China Oncology Focus Limited (COF), an affiliate of Lee's
Pharmaceutical Holdings Limited (Lee's Pharm, HKEX: 950) announced
that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento
to COF for the greater China territory, has been cleared to begin a
multicenter, randomized, double blinded, parallel-group 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. The clearance
is based on the 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. The Principal Investigator
for the clinical trial will be Professor Shun Lu from the Shanghai
Chest Hospital and the site is expected to initiate patient
recruitment in the second quarter of 2021.
Socazolimab is an in-licensed product from
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) for the
People’s Republic of China, Hong Kong, Macau and Taiwan. Three
Phase I clinical trials of Socazolimab monotherapy have been
completed: (1) recurrent or metastatic cervical cancer; (2)
advanced urothelial carcinoma; and (3) high-grade osteosarcoma
after adjuvant chemotherapy for maintenance purposes. For recurrent
or metastatic cervical cancer, a pivotal study has been completed
and breakthrough therapy designation was granted by the NMPA in
February 2021. Lee’s Pharm expects to file the New Drug Application
for Socazolimab in recurrent or metastatic cervical cancer in the
second quarter of 2021. Apart from monotherapies, several studies
of Socazolimab combining with chemotherapy are being conducted in
advanced urothelial carcinoma (Phase Ib), extensive-stage
small-cell lung cancer (Phase III), and neoadjuvant treatment in
esophageal carcinoma (Phase Ib+II).
Dr. Henry Ji, Chairman and CEO of Sorrento
Therapeutics, stated, “We at Sorrento are pleased with the
collaboration with our colleagues at Lee’s Pharm and with the
further advances of our first therapeutic antibody partnership in
Socazolimab.”
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; Lee’s Pharm’s plan to file a new
drug application for Socazolimab in China; and the expected timing
for filing a new drug application for Socazolimab in China. 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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