Sorrento Therapeutics and ViralClear Enter Into Agreement to Explore Combination Antibody Plus Antiviral Therapy Against COVI...
September 30 2020 - 9:00AM
ViralClear Pharmaceuticals, Inc. (Nasdaq BSGM) and Sorrento
Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced the
companies are exploring the synergistic potential of small
molecules and antibodies combination therapies against COVID-19.
In general, multi-modal approaches are
considered the most likely to succeed anti-viral strategies. Even
with highly effective stand-alone therapies, a synergistic
combination can be pursued to help reduce the effective dose needed
of each individual agent and aim to ensure maximum effect.
The agreement between ViralClear Pharmaceuticals, Inc. (Parent
company BioSig Technologies, Inc. Nasdaq:BSGM) and Sorrento
Therapeutics will allow for testing of merimepodib with
neutralizing antibodies in the Golden Syrian hamster model of
COVID-19.
The study will look for synergy at the effective doses between
the two drugs already in human clinical trials and will try to
specifically demonstrate that the combined benefits in
strengthening and accelerating viral clearance exceed what each
drug could deliver by itself.
Pending the outcome of these studies, the results might be
presented to the FDA to support the initiation of a human clinical
trial of the drug combination.
About ViralClear Pharmaceuticals and
Merimepodib BioSig’s Technologies, Inc (Nasdaq:
BSGM www.biosig.com) subsidiary, ViralClear Pharmaceuticals,
Inc. (ViralClear), is seeking to develop a novel pharmaceutical
called merimepodib to treat patients with COVID-19. Merimepodib is
intended to be orally administered, and has demonstrated
broad-spectrum in vitro antiviral activity, including strong
activity against SARS-CoV-2 in cell cultures. Merimepodib was
previously in development as a treatment for chronic hepatitis C
and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with
12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400
subjects and patients and an extensive preclinical safety package
was completed. A manuscript titled, “The IMPDH inhibitor
merimepodib provided in combination with the adenosine analogue
Remdesivir reduces SARS-CoV-2 replication to undetectable levels in
vitro”, was submitted to an online peer-reviewed life sciences
journal. This manuscript is authored by Natalya Bukreyeva, Rachel
A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and
Slobodan Paessler of the UTMB Galveston National Laboratory and Dr.
Jerome Zeldis of ViralClear as a corresponding author. This article
highlights pre-clinical data generated under contract with
Galveston National Laboratory at The University of Texas Medical
Branch.
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™ 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-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™ 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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