Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento")
announced today positive
preliminary results from two Phase 2 studies designed to
identify the hospitalized patient population suffering from
COVID-19-induced pneumonia and respiratory depression likely to
respond to treatment with oral Abivertinib. Abivertinib is a novel
small molecule tyrosine kinase inhibitor (TKI) that selectively
targets both mutant forms of the epidermal growth factor receptor
(EGFR) as well as Bruton's tyrosine kinase (BTK). 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 with potent
inhibition of key pro-inflammatory cytokine production, including
IL-1 beta, IL-6 and TNF-alpha. These cytokines are associated with
acute respiratory distress syndrome (ARDS), and with cytokine
release syndrome (CRS) or cytokine storm, and COVID-19 disease
progression with poor outcomes in patients.
The US study, entitled “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), recently
completed enrollment (N=96 randomized 1:1). The Brazil study,
entitled “A Phase 2, Randomized, Double-Blind, Placebo-controlled
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate)
in Subjects Hospitalized Due to COVID-19” also completed enrollment
(N=400, randomized 3:1 active vs. placebo). Both studies were
designed to assess the potential clinical benefits of Abivertinib’s
ability to reduce inflammatory cytokine storm associated with
COVID-19-induced respiratory depression. It was also important to
identify the potential patient population most likely to respond to
treatment based upon severity of COVID-19 respiratory depression at
baseline. In both studies the clinical status was assessed using a
9-point (0 to 8) categorical scale, where 3=hospitalized with no
oxygen therapy, 4=hospitalized with oxygen by mask or nasal
cannulae, 5=non-invasive ventilation or high flow oxygen,
6=intubation and mechanical ventilation, 7=additional organ support
such as extracorporeal membrane oxygenation, and 8=death.
Brazilian Protocol Design |
U.S. Protocol Design |
Mild, Moderate and Severe COVID-19 patients |
Severe COVID-19 patients |
Any hospitalized patient |
ICU non-ventilated |
N=400 randomized 3:1
(Abivertinib to placebo); stratified for COVID-19 severity at
baseline |
N=96 randomized 1:1 (Abivertinib to
placebo) |
100 mg QD
x 7 days |
100 mg QD x 14
days or discharge if sooner |
All patients received standard of care treatment for COVID-19 |
All patients received standard of care treatment for COVID-19 |
Duration 65 days |
Duration 94 days |
Primary endpoint: % alive and discharged
at one month |
Primary endpoint: % alive and free of
respiratory failure at one month |
NCT 04528667 ANVISA (Brazilian authority) under Process
nº 25351.105670/2020-14, Reference
n° 3380614/20-4 |
NCT 04440007 |
In the US Abivertinib study, most patients (57%)
were sicker at baseline (category 5 clinical status) with patients
in the Abivertinib group skewed to sicker or worse severity by
clinical status (Abivertinib Group: 29/48: 60% vs. Control Placebo
Group: 26/48: 38% for category 5, respectively) and by oxygenation
status (P/F ratio 211 vs. 253, respectively). In the Brazil
Abivertinib study, only 8% were in category 5, demonstrating a far
less severely compromised population having been enrolled. In the
US study, patients in category 5 showed a 20% improvement (78.3%
survival vs. 58.3%) in the primary endpoint of avoiding death and
respiratory failure at one month, and in the Brazil study, a 25%
improvement (69.6% vs. 44.4%), respectively for Abivertinib vs.
controls. In the US study, patients in category 5 treated with
Abivertinib were discharged from the hospital 2 days sooner than
those in the Control Group (8.6 vs. 10.6 days). Overall, in both
studies patients who were in category 5, but not in category <
4, showed improvement with Abivertinib treatment. Based upon these
preliminary results, a pivotal multi-country, multi-center pivotal
Phase 3 study is being planned in 400 patients (randomized 1:1) on
the At-Risk Hospitalized COVID-19 Patients requiring oxygen support
via non-invasive ventilation or high flow oxygen at baseline
(category 5 patients).
“Patients on non-invasive ventilation or high
flow oxygen supplementation due to COVID-19-induced respiratory
failure represent a sicker and at-risk population with few
available treatment options,” stated Dr. Mike Royal, Chief
Medical Officer of Sorrento Therapeutics. “Abivertinib has the
potential to fill this unmet need and significantly reduce
progression to intubation, mechanical ventilation and death.”
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, COVIGUARD™, COVI-AMG™,
COVISHIELD™, 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 Abivertinib, including the potential safety and clinical
benefits thereof; the safety and efficacy of Abivertinib in
patients with COVID-19 and in acute respiratory distress; the
potential for treatment with Abivertinib to reduce cytokine storm
associated with acute respiratory distress syndrome (ARDS) in
severe hospitalized COVID-19 patients; the identification of an
at-risk COVID-19 patient population based on likelihood of response
to treatment; the potential for Abivertinib to reduce progression
to intubation, mechanical ventilation and death in at-risk COVID-19
patients; the preliminary results of the two Phase 2 trials
conducted in the US and Brazil to date; the continued enrollment
and potential commencement of any future clinical trials for
Abivertinib; the potential for preliminary data results to be
replicated or continue to show improved clinical safety or
efficacy; 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
Abivertinib; 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; the possibility of
unfavorable new preclinical or clinical trial data and further
analyses of existing preclinical or clinical trial data; risks
associated with preliminary data; the risk that clinical trial data
are subject to differing interpretations and assessments, including
during the peer review/publication process, in the scientific
community generally, and by regulatory authorities; 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
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™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, 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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