Sorrento Announces That Intranasal Administration of COVI-AMG™ Neutralizing Antibody Prevented COVID-19 Disease Progression...
October 29 2020 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) previously
released preclinical data about intravenous COVI-AMG™ (STI-2020;
Affinity
Matured
COVI-
GUARD) neutralizing antibody (nAb) in a
preprint publication, which can be found at
{https://biorxiv.org/cgi/content/short/2020.09.27.316174v1}. Today,
Sorrento announced the enhancement of the clinical potential of
this antibody by releasing in vivo data of
intranasal COVI-DROPS (STI-2099) in a new preprint
publication, which can be found at {https://www.biorxiv.org/}.
Preclinical animal data generated at Dr.
Slobodan Paessler’s laboratory at the University of Texas Medical
Branch (UTMB) at Galveston in Syrian Golden hamsters infected with
SARS-CoV-2 has demonstrated the following encouraging results:
- Hamsters were infected with 5x104
median tissue culture infectious dose (TCID50) intranasally.
Following infection, animals were rested for 12 hours. At that
time, animals were administered a 500 ug dose of COVI-AMG nAb by
either the intravenous (IV) or the intranasal (IN) route. Control
animals were administered an isotype control antibody using the
same IN and IV regimens.
- Intravenously-dosed animals
recovered from the infection with noticeable differences in weight
loss between the Control IgG and COVI-AMG-treatment groups reaching
a maximum at Day-5 after infection. Remarkably,
intranasally-COVI-DROPS-treated animals showed evidence, as early
as Day-2 into the experiment, of prevention of disease progression
with limited weight loss in the very early stages of infection and
reduced duration of disease symptoms as compared to COVI-AMG
IV-treated animals.
“The simplicity of COVI-DROPS, an
intranasal administration of an extremely potent neutralizing
antibody against COVID-19 would permit timely and massive access to
much needed antiviral treatments. We at Sorrento are optimistic
that if these findings in the COVID-19 hamster model of infection
are replicated in patients with COVID-19 in planned clinical
trials, we could be in a position to potentially open up society by
preventing virus proliferation and spread, and potentially reduce
or prevent hospitalizations or even hospital visits” stated Dr.
Henry Ji, Chairman and CEO of Sorrento.
Based on interspecies allometric scaling
methods, the 500 µg single dose of STI-2020 (IV) or STI-2099
COVI-DROPS (IN) administered to the hamsters in the preclinical
studies would be equivalent to a human dose of approximately 45 mg
of antibody
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804402/). Sorrento
plans to investigate the intranasal formulation of COVI-DROPS
STI-2099 in patients recently testing positive for COVID-19 as
simple intranasal drops.
An image accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/065aabda-6b7e-4574-a4ba-50bf427c1004
As illustrated, current neutralization antibodies (or antibody
cocktails) known to be in development or under FDA EUA approval
review are administered in large amounts (often in grams) that
require infusions over hours in a hospital setting (Figure
1A). Sorrento’s intravenous COVI-AMG nAb (STI-2020) may
require only an intravenous slow push due to the high potency
demonstrated in animal models to date (Figure 1B).
Furthermore, intranasal COVI-DROPS (STI-2099) may be able to be
administered as simple intranasal drops
(Figure 1C),
which would avoid the need for IV infusion or injection and a
hospital visit for treatment.
Sorrento is in the final stages of cGMP
manufacture of both forms of the antibodies and anticipates
submitting IND filings for both intravenous STI-2020 and intranasal
COVI-DROPS STI-2099 in November 2020. Sorrento intends to initiate
studies in healthy volunteers to establish pharmacokinetics and
safety, while also initiating studies in newly infected COVID-19
patients to demonstrate safety and reduction of virus load and
COVID-19 symptoms.
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™, COVI-AMG™ 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 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-2020 and
STI-2099 and the impact on SARS-CoV-2; the preclinical testing of
STI-2020 and STI-2099; the safety and efficacy of STI-2020 and
STI-2099; the expectation of the commencement of any clinical
trials for STI-2020 and STI-2099; the potential trial design for
STI-2020 and STI-2099; the predictive value of the animal model
used in preclinical studies; the human equivalent dose of STI-2020
or STI-2099 that may be required; the potential applications for
STI-2020 and STI-2099; the potential of having a low efficacious
dose; the potentially faster or efficient manufacturing speed,
availability and potential lower cost for STI-2020 and STI-2099;
the expected methods of administration of STI-2020 and STI-2099;
the expected timing for submitting IND filings for STI-2020 and
STI-2099; 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 and STI-2099; conducting and receiving results of clinical
trials for STI-2020 and STI-2099; the clinical and commercial
success of STI-2020 and STI-2099 against preventing and treating
SARS-CoV-2 virus infections; the viability and success of STI-2020
and STI-2099 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-GUARD™,
COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™,
ACE-MAB™, COVI-DROPS, COVI-TRACK™, COVI-STIX™ 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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