Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
today that it is filing an investigational new drug application
(IND) for intravenous (IV) COVI-AMG (STI-2020) to treat COVID-19
patients with mild symptoms and to evaluate safety and
pharmacokinetics in healthy volunteers.
Sorrento has previously submitted an IND for
COVI-GUARD™ (STI-1499), the parent antibody for COVI-AMG. That
submission was cleared by the FDA in September. Sorrento has built
on the knowledge from the prior IND requirements to file this new
IND, including information and data about Sorrento’s affinity
maturation process that further enhanced the potency of this
antibody.
As Sorrento previously announced, in preclinical
studies, STI-2020 demonstrated a 100% neutralizing effect (both in
vitro and in vivo) and at a very low dose prevented SARS-CoV-2 from
infecting healthy cells and causing COVID-19-like disease in golden
Syrian hamsters.
The high potency of the antibody may potentially
translate to more doses per bioreactor manufacturing run, lower
cost per dose, and allow for rapid deployment and availability to
patients. Sorrento has initiated cGMP manufacturing to produce
100,000 doses, expected to be available early next year, in
anticipation of a potential EUA.
In order to speed up development toward EUA
submission, Sorrento is also planning on initiating dosing in a
healthy population in order to rapidly generate safety and
pharmacokinetic results.
The STI-2020 antibody has been evaluated in
preclinical studies against multiple strains of SARS-CoV-2,
including the highly contagious D614G variant, the current dominant
strain globally.
The STI-2020 antibody has been engineered and
demonstrated in preclinical studies to avoid ADE
(antibody-dependent enhancement) which may be associated with the
serious side effects of some other neutralizing antibodies and
vaccines.
More information about the phase 1 clinical
trial can be found on www.clinicaltrials.gov (NCT#
NCT04584697).
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®"). Sorrento is also developing
potential antiviral therapies and vaccines against coronaviruses,
including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™ and COVI-DROPS™; and
diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ 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 SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, and to commercialize ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a phase IB trial for intractable pain associated with
cancer and a phase 1B trial in osteoarthritis patients.
SEMDEXA is in a pivotal Phase 3 trial for the treatment of
lumbosacral radicular pain, or sciatica. 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 neutralizing profile of STI-2020 and the
impact on SARS-CoV-2; the preclinical testing of STI-2020; the
safety, pharmacokinetics and efficacy of STI-2020; the potential
for STI-2020 to avoid antibody-dependent enhancement side effects;
the expectation of the commencement of any pivotal trials for
STI-2020; the potential receipt of an EUA for STI-2020 and expected
timing for any receipt thereof; the expected availability of doses
of STI-2020 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 potential
potency of STI-2020; the expected effective dose in humans; the
expected administration method of STI-2020; the potentially faster
manufacturing speed, availability and potential lower cost 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
pre-clinical studies and seeking IND regulatory approval for
STI-2020; conducting and receiving results of clinical trials for
STI-2020; the clinical and commercial success of STI-2020 against
preventing and treating SARS-CoV-2 virus infections; the viability
and success of 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 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-AMG™, COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™,
ACE-MABTM, COVI-DROPSTM, COVI-TRACK™, COVI-TRACE™, COVI-STIX™, and
COVI-MOBILE™ 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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