China Oncology Focus, a subsidiary of Lee’s Pharm, has enrolled the first patient in the phase 3 double-blind study of Socazolimab in combination with chemotherapy as a first-line treatment for advanced small cell lung cancer.
Socazolimab is an anti-PD-L1 antibody licensed from Sorrento for the Greater China Territory by Lee’s Pharm.
SAN DIEGO, July 23, 2021 (GLOBE NEWSWIRE) – Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and Lee’s Pharmaceutical Holdings Limited (HKEX: 950, “Lee’s Pharm”) today announced that on the 15th July, 2021, China Oncology Focus Limited (“COF”), A subsidiary of Lee’s Pharm, enrolled the first patient in China in the Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as the name ZKAB001) in combination with chemotherapy for the first-line treatment of large-stage small cell lung cancer (ES-SCLC). Authorization for clinical trial has been granted by the National Administration of Medicinal Products of China (“NMPA”) In March 2021.
The launch of this phase 3 trial is based on the very encouraging results of an earlier phase Ib trial in which socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with the disease. advanced small cell lung cancer. This clinical trial involves 56 centers and is led by Professor Shun Lu of Shanghai Chest Hospital.
Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB ™ library platform. COF received the exclusive rights to develop and commercialize the antibody for Greater China, which includes mainland China, Hong Kong, Macao and Taiwan. Socazolimab has the following potential advantages over its competitors:
An all-human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative generation of antigen-derived antibodies (ADA) in humans in studies to date.
Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
Double 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 treatment of high-grade osteosarcoma after adjuvant chemotherapy, urothelial carcinoma locally advanced and metastatic, 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-focused biopharmaceutical company developing new therapies to treat cancer and COVID-19. Sorrento’s multimodal and multidimensional approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB ™ library”), immune therapies – clinical stage cells (“CAR-T”, “DAR-T ™”), antibody-drug conjugates (“ADC”) and clinical stage oncolytic virus (“Seprehvir ™”). Sorrento is also developing antiviral therapies and potential coronavirus vaccines, 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 is also demonstrated by our efforts to advance a first-class non-opioid pain management small molecule (TRPV1 agonist), resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA ™), a new viscous gel formulation of a corticosteroid widely used for epidural injections to treat lumbosacral radicular pain, or sciatica, and to market ZTlido® (topical lidocaine system) postherpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in patients with osteoarthritis. 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 an oncology-focused clinical development company. COF is currently developing several active ingredients, including socazolimab (anti-PD-L1 antibody) in a pivotal clinical trial phase; Zotiraciclib, an oral multi-kinase inhibitor in a 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 a worldwide Phase Ib clinical trial for renal cell cancer. COF has built a pipeline of 10 assets through internal development and licensing. The diversity of its products creates a unique position for the company to use immune oncology as a core therapy in combination with internal products and to develop a potential paradigm shift treatment for cancer.
About Lee’s Pharmaceutical Holdings Limited
Lee’s Pharm is a research and market driven biopharmaceutical company with more than 25 years in the pharmaceutical industry in China. The Company is fully integrated with strong infrastructure in drug development, clinical development, regulation, manufacturing, sales and marketing based in Mainland China with global outlook. The Company has established extensive partnerships with more than 20 international companies and currently markets 23 proprietary, generic and authorized pharmaceutical products in Mainland China, Hong Kong, Macao and Taiwan. The Company focuses on several key disease areas such as cardiovascular disease, women’s health, pediatrics, rare diseases, oncology, dermatology, obstetrics and urology, and has more than 40 products at various stages of development resulting from both internal research and development as well as the licensing and rights of development, marketing and manufacturing of various American, European and Japanese companies. Lee’s Pharm has also been involved in the ophthalmology sector through its investment in Zhaoke Ophthalmology Limited, an associate of the Group.
For more information visit www.leespharm.com.
This press release and all statements made for and during any presentation or meeting contain forward-looking statements relating 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. which 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 advanced 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, without limitation: risks relating to the technologies and prospects of Sorrento and its subsidiaries, affiliates and partners and collaborations with partners, including, but not limited to, risks associated with seeking regulatory approval for any Socazolimab product candidate; clinical development risks, including risks related to the progress, timing, costs and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; the risks that the results of a clinical study will not meet all or part of the parameters of a clinical study and that the data generated from these studies may not support a regulatory submission or approval; the risks that the results of previous tests, studies and trials will not be reproduced in future studies and trials; risks associated with the manufacture and supply of pharmaceutical products; risks associated with using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in executing its therapeutic drug candidate strategies; risks associated with the global impact of COVID-19; and other risks which 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 fiscal 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 out in those documents. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we assume no obligation to update any forward-looking statements contained in this press release, unless the law requires it.
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