Socazolimab, an anti-PD-L1 monoclonal antibody discovered by Sorrento Therapeutics from its G-MAB™ library, is being tested in a Phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC). The trial, which has completed enrollment of 498 patients, is led by Prof. Shun Lu from Shanghai Chest Hospital and involves 54 centers across China. The clinical trial received approval from China’s National Medical Products Administration (NMPA) on 1 March 2021, with the first patient enrolled on 15 July 2021. An interim analysis is expected to be conducted in April 2023.
Socazolimab has been the subject of three completed Phase I clinical trials for various cancers, including recurrent or metastatic cervical cancer, advanced urothelial carcinoma, and high-grade osteosarcoma. For recurrent or metastatic cervical cancer, Socazolimab has been granted breakthrough therapy designation by the NMPA, and a New Drug Application was submitted and accepted for review in October 2021. In addition to monotherapy trials, Socazolimab is also being studied in combination with chemotherapy for several other cancers.
ES-SCLC is an aggressive form of lung cancer, and the approval of Atezolizumab, a PD-L1 inhibitor, in combination with chemotherapy, marked a significant advancement in its treatment. The combination therapy increased median overall survival by 2 months and reduced the risk of death by 23% compared to chemotherapy alone. Durvalumab, another PD-L1 inhibitor, has also received New Drug Approval for ES-SCLC in China. However, no PD-1 inhibitor has been approved for this indication.
China Oncology Focus Limited (COF), a subsidiary of Lee's Pharm, is developing Socazolimab among other oncology assets. COF's pipeline includes a variety of products aimed at treating different types of cancer, leveraging immune oncology as a backbone therapy in combination with in-house products to develop potential paradigm-shifting treatments for cancer.
Lee's Pharm, with over 25 years of operation in the pharmaceutical industry in China, focuses on several key disease areas and has established extensive partnerships with international companies. Sorrento Therapeutics, the licensor of Socazolimab, is a clinical and commercial stage biopharmaceutical company developing new therapies for cancer, pain, autoimmune disease, and COVID-19.
