China Oncology Focus Limited (COF), an affiliate of Lee's
Pharmaceutical Holdings Limited (Lee's Pharma, HKEX: 950), and
Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE), today
announced that its anti-PD-L1 antibody, socazolimab, licensed from
Sorrento to COF for the greater China territory, has been granted
breakthrough therapy designation (BTD) by the China National
Medical Products Administration (NMPA) to treat recurrent or
metastatic cervical cancer.
The NMPA established its BTD program in July
2020 to facilitate the research and development of innovative drugs
that treat severe life-threatening or quality-of-life impairing
diseases with no existing therapy or with proven evidence to
demonstrate clear clinical benefits as compared to existing
therapies. Products with BTD from the NMPA may be considered for
conditional approval and priority review when submitting a New Drug
Application (NDA).
“China NMPA granted socazolimab breakthrough
therapy designation in recognition of both significant unmet
medical need and positive and promising clinical results of
socazolimab treatment for patients with recurrent or metastatic
cervical cancer,” said Dr. Benjamin Li Xiaoyi, Chief Executive
Officer of Lee’s Pharma. “Cervical cancer is the fourth most lethal
cancer in women worldwide and the third cause of cancer-related
death in developing countries. There is currently no recommended
standard of care treatment for this disease in China. Socazolimab
has the potential to be the leading anti-PD-L1 antibody in the
treatment of this indication. Socazolimab has demonstrated
outstanding efficacy and safety profile in the clinical trials so
far in treating cervical cancer patients.”
Dr. Henry Ji, Chairman and CEO of Sorrento
Therapeutics, stated, “We at Sorrento are happy with the
collaboration with our colleagues at Lee’s Pharma and are satisfied
with the clinical advance of our first therapeutic antibody
partnership in socazolimab. We currently plan to expand our
partnership with Lee’s Pharma and are in discussions regarding the
co-development of additional therapeutic antibodies from Sorrento
to treat hematologic and solid tumors.”
Lee’s Pharma plans to file a new drug
application to China NMPA and request a fast-track conditional
approval of socazolimab for the treatment of cervical cancer in Q2
2021.
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, advanced urothelial
carcinoma in combination with albumin-bound paclitaxel and
esophageal carcinoma.
About Lee's Pharmaceutical Holdings
Limited
Lee’s Pharma is a research-driven and
market-oriented biopharmaceutical company with more than 25 years
of operation in the pharmaceutical industry in Greater China. The
Company is fully integrated with solid infrastructures in drug
development, clinical development, regulatory, manufacturing, sales
and marketing based in Greater China with global perspectives. The
Company has established extensive partnerships with over 20
international companies and currently markets 23 proprietary 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,
development, commercialization and manufacturing rights from
various United States, European and Japanese companies. Lee’s
Pharma is also involved in the area of ophthalmology through its
investment in Zhaoke Ophthalmology Limited, an associated company
of the Group.
For more information
visit www.leespharm.com.
About China Oncology Focus
Limited
China Oncology Focus Limited (COF) is a
subsidiary of Lee’s Pharma and a clinical development stage company
focused in oncology with emphasis in immune 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 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 COVI-GUARD™, COVI-AMG™, COVI-SHIELD™,
GeneMAb™, COVI-MSC™ and COVI-DROPS™; and diagnostic test solutions,
including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.
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 Lee’s Pharma’s plan to file a new drug application for
socazolimab in China and to request fast-track conditional
approval; the expected timing for a new drug application for
socazolimab in China; the continued success of any current or
future clinical trials for a socazolimab product candidate;
discussions regarding potential expanded partnership opportunities
between Sorrento and Lee’s Pharma; potential license agreements
between Sorrento and Lee’s Pharma for additional therapeutic
antibodies from Sorrento’s G-MAB library, including licenses for
therapeutic antibodies to treat hematologic and solid tumors;
socazolimab’s potential status as the leading anti-PD-L1 antibody
in the treatment of recurrent or metastatic cervical cancer; the
safety and potential efficacy of a socazolimab product candidate;
and the potential for socazolimab’s data results to be replicated
or continue to show clinical safety or efficacy in current or
future 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 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, 2019, 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.
Lee’s PharmaceuticalMedia and
Investor RelationsContact: Vivian FungTelephone: +852 2314
1282Email: info@leespharm.com
Sorrento TherapeuticsMedia and
Investor RelationsContact: Alexis Nahama, DVM (SVP Corporate
Development)Telephone: 1.858.203.4120Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are
registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, COVI-GUARD™, COVI-AMG™,
COVI-SHIELD™, GeneMAb™, COVI-DROPS™, COVI-MSC™, COVI-TRACK™,
COVI-TRACE™ and COVI-STIX™ are trademarks of Sorrento
Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a 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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