Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that its license partner, China Oncology Focus Limited
(“COF”), a subsidiary of Lee’s Pharmaceutical Holdings Limited
(“Lee’s Pharm”), has completed the patient enrollment for a Phase
III, 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”).
This clinical trial involves 54 centers and is
led by Prof. Shun Lu (陸舜) from Shanghai Chest Hospital (上海市胸科醫院).
The clinical trial approval was granted by China’s National Medical
Products Administration (“NMPA”) on 1 March 2021, and the first
patient was enrolled on 15 July 2021. A total of 498 patients have
been enrolled into the study. An interim analysis is expected to be
conducted in April 2023.
Socazolimab is an in-licensed product from
Sorrento for the People’s Republic of China, Hong Kong, Macau and
Taiwan. To date, 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
purpose.
For recurrent or metastatic cervical cancer, a
pivotal study has been completed and breakthrough therapy
designation has been granted by the NMPA in February 2021, and a
New Drug Application therefor was submitted to and accepted by the
Center for Drug Evaluation of the NMPA for review in October 2021.
Apart from monotherapies, several studies of Socazolimab combined
with chemotherapy are being conducted in advanced urothelial
carcinoma (Phase Ib), ES-SCLC (Phase III), neoadjuvant treatment in
esophageal carcinoma (Phase Ib+II), metastatic melanoma (Phase Ib)
and resected biliary tract cancer (Phase I).
About Socazolimab
Socazolimab is a fully human anti-PD-L1
monoclonal antibody identified by Sorrento using its proprietary
G-MAB™ library platform. 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.
About ES-SCLC and Immunotherapy
Atezolizumab, a PD-L1 inhibitor, in combination
with carboplatin and etoposide, was approved by the NMPA as a
first-line treatment for extensive-stage small cell lung
cancer.
The treatment was a major milestone and the
first new treatment for the aggressive cancer in decades; it
increased the median overall survival by 2 months and reduced the
risk of death by 23% compared with chemotherapy alone in this
disease setting. The advance was celebrated as a major milestone.
Durvalumab, another PD-L1 inhibitor, has been granted the New Drug
Approval (NDA) in ES-SCLC in China early this month. No PD-1
inhibitor has been approved in this indication.
About China Oncology Focus Limited (COF)
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 for
ovarian cancer; 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 Pharm
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 over 25 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 and obstetrics, 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.
More information available at www.leespharm.com.
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, COVISHIELD™ and COVI-MSC™;
and diagnostic test solutions, including COVIMARK™.
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 postherpetic neuralgia (PHN). RTX has
been cleared for a Phase II trial for intractable pain associated
with cancer and a Phase II trial in osteoarthritis patients.
Positive final results from the Phase III Pivotal Trial C.L.E.A.R.
Program for SEMDEXA™, its novel, non-opioid product for the
treatment of lumbosacral radicular pain (sciatica), were announced
in March 2022. 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; the therapeutic and clinical potential of
Socazolimab; the potential safety and efficacy of Socazolimab,
including Abivertinib’s potential efficacy against ES-SCLC; the
expected timing of the interim analysis of the Phase III study; and
the potential advantages of Socazolimab over its competitors. 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 safety and efficacy 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 continuing or 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 product
candidates’ 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, 2021 and subsequent Quarterly Report 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: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are
trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ (SP-102) is a trademark of Semnur
Pharmaceuticals, Inc. A proprietary name review by the FDA is
planned.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
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