Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"),
announced today that the FDA has given clearance for Sorrento to
commence the Phase 3 clinical trial of Abivertinib in severe
COVID-19 patients (hospitalized patients with respiratory
compromise requiring oxygen supplementation). The clinical trial
will be conducted in 2 phases, and the initial run-in will define
the RP3D. In October 2021, Sorrento released preliminary results of
two phase 2 studies that seemed to show that patients hospitalized
with severe pneumonia due to COVID-19, especially those requiring
non-invasive ventilation or high flow oxygen supplementation, were
up to 5-fold more likely to benefit from Abivertinib therapy than
those patients who required low flow supplementation. Such patients
represent a high-risk population with few treatment options.
The study will be conducted at multiple sites in
the USA, Mexico and Brazil. “We are encouraged by the results from
our Phase 2 study, and excited to move Abivertinib to the next
stage to help these patients who have no good alternatives,” said
Dr. Henry Ji, Chairman and CEO of Sorrento.
Sorrento believes the availability of an oral
dosage form to manage inflammatory disease progression is very
relevant for severely afflicted patients with COVID-19-induced
respiratory failure and potentially non-COVID acute respiratory
distress syndrome (ARDS). This treatment has the potential to
provide significant benefits across the globe with respect to
logistical access, scalability and affordability by potentially
providing a treatment in a convenient oral dosage form. Sorrento
intends to explore the administration of Abivertinib for severe
non-COVID related pneumonia and ARDS patients, as the mechanism of
disease progression is very similar and the current medical options
for treatment are limited.
About Abivertinib
Abivertinib is a novel dual target, small
molecule tyrosine kinase inhibitor (TKI) designed to selectively
target mutant forms of the epidermal growth factor receptor (EGFR)
and Bruton's tyrosine kinase (BTK).
Abivertinib is a third generation EGFR inhibitor
that irreversibly targets mutant forms of EGFR in advanced
non-small cell lung cancer (NSCLC) patients resistant to first-line
EGFR kinase inhibitor therapies with comparable efficacy and
safety. Abivertinib demonstrated different resistant mechanisms
with rare occurrence of acquired resistant mutation, C797S and
potential inhibition of Osimertinib (Tagrisso) resistant tumors in
PDX models.
Abivertinib also irreversibly binds to the BTK
receptor, inhibiting the phosphorylation of the receptor required
for malignant cell survival such as B lymphocytes and prostate
cancer.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™,
COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including
COVITRACK™ and COVIMARK™.
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 (PHN). RTX has
been cleared for a Phase II trial for intractable pain associated
with cancer and a Phase II trial in osteoarthritis patients.
SEMDEXA announced highly statistically significant positive
top-line results from its Phase III Pivotal Trial C.L.E.A.R Program
for its novel, non-opioid product for the treatment of lumbosacral
radicular pain (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 Abivertinib and the planned Phase 2/3 clinical trial in
severe COVID-19 patients, including the expected phases of the
trial and sites for the trial; the preliminary results of the two
phase 2 studies that were announced in October 2021; Sorrento’s
belief that an oral dosage form is very relevant for severely
afflicted COVID-19 patients; the potential for Abivertinib to
provide significant benefits across the globe with respect to
logistical access, scalability and affordability; Sorrento’s
intention to explore the administration of Abivertinib for severe
non-COVID related pneumonia and ARDS patients and Sorrento’s
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 additional studies and seeking
regulatory approval for Abivertinib, including the timing for
receipt of any such approval; conducting and receiving results of
clinical studies; clinical development risks, including risks in
the progress, timing, cost, and results of clinical studies 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
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, 2021, 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: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ and COVIMARK™ 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.
©2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
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