Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2
August 19 2020 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
that it is filing an investigational new drug application (IND) for
COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today.
Sorrento has previously received guidance from
the FDA in response to a pre-IND meeting package and believes it
has addressed all questions and followed the recommendations from
the agency for all sections of the IND.
As Sorrento previously announced, in preclinical
studies, STI-1499 demonstrated 100% neutralizing effect (in vitro)
of the antibody and that a low dose prevented SARS-CoV-2 from
infecting healthy cells in such preclinical in vitro studies.
Animal data generated by Dr. Paessler’s
laboratory at the University of Texas Medical Branch at Galveston
(UTMB) in Syrian Golden Hamsters infected with SARS-CoV-2, justify
the IND filing and continued clinical development. This established
model, while limited, is the most predictive animal model currently
available for this disease. The data were presented to federal
agencies and will be published as soon as possible in a scientific
journal.
The highest proposed dose (200 mg per patient)
in the phase 1 safety trial is a much lower dose than currently
being tested for other known antibodies in active clinical studies.
The potentially higher potency of the antibody may allow for faster
scaled manufacturing (availability to patients) and potentially a
lower cost per dose as compared to other known antibodies currently
being evaluated.
STI-1499 antibody has also been evaluated in
preclinical studies against multiple strains of SARS-CoV-2,
including the highly contagious D614G mutant, the current dominant
strain globally. In such preclinical studies, the antibody has been
100% effective against the highly contagious D614G mutant strain at
a low dose.
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 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 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 preclinical testing of STI-1499; the
safety and efficacy of STI-1499; the expectation of the
commencement of any pivotal trials for STI-1499; 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 belief that the IND addresses all questions and
recommendations from the FDA; the predictive value of the animal
model used in preclinical studies; the proposed dosages in the
phase 1 clinical trial; the potentially faster manufacturing speed,
availability and potential lower cost 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
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 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-GUARD™,
COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™,
COVI-TRACK™, COVI-TRACE™, COVI-MOBILE™, 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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