SAN DIEGO, July 20, 2020 /PRNewswire/ -- Sorrento
Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today received
clearance from the FDA to initiate a Phase 2 trial of Abivertinib
in patients with COVID-19 who have moderate to severe pulmonary
symptoms.
Abivertinib is a novel small molecule tyrosine kinase inhibitor
(TKI) that selectively targets both mutant forms of the epidermal
growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK).
On May 21, 2020, Sorrento
announced that it had entered into a binding term sheet for an
exclusive license to ACEA Therapeutics' Abivertinib across all
indications for all territories outside of China. The parties
have since entered into an exclusive license agreement.
Abivertinib irreversibly binds to the BTK receptor, preventing
the phosphorylation of the receptor. Due to this effect, it
has shown potent immunomodulatory activities in vitro by inhibiting
key pro-inflammatory cytokine production, including IL-1beta, IL-6
and TNF-alpha. These cytokines are associated with cytokine release
syndrome (CRS) or cytokine storm and COVID-19 disease progression
with poor outcomes in patients with acute respiratory distress
syndrome (ARDS).
Since Abivertinib targets multiple cytokines simultaneously,
Sorrento anticipates that the effects of Abivertinib will be
incremental to the initial published findings by others for IL-6
inhibitors targeted for COVID-19 trials, and the clinical benefits
will be more pronounced given the broader range of anti-cytokine
activity.
The trial, titled A Phase 2, Double Blinded, Randomized Study of
the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With
Standard of Care Versus Standard of Care in Subjects Hospitalized
With COVID-19 (NCT04440007), will be initially conducted in centers
in the USA.
Abivertinib has been studied in over 600 patients worldwide in
various oncologic indications, including one registration trial in
non-small cell lung cancer. Most treatment-related adverse
events (AEs) were grade 1 or 2, the most common of which were
transaminase elevations and diarrhea, which are generally
considered common for TKIs. Other common treatment-related
AEs included anemia, neutropenia and thrombocytopenia, each of
which are generally considered typical AEs with long-term use of
TKIs. No unexpected AEs were reported.
About ACEA Therapeutics
ACEA Therapeutics is
committed to developing and delivering innovative treatments to
improve the lives of patients with life-threatening diseases. ACEA
has expanded drug discovery efforts to encompass development in
both targeted cancer therapy and immunotherapy areas. Alongside a
robust R&D organization, ACEA has established drug
manufacturing in China to support
its long-term growth. This infrastructure provides ACEA greater
control over drug supply chain to make sure products are delivered
to patients on-time and at the highest quality. ACEA is well
positioned to deliver on its promise to bring innovative treatments
to patients living with life-threatening diseases while creating
value for shareholders, employees, and society.
For more information visit www.aceatherapeutics.com
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™.
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 is
completing 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 Abivertinib and its potential ability to lower
inflammatory cytokines associated with cytokine storm and poor
prognosis in COVID-19 patients, the anticipated effects and
clinical benefits of Abivertinib in patients with COVID-19 and the
anticipated Phase 2 trial of Abivertinib in patients with COVID-19
. 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 conducting clinical trials and seeking regulatory
approval of Abivertinib; that prior test results may not be
replicated in future studies and trials; conducting and receiving
results of clinical trials for Abivertinib; the viability and
success of using Abivertinib for the treatment of inflammatory
cytokines associated with cytokine storm and poor prognosis in
COVID-19 patients; risks related to Sorrento's and its
subsidiaries', affiliates' and partners' technologies and prospects
and collaborations with partners, including, but not limited to
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 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 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.
Contact
Alexis 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™,
Saving-Life™ and Improving-Life™ 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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SOURCE Sorrento Therapeutics Inc.