Sorrento Releases Preclinical Data for STI-1499 (COVI-Guard™) and STI-2020 (COVI-AMG™), Potent Neutralizing Antibodies Ag...
September 28 2020 - 11:59PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) released
preclinical data reporting on COVI-GUARD™ (STI-1499) and COVI-AMG™
(STI-2020;
Affinity
Matured
COVI-
Guard) neutralizing antibodies (nAbs) against
SARS-CoV-2 as well as a D614G virus variant infection in a preprint
publication, which can be found at
{https://biorxiv.org/cgi/content/short/2020.09.27.316174v1}. Both
STI-1499 and STI-2020 demonstrated potent neutralizing activities
against SARS-CoV-2 virus infection in preclinical models. STI-1499
nAb has been cleared by the FDA for a Phase 1 clinical trial in
hospitalized COVID-19 patients. STI-2020 is an affinity-matured
version of the COVI-GUARD nAb and has demonstrated a greater than
50-fold increase in potency in in vitro experiments.
In preclinical cell-based assay, both STI-1499
and STI-2020 have shown 100% in vitro neutralization of SARS-CoV-2
at concentrations of 6 µg/ml and 78 ng/ml, respectively. The
neutralization activity at these concentrations protected against
both SARS-CoV-2 and the highly contagious Spike D614G isolate.
Dr. Slobodan Paessler’s laboratory at the
University of Texas Medical Branch at Galveston (UTMB) has
generated promising preclinical animal data for STI-1499 and
STI-2020 nAbs in a Syrian golden hamster model infected with
SARS-CoV-2. A few highlights of the data from the most recent
STI-2020 study:
- Hamsters infected with SARS-CoV-2
and then treated with a single dose of 500 µg STI-2020 started
gaining weight within 48 hours of STI-2020 administration, as
compared to control animals that steadily lost weight for 5 days
before recovery.
- At day 5, STI-2020-treated (500 µg)
hamsters had gained 5% weight, versus a weight loss of about 10%
for the control animals (15% difference).
- At day 5, all STI-2020-treated (500
µg) hamsters (5 out of 5 analyzed animals) had undetectable virus
load in lungs as compared to the lungs of animals in the control
group, where more than 1,000 infectious viral particles per gram of
tissue were readily detected.
Based on interspecies allometric scaling
methods, the 500 µg single dose of STI-2020 administered to the
hamsters in the preclinical studies would be equivalent to a human
dose of less than 100 mg of antibody
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804402/). In
contrast to other currently-used dosing regimens requiring grams of
antibody per patient for treating COVID-19, this antibody could be
highly potent at a very low dose. COVI-AMG could therefore
potentially be administered as a simple and rapid injection to
treat COVID-19 patients.
“We believe that the results for STI-1499 and
STI-2020 are truly remarkable. Based on the preclinical testing we
have conducted to date, STI-2020 is our most promising SARS-CoV-2
antibody so far. The potency of both nAbs and their ability to
mitigate SARS-CoV-2 infection from the lungs in a Syrian golden
hamster model is very impressive, strongly supporting further
development of these antibodies,” stated Dr. Henry Ji, Chairman and
CEO of Sorrento. “STI-1499 has been cleared by the FDA for a Phase
1 clinical trial in hospitalized COVID-19 patients. STI-2020 has
the potential to be utilized for both early and late therapeutic
interventions, as well as for prophylaxis, with the potential of
having a low efficacious dose, which could enable efficient
manufacturing and ultimately result in higher affordability for
patients.”
Sorrento has received FDA clearance for its
Phase 1 clinical trial for STI-1499 in hospitalized COVID-19
patients and intends to submit an IND for STI-2020 as soon as
possible.
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™, COVI-STIX™, COVI-TRACE™ and
COVI-AMG™.
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 has completed a phase 1B 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
the potency and potential blocking capabilities of STI-1499 and
STI-2020 and the impact on SARS-CoV-2; the preclinical testing of
STI-1499 and STI-2020; the safety and efficacy of STI-1499 and
STI-2020; the expectation of the commencement of any pivotal trials
for STI-1499 and STI-2020; the predictive value of the animal model
used in preclinical studies; the human equivalent dose of STI-1499
and STI-2020 that may be required; the expected method of
administration of STI-2020 and the expected dosage amount and rate
thereof; the potential applications for STI-1499 and STI-2020; the
potential of having a low efficacious dose; the potentially faster
or efficient manufacturing speed, availability and potential lower
cost for STI-2020; the strategic prioritization of an IND
submission for STI-2020; 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 preclinical studies and seeking IND
regulatory approval for STI-2020; conducting and receiving results
of clinical trials for STI-1499 and STI-2020; the clinical and
commercial success of STI-1499 and STI-2020 against preventing and
treating SARS-CoV-2 virus infections; the viability and success of
STI-1499 and STI-2020 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 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 the company in the execution of its COVID-19 therapeutic
product candidates 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.
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-GUARDTM,
COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MABTM,
COVI-TRACK™, COVI-STIX™, COVI-TRACE™ and COVI-AMG™ 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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