On May 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported 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") (Press release, Sorrento Therapeutics, MAY 17, 2022, View Source [SID1234614738]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.