Sorrento’s License Partner, Lee’s Pharm, Announces Full Enrollment of 498 Patients in a Phase III Trial of Socazolimab (Anti-PD-L1 AntibodyPD-L1 Antibody) for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)ES-SCLC)

18 May 2022
www.globenewswire.com
AntibodyClinical ResultCollaborateBreakthrough TherapyFirst in ClassVaccine
SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) -- 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) fromShanghai 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).
Socazolimab is a fully human anti-PD-L1 monoclonal antibodyPD-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 antibodiesPD-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 inhibitorPD-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 inhibitorPD-L1 inhibitor, has been granted the New Drug Approval (NDA) in ES-SCLC in China early this month. No PD-1 inhibitorPD-1 inhibitor has been approved in this indication.
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 antibodyPD-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.
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.
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 agonistTRPV1 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.
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