Sorrento Announces First Patient Treated in Phase IB AL Amyloidosis Trial with STI-6129, an Anti-CD38 Antibody-Drug Conjugate...
March 18 2021 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that the first patient has been treated in its Phase 1b
Amyloid Light Chain (AL) Amyloidosis study of STI-6129, an ADC
which uses STI-5171, a fully human monoclonal antibody (mAb) from
Sorrento’s G-MAB™ library. This study is being conducted as a
multicenter, open-label, dose-escalation clinical trial in patients
with advanced relapsed and/or refractory systemic amyloid light
chain (AL) amyloidosis with a primary objective to identify a Phase
2 dose for STI-6129 based on its safety, preliminary efficacy and
pharmacokinetic profile.
STI-6129 is an ADC with covalently bound
duostatin tubulin inhibitors (Duostatin 5) using a proprietary
site-specific C-LOCK™ chemical linker designed to reduce the
premature systemic release of duostatin and avoid the potential for
toxicity, particular ocular toxicity, seen with other ADCs,
especially first-generation products. STI-6129 has demonstrated an
improved therapeutic index in animal models, as compared to
traditional non-selective conjugates. STI-6129 has the potential
for being a first-line treatment for amyloidosis as well as second
line in those patients who have developed daratumumab resistance,
an anti-CD38 mAb alone. STI-6129 binds to different epitopes than
daratumumab and the addition of the targeted delivery of the
duostatin can potentially manage those patients who have become
refractory to such treatments.
“Enrollment into our amyloidosis study with
STI-6129 is another important milestone for Sorrento, and although
delayed due to COVID-19, we are pleased this study has started,”
stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.
“Together with our CD38 CAR-T and DAR-T programs, STI-6129 has the
potential to provide additional therapeutic options for patients in
need and we are excited to see how it performs in treating patients
with AL amyloidosis. We also are looking forward to further
evaluating the safety and efficacy of STI-6129 in a soon to start
refractory or relapsing multiple myeloma clinical trial.”
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 (“ADCs”), 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 potential safety and efficacy profile of STI-6129;
the use of a C-LOCK chemical linker to reduce premature systemic
release of duostatin, and avoid or reduce the toxicity, of
STI-6129; the improved therapeutic index of STI-6129 in animal
models as compared to traditional ADCs; the potential for STI-6129
to be a first-line treatment for amyloidosis and a second-line
treatment in patients who have developed resistance to daratumumab;
the potential for STI-6129 to treat treatment-refractory patients;
and the plan and expected timing for commencing refractory or
relapsing multiple myeloma clinical trials. 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 STI-6129; 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 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
Sorrento Therapeutics 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™, 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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