Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in C...
September 16 2020 - 9:30PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
today that it received a study may proceed letter from the FDA for
its phase 1 clinical trial for COVI-GUARD (STI-1499) in
hospitalized COVID-19 patients.
As Sorrento previously announced, in preclinical
studies, STI-1499 demonstrated 100% in vitro neutralizing effect
against SARS-CoV-2, preventing infection of healthy cells in such
preclinical in vitro studies.
STI-1499 was further evaluated in preclinical
studies using multiple strains of SARS-CoV-2, including the highly
contagious D614G variant. In these preclinical studies, the
antibody has been 100% effective against the highly contagious
D614G variant strain at similar doses to those observed in
experiments with the USA-WA1/2020 strain.
Animal data generated in Syrian Golden hamsters
infected with SARS-CoV-2 was presented to the FDA in support of a
post-exposure human treatment dose for the IND. The effective dose
in the hamster model translates to a projected total dose of
approximately 160mg for a human patient.
The highest proposed dose (200 mg per patient)
in the phase 1 trial is a lower dose than currently being tested
for other known SARS-CoV-2 targeted antibodies or antibody
cocktails in active clinical studies. The potentially high potency
of STI-1499 antibody may allow for rapid scaling up of
manufacturing operations.
The STI-1499 clinical program is being designed
for rapid adaptive expansion, including international sites in
Brazil to supplement the US program.
More information about the phase 1 clinical
trial can be found on www.clinicaltrials.gov (NCT# 04454398).
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 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 the
impact on SARS-CoV-2; the clinical testing of STI-1499; the safety
and efficacy of STI-1499; the expected speed and timing for
enrolling patients in the phase 1 trial; the expectation of the
commencement of any pivotal trials for STI-1499; the potential
commencement and size of any future clinical trials for STI-1499;
the expectation that the STI-1499 clinical program will be designed
for rapid adaptive expansion in the United States and
internationally; the expected timing of any EUA submission; the
potential receipt of an EUA for STI-1499 and expected timing for
any receipt thereof; the expected availability of doses of STI-1499
and the timing thereof; the predictive value of the animal model
used in preclinical studies; the proposed dosages in the phase 1
clinical trial and any future clinical trials; the potential for
rapid scaling up of manufacturing operations for STI-1499; 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 and 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 that prior
test 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™, and COVI-TRACE™ 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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