a sample of saliva. Unlike other
commercially available diagnostic products, the test developed by
Columbia's team, to be marketed by Sorrento under the COVI-TRACE™
name, holds all of the testing materials in a single tube and
requires no specialized laboratory equipment, making it easily
deployable for point of care, on-site or potentially at-home
testing.
Current diagnostic tests for SARS-CoV-2 detect viral ribonucleic
acid (RNA) but must be shipped to a reference laboratory unless the
facility collecting the samples has purchased costly
instrumentation, cartridges and consumables to extract viral RNA
from the fluid in which the sample — either a nasopharyngeal swab
or saliva — is placed. The current backlog in SARS-CoV-2 testing
has resulted in average turnaround times of between several days to
over a week, and laboratories across the country are reportedly
struggling to keep up with increased testing demand.
Developed by Zev Williams, MD,
PhD, and his team at the Columbia
University Fertility Center, the COVI-TRACE approach
eliminates the extraction step and simplifies overall sample
processing. A small sample of saliva is collected in a cup and then
placed into a tube containing enzymes and reagents that can detect
the SARS-CoV-2 virus's RNA. The tube is then placed into a simple
heat block or water bath to keep the sample warm throughout the
chemical reaction, which takes 30 minutes or less to provide a
colorimetric reading based on detection of the presence of the
virus.
Preliminary study results were published in a paper by Williams
and colleagues at Columbia University
Irving Medical Center titled, "Field-deployable, rapid and direct
diagnostic testing of saliva samples for SARS-CoV-2," in MedRxiv on
June 16, 2020. The study evaluated
the new test in 60 samples, including 30 samples with virus and 30
without. The study found sensitivity and specificity of 97% and
100%, respectively, and the ability to detect as few as 1 or 2
copies of the SARS-CoV-2 virus in a microliter of saliva.
Dr. Zev Williams, Director of the
Columbia University Fertility Center,
stated, "Testing for SARS-CoV-2 needs to be fast, frequent, and
far-reaching. We are delighted to work with Sorrento Therapeutics
in the hope that COVI-TRACE may be scaled and deployed in the U.S.
and around the world to combat the spread of COVID-19."
Dr. Henry Ji, Chairman and CEO of
Sorrento Therapeutics, Inc., stated, "We are building a portfolio
of highly relevant COVID-19 solutions that spans diagnostics,
prevention, early intervention and rescue therapies. COVI-TRACE
will be a key asset in our diagnostic solutions, and we intend to
move rapidly to submit an emergency use authorization request to
the FDA and prepare for full-scale production. Such a simple,
deployable and cost-effective solution, in synergy with our
potentially neutralizing antibodies, could become the 'economy
opener' our country has been waiting for."
Reading test results is designed to be simple (Figure 1): If the
fluid in the tube turns yellow, the test is considered positive
(virus RNA present), and if the fluid turns red, the test is
considered negative (no virus RNA present).
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™; and diagnostic test
solutions, including COVI-TRACK™ and COVI-TRACE™.
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 potential deployment points
for COVI-TRACE; COVI-TRACE's ability to detect the SARS-CoV-2
virus; the receipt of emergency use authorization (EUA) approval
for COVI-TRACE; the expected regulatory, development and
commercialization path for COVI-TRACE; the readiness of Sorrento
for full-scale production of COVI-TRACE; the cost-effectiveness of
COVI-TRACE; the neutralizing effects of Sorrento's antibodies; the
impact that Sorrento's products and product candidates may have on
the U.S. economy; Sorrento's pipeline of product candidates for the
potential detection, vaccination and treatment of COVID-19; 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 seeking
EUA regulatory approval for COVI-TRACE; the clinical and commercial
success of the detection of the SARS-CoV-2 virus infections using
COVI-TRACE; the viability and success of using COVI-TRACE for
detection of the SARS-CoV-2 virus; 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
COVI-TRACE 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, 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.
Media and Investor Relations
Contact: Dani Frank
Email: sorrentotherapeutics@factorypr.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™, COVI-TRACE™, 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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SOURCE Sorrento Therapeutics, Inc.