Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and Lee’s
Pharmaceutical Holdings Limited (HKEX: 950, “Lee’s Pharm”)
announced today that, on July 15, 2021, China Oncology Focus
Limited (“
COF”), a subsidiary of Lee’s Pharm, has
enrolled the first patient in China in the Phase 3, multicenter,
randomized, double blinded, placebo controlled clinical trial of
Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as
ZKAB001) combined with chemotherapy in the first-line treatment of
extensive-stage small-cell lung cancer (
ES-SCLC).
The clinical trial clearance was granted by China’s National
Medical Products Administration (“
NMPA”) in March
2021.
The initiation of this Phase 3 trial is based on
the very encouraging results from an earlier Phase Ib trial in
which Socazolimab combined with carboplatin and etoposide showed a
promising efficacy and safety profile in patients with
extensive-stage small-cell lung cancer. This clinical trial
involves 56 centers and is led by Prof. Shun Lu from Shanghai Chest
Hospital.
About Socazolimab
Socazolimab is a fully human anti-PD-L1
monoclonal antibody identified by Sorrento using its proprietary
G-MAB™ library platform. COF received exclusive rights to develop
and commercialize the antibody for Greater China, which includes
Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the
following potential advantages over its competitors:
- Fully human antibody potentially
allows it to have minimal immunogenicity; demonstrated by its
negative antigen-derived antibody (ADA) generation in humans in
studies to date.
- Potentially lower dose required to
achieve efficacy compared to other anti-PD-L1 antibodies.
- Dual mechanism of action observed
with both immune-checkpoint inhibition and antibody-dependent
cellular cytotoxicity (ADCC) effect.
The antibody has been tested or is being tested
in various cancer indications including recurrent or metastatic
cervical cancer, maintenance therapy for high-grade osteosarcoma
after adjuvant chemotherapy, locally advanced and metastatic
urothelial carcinoma, extensive small cell lung cancer in
combination with carboplatin and etoposide, and advanced urothelial
carcinoma in combination with albumin-bound paclitaxel and
esophageal carcinoma.
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.
About China Oncology Focus
Limited
COF is a subsidiary of Lee’s Pharm and a
clinical development stage company focused on oncology. COF is
currently developing several assets, including socazolimab
(anti-PD-L1 antibody) in pivotal clinical trial stage;
Zotiraciclib, an oral multi-kinase inhibitor in Phase I clinical
trial for glioblastoma; Gimatecan, a topoisomerase I inhibitor in
Phase I clinical trial for ovarian cancer and in Phase Ib/II
clinical trial for small cell lung cancer in China; Pexa-vec
(oncolytic virus) which is in global Phase Ib clinical trial for
renal cell cancer. COF has built a pipeline of 10 assets through
internal development and in-licensing. The diversity of its
products creates a unique position for the company to use immune
oncology as backbone therapy in combination with in-house products
and develop potential paradigm-shifting treatment for cancer.
About Lee's Pharmaceutical Holdings
Limited
Lee’s Pharm is a research-driven and
market-oriented biopharmaceutical company with more than 25 years
of operation in the pharmaceutical industry in China. The Company
is fully integrated with solid infrastructures in drug development,
clinical development, regulatory, manufacturing, sales and
marketing based in Mainland China with global perspectives. The
Company has established extensive partnerships with over 20
international companies and currently markets 23 proprietary,
generic and licensed-in pharmaceutical products in Mainland China,
Hong Kong, Macau and Taiwan. The Company focuses on several key
disease areas such as cardiovascular, woman health, paediatrics,
rare diseases, oncology, dermatology, obstetrics and urology, and
has more than 40 products under different development stages
stemming from both internal research and development as well as
from the licensing and development, commercialisation, and
manufacturing rights from various United States, European and
Japanese companies. Lee’s Pharm has also involved in the business
in ophthalmology through its investment in Zhaoke Ophthalmology
Limited, an associated company of the Group.
For more information visit
www.leespharm.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 efficacy and safety profile of a
Socazolimab product candidate in patients with extensive-stage
small-cell lung cancer. 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 seeking regulatory approval for any Socazolimab product
candidate; 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
Lee’s PharmaceuticalVivian
FungTelephone: +852 2314 1282Email: info@leespharm.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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