Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
released a patient case report on the lymphatic delivery of Enbrel
using the Sofusa Lymphatic Delivery System (SOFUSA), which has been
submitted for preprint as CASE REPORT: Lymphatic delivery of
Enbrel® using The Sofusa® Lymphatic Delivery System (SOFUSA)
achieves improvement in rheumatoid arthritis disease activity
measures in a patient non-responsive to Enbrel subcutaneous
injections (https://www.medrxiv.org/).
The development of tumor necrosis factor (TNF) inhibitors has
greatly improved the treatment of RA, but many patients either do
not respond or relapse after therapy. TNF is produced by a variety
of immune cells that reside within lymph nodes and the lymphatic
system. A Phase 1b open label study is examining the changes in RA
disease progression by administering Enbrel, a TNF inhibitor, to
the lymphatic system and draining lymph nodes using the SOFUSA
device. The first patient to participate in this ongoing study was
a 43-year-old female who had an inadequate response to Enbrel after
11 months of once weekly 50mg Enbrel SC injections.
After 12 weeks of receiving SOFUSA with Enbrel at 25 mg weekly,
disease activity as measured by DAS28-ESR decreased 34.1% from 4.58
at Baseline to 3.02 at Week 12 demonstrating a change from moderate
to low disease activity. Similarly, DAS28-CRP decreased 37.5% from
4.99 at Baseline to 3.12 at Week 12 demonstrating a change from
high disease activity to moderate disease activity. The lowest
DAS28-ESR achieved was 2.10 at Week 10 after 10 weekly doses which
corresponds to a disease activity level of remission. A study
extension has been IRB approved to evaluate the potential for
further dose reductions in patients who respond well to 25 mg
weekly dosing.
Joint counts were performed every 2 weeks and a consistent
decrease in the number of tender and swollen joints was recorded
for the entire 12-week dosing period. The number of tender joints
decreased from Week 0 to Week 12 by 70.6% (full 68-Joint Count) and
90.9% (28-Joint Count). Similarly, the number of swollen joints
decreased from Week 0 to Week 12 by 44.4% (full 66-Joint Count) and
28.6% (28-Joint Count).
“Our hypothesis for this study was that delivering Enbrel
directly into the lymphatics would improve clinical response. While
this is only the first patient, the improvement is quite remarkable
and suggests that delivering therapy directly into the lymphatics
may be one of the factors associated with improved response to
biologic therapies delivered systemically. It was also quite
interesting to see the correlation between lymphatic flow and
clinical response. We are looking forward to enrolling more
patients in this study” – Roel Querubin, MD, Principal
Investigator, Atlanta Research Center for Rheumatology.
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 (“ADC”), 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 1b 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 Sofusa Lymphatic
Delivery System, including for the treatment of Rheumatoid
Arthritis; the ability of the Sofusa Lymphatic Delivery System to
reduce required dosing of a drug; the potential for the Sofusa
Lymphatic Delivery System to improve safety and efficacy and to
reduce required dosing as compared to traditional systemic or
subcutaneous injections or infusions; the clinical testing of a
SOFUSA product candidate; the preliminary results of the first
patient in the Phase 1b study to date; the continued enrollment and
potential commencement of future clinical trials for a SOFUSA
product candidate; the potential for pre-clinical study results to
be replicated or continue to show improved clinical safety or
efficacy in the current clinical trial and future clinical trials;
the potential for preliminary data results to be replicated or
continue to show improved clinical safety or efficacy as the
ongoing trial continues; the potential for delivery of biologic
therapies directly into the lymphatic system to improve response to
such biologic therapies; and Sorento’s potential position in the
therapeutics 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 clinical studies and seeking regulatory
approval for the Sofusa Lymphatic Drug Delivery Device, including
the timing for receipt of any such approval; conducting and
receiving results of clinical trials; 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 the
company in the execution of its COVID-19 therapeutic 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, 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.
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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