Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced
today that it has entered into an exclusive license agreement with
Personalized Stem Cells, Inc. (PSC) to acquire global rights to its
adipose derived mesenchymal stem cells (MSCs) for patients
suffering from acute respiratory distress syndrome (ARDS)
associated with COVID-19, which have been cleared for a Phase 1
clinical trial by the FDA.
The study is a single arm, non-randomized Phase
1 study of the safety and preliminary efficacy of an
adipose-derived allogeneic MSC product candidate. The outcome data
will be compared to contemporaneous non-enrolled patients at the
same clinical site(s) as the enrolled patients. The primary
objective is to evaluate the safety of intravenous infusion of
allogeneic adipose stem cells in patients with COVID-19 and in
respiratory distress. The secondary objective is to evaluate a set
of safety and efficacy outcome variables to give guidance regarding
the risk/benefit ratio in patients with COVID-19 respiratory
distress.
More information on the Phase 1 trial can be found at:
https://clinicaltrials.gov/ct2/show/NCT04486001?term=coronastem&draw=2&rank=1
Sorrento will be assuming responsibility for
executing the Phase 1 trial, which is targeted to enroll about 20
hospitalized COVID-19 patients in California. Pending the results
of the Phase 1 trial, Sorrento expects to expand into Phase 2
trials in multiple relevant geographies as may be determined in
consultation with applicable regulatory authorities.
Stem cells have been demonstrated to support
resolution of symptoms in multiple disease settings and have the
potential to reduce the long-term effects associated with pulmonary
tissue damage for these patients. More information on the potential
use and benefits of MSCs for patients with COVID-19 can be found in
the recently published review at:
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2
Stem cells represent a treatment modality with
high potential to help in the fight against COVID-19 as a
stand-alone therapy or in synergy with other product candidates in
Sorrento’s pipeline, including small molecules (abivertinib or
salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).
Until a time where early treatments are more
readily available, it is important to provide patients severely
afflicted with COVID-19 multimodal solutions that can help increase
survival, reduce the time spent in the hospital and reduce
long-term sequelae. The long-term lingering effects of COVID-19 on
the body can persist for months after patients leave the hospital,
especially for patients that received ventilator support. Shortness
of breath, difficulty doing simple tasks and pulmonary fibrosis are
among the common complaints of long-term effects of the disease on
COVID-19 patients leaving the ICU.
Dr. Robert Harman, CEO of PSC stated, “We are
delighted to be working with a company such as Sorrento, that has
the vision and expertise to take our program through the next steps
in the clinical development process. Sorrento saw the translational
value of our decades of work in animal health and has acknowledged
the extensive manufacturing and regulatory work we have done in
bringing human cell lines to a Phase 1 FDA clearance. We are
looking forward to collaborating on this initiative and
beyond.”
Dr. Henry Ji, Chairman and CEO of Sorrento
stated, “Stem cells were a missing piece in our comprehensive
portfolio of potential solutions against COVID-19. We now cover
multiple stages of the continuum of care from prevention to
potential therapeutic solutions for the most advanced stages of the
disease. With PSC’s Phase 1 product candidate, we hope to move
quickly through the next clinical trials, and, if successful, be
able to provide a supportive therapy that may save the lives of the
most advanced patients and may also ensure patients who have to
undergo intensive care can benefit from a therapy with the
potential to minimize the long-term effects of the disease due to
the lung damage created by the virus early in the infection.”
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
and COVID-19. 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 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 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 Statements
This 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 safety and efficacy of an adipose-derived allogeneic
MSC product in patients with COVID-19 and in respiratory distress;
the clinical testing of an adipose-derived allogeneic MSC product;
the expected enrollment of the Phase 1 trial; the potential
commencement of any future clinical trials for an adipose-derived
allogeneic MSC product; the ability of an adipose-derived
allogeneic MSC product to work as a stand-alone therapy or in
synergy with our other product candidates; the ability of an
adipose-derived allogeneic MSC product to support healing and
reduce the long-term effects associated with pulmonary tissue
damage for COVID-19 patients; our ability to provide a supportive
therapy for COVID-19 patents using an adipose-derived allogeneic
MSC product; the ability of an adipose-derived allogeneic MSC
product to potentially save lives of COVID-19 patients and to
potentially minimize the long-term effects of COVID-19; our ability
to cover all stages of the continuum of care for COVID-19; and our
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 seeking
regulatory approval for any adipose-derived allogeneic MSC product;
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 Sorrento in the execution of its COVID-19 therapeutic
product candidate 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.
Media and Investor Relations
Contact: Alexis Nahama, DVM (SVP Corporate Development)
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARDTM,
COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™,
ACE-MAB™, 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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