Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that its license partner, China Oncology Focus Limited
(COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's
Pharma, HKEX: 950) has submitted a NDA (new drug application) for
the anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF
for the greater China territory to treat recurrent or metastatic
cervical cancer. The NDA application has been accepted by China
NMPA.
In February 2021, Sorrento and Lee’s Pharma
announced that socazolimab had been granted breakthrough
designation by the NMPA. If approved by NMPA, this will be the
first approved fully human antibody discovered and isolated from
Sorrento’s proprietary G-MAB™ library. “This is a major step
forward that demonstrates the power of discovery and development
engines at Sorrento for producing proprietary biopharmaceuticals
for unmet medical needs,” said Dr. Henry Ji, Chairman and CEO of
Sorrento.
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, pediatrics, 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 and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™,
COVISHIELD™, 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 socazolimab; and the potential efficacy and safety
profile of a Socazolimab product candidate in patients with
recurrent or metastatic cervical 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
technologies and prospects, including, but not limited to risks
related to seeking regulatory approval for socazolimab; 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™, 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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