Sorrento Announces That Its Subsidiary Levena and Its Partner Escugen Have Received Clearance to Begin Clinical Trials With Anti-TROP-2 Antibody Drug Conjugate For Multiple Solid Tumors
July 21 2021 - 2:09PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced
today its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and
Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd.
(“Levena”) have received an approval letter from the Center for
Drug Evaluation (CDE) of the National Medical Products
Administration (NMPA) for its Application for Clinical Trial
(Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2
Mab-SN38 Conjugate.
The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based
Escugen and Levena, and the two companies jointly own the domestic
and international patents for this ADC and share global rights for
the product.
ESG-401 has potentially distinct differentiating advantages over
its competitors in terms of safety, effectiveness and process
robustness. Using an innovative, highly stable and cleavable
linker, this ADC demonstrated in a series of preclinical studies
that it releases very little free toxin during circulation, highly
enriches in tumor tissues and rapidly endocytoses, thereby
effectively killing tumor cells and inhibiting tumor growth. In the
preclinical studies, ESG-401 demonstrated excellent safety, with no
off-target or off-tumor toxicity observed in those high-dose,
repetitively administered non-human primates. Additionally, ESG-401
showed significant antitumor activity in a variety of tumor models
expressing TROP-2, with a low effective dosage and long inhibition
time on tumor growth. ESG-401 potentially addresses a highly unmet
need for the treatment of multiple solid tumors, including
triple-negative breast cancer and urothelial carcinoma.
Sorrento intends to file a US IND for this ESG-401 before the
end of the year.
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 therapeutic benefits of ESG-401; the
potential differentiating advantages of ESG-401 over its
competitors; the potential safety and efficacy of ESG-401; the
potential for ESG-401 to multiple solid tumors, including
triple-negative breast cancer and urothelial carcinoma; and
Sorrento’s expected timing for filing a US IND. 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
and receiving results of clinical trials for ESG-401; the viability
and success of using ESG-401 for treatments in therapeutic areas,
including triple-negative breast cancer and urothelial carcinoma;
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
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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