Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that the first patient has been treated in a Phase 1b
proof-of-concept, open-label study to assess the safety and pilot
efficacy of Enbrel administered by the Sofusa Lymphatic Delivery
System for the treatment of Rheumatoid Arthritis.
Abnormal immune system function is implicated in
many conditions such as cancer and autoimmune diseases (e.g.,
Rheumatoid Arthritis, Multiple Sclerosis and Psoriasis). Sofusa’s
nanotopography draped microneedles have been shown to reversibly
open tight junctions in the skin and facilitate paracellular and
transcellular transport across the epidermis directly into the
lymphatic system. In pre-clinical biodistribution studies, these
proprietary microneedles and microfluidics system have consistently
demonstrated the ability to deliver over 40-fold increases in drug
concentration to targeted lymph nodes (with lower drug
concentration in systemic organs) when compared to traditional
intravenous (“IV”) and subcutaneous (“SC”) injections. After a
1-hour administration with Sofusa, elevated lymph node
concentrations have been measured beyond 72 hours.
Clinical study STI-SOFUSA-1003 is focused on
patients with moderate to severe Rheumatoid Arthritis. Patients
eligible for this study are those who failed to develop an adequate
response to Enbrel delivered through SC injections. “While biologic
therapy helps many patients with autoimmune conditions, there are
many who do not achieve an adequate response. Enbrel is an approved
and well-characterized drug for Rheumatoid Arthritis, and by
switching non-responding patients to Sofusa-delivered Enbrel, we
hope to clearly evaluate the safety and efficacy benefits
associated with delivering biologic drugs directly into the
lymphatics,” noted Brian Cooley, Senior Vice President, Sofusa
Lymphatic Drug Delivery Systems.
Study participants with Rheumatoid Arthritis
must be on a stable dose and non-responding on Enbrel 50 mg once
weekly for at least 12 weeks before inclusion in the study.
Patients start on a Sofusa-delivered Enbrel dose of 25 mg (50% of
the normal dose) during the induction phase of the study and may be
increased to a Sofusa-delivered Enbrel dose of 50 mg after 4 weeks,
if necessary, during the dose escalation phase of the study.
Sofusa-delivered Enbrel is administered once weekly for 12
weeks.
The primary objective of this study is the
safety and tolerability of the Sofusa Lymphatic Delivery System
with Enbrel administered once weekly in patients with Rheumatoid
Arthritis. Pilot efficacy is also measured in this study using
various composite scores for disease activity, including the DAS28
score, where DAS stands for “disease activity score” and the 28
refers to the 28 joints that are examined in each assessment. “The
first patient meeting the inclusion criteria of the study enrolled
with a baseline assessment, including ESR value of 6, having a
total count of swollen joints of 7 and tender joints of 11, Patient
Global Assessment of Disease Activity of 52, and a DAS28 score of
4.58. After just 4 weekly doses of Enbrel 25mg with Sofusa
delivery, the patient’s DAS score improved to 3.1, with a total of
5 swollen joints and 6 tender joints, ESR value of 2, and a Patient
Global Assessment of Disease Activity of 44. In addition, no
serious adverse events have been observed. While this is just the
first patient in an open label study, this initial result is quite
encouraging and in the right direction. We are looking forward to
enrolling more patients into this study,” said Dr. Roel N.
Querubin, Principal Investigator, Atlanta Research Center for
Rheumatology.
As an exploratory endpoint, this study is also
evaluating lymphatic pumping rates via near infrared fluorescence
(NIRF) imaging. Improper lymphatic function and reduced lymphatic
pump rates have been implicated in several autoimmune conditions1.
“In Collagen Induced Arthritic pre-clinical models, we have seen an
improvement in lymphatic pumping when delivering Enbrel with Sofusa
vs subcutaneous injections. Our hypothesis is that poor lymphatic
function may be associated with non-response to systemic treatment.
By delivering biologic drugs directly into the lymphatic system, we
may improve lymphatic function and provide more direct and
sustained exposure to therapeutic targets known to modulate immune
responses,” noted Russell Ross, Chief Technical Officer of Sofusa
Lymphatic Delivery Systems.
1 Rahimi et. al., Arthritis Research and
Therapy, “Lymphatic imaging to assess rheumatoid flare: mechanistic
insights and biomarker potential” (2016) 18: 194.
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 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 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 the Phase 1b study to
provide data regarding lymphatic pumping rates as an exploratory
endpoint; the potential for delivery of biologic drugs directly
into the lymphatic system to improve lymphatic function and provide
direct and sustained exposure to therapeutic targets; 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; 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 Sorrento
in the execution of its 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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