Sorrento Therapeutics, Inc. (Nasdaq: SRNE,
"Sorrento") announced today updated
positive results from its Phase 1b study
of human allogeneic adipose-derived mesenchymal
stem cells (COVI-MSC™) for patients suffering
from COVID-19-induced acute respiratory distress
(ARD) or acute respiratory distress syndrome (ARDS).
This ongoing study (MSC-COV-101) is a single arm,
non-randomized Phase 1b study of the safety and preliminary
efficacy of COVI-MSCs administered every other day for
three infusions for a total of 1 x 106 cells/kg. The
primary objective of this study is to evaluate the safety
of intravenous infusion of allogeneic adipose MSC cells
in patients with COVID-19-induced ARD or ARDS.
Intensive care unit (ICU) patients with COVID-19-induced
respiratory failure, diffuse pulmonary infiltrates and evidence of
poor oxygenation: ratio of arterial partial pressure of oxygen to
fraction of inspired oxygen (PaO2/FiO2) ranging from an average of
135 to 225 (normal range ˃ 400) were enrolled. All nine patients
responded rapidly with markedly reduced need for high inspired
oxygen concentration and were able to be transferred out of the ICU
and discharged from the hospital within several days of their 3rd
COVI-MSC infusion. No infusion related safety events have been
reported. Dr. Eyad Almasri, Associate Professor of Medicine,
Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the
principal investigator in this ongoing study.
Currently, Sorrento is working with the FDA to plan a
placebo-controlled Phase 2 study to be conducted across multiple
sites in the United States, Brazil and Mexico, and to determine the
sample size and data necessary to support an emergency use
authorization (EUA).
Dr. Henry Ji, President and CEO of Sorrento Therapeutics,
stated, “It brings us great pleasure to see our treatments help to
save lives, which is our primary goal at Sorrento. We look forward
to advancing this important product into Phase 2 development.”
More information on the Phase 1 trial can be found
at www.clinicaltrials.gov (NCT04486001). Information
on the proposed Phase 2 trial is expected
to be available soon.
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. 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.
Personalized Stem Cells, Inc. (PSC) is Sorrento’s GMP
manufacturing partner for COVI-MSC.
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™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™,
Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions,
including COVITRACK™, COVISTIX™ and COVITRACE™.
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 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 potential efficacy of an adipose-derived
allogeneic MSC product candidate in patients with COVID-19 and in
respiratory distress; the clinical testing of an adipose-derived
allogeneic MSC product candidate; the preliminary results of the
Phase 1b trial to date; the continued enrollment and potential
commencement of any future clinical trials for an adipose-derived
allogeneic MSC product candidate; the ongoing plans to conduct a
Phase 2 study across multiple sites in the US, Brazil and Mexico;
the potential for preliminary data results to be replicated or
continue to show improved clinical safety or efficacy as the
ongoing trial continues; 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 technologies and prospects,
including, but not limited to risks related to seeking regulatory
approval for any adipose-derived allogeneic MSC product candidate;
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 therapeutic antibody
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, 2020, 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
ContactAlexis Nahama, DVM (SVP Corporate
Development)Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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