Sorrento Therapeutics Inc. (NASDAQ: SRNE) and Lee’s Pharmaceutical Holdings Limited have announced that on July 15, 2021, Lee’s Pharm’s subsidiary China Oncology Focus Limited(COF) enrolled the first subject in Phase 3 randomized, placebo-controlled, double-blinded multicentre clinical study of Socazolimab in combination with chemo in the first line extensive-stage small-cell lung cancer treatment. China’s National Medical Products Administration gave the clinical trial approval in March 2021.
COF enrolls the first subject in Socazolimab study
The decision to start the Phase 3 trial was based on the good efficacy and safety profile of Socazolimab coupled with etoposide and carboplatin in patients with advanced-stage small-cell lung cancer in a previous Phase Ib trial. Notably, Shun Lu of Shanghai Chest Hospital is leading this clinical investigation, including 56 study locations.
Sorrento discovered Socazolimab, an entirely human anti-PD-L1 monoclonal antibody, using their unique G-MAB library technology. China Oncology Focus has been granted exclusive rights to develop and market the antibody in Greater China, encompassing Mainland China, Macau, Taiwan, and Hong Kong. Socazolimab’s possible advantages over its competitors include being a fully human antibody which means it may have minimal immunogenicity, as evidenced by the development of negative antigen-derived antibodies (ADA) in humans in previous trials. Also, in comparison with other anti-D-L1 antibodies, Socazolimab requires a lower dose to attain efficacy, and its antibody-dependent cellular cytotoxicity and immune checkpoint inhibition have dual action mechanism.
Socazolimab has been tested in various cancers.
Socazolimab has been tested in metastatic or recurrent cervical cancer, high-grade osteosarcoma maintenance therapy after adjuvant chemotherapy, metastatic and locally advanced urothelial carcinoma, ES-SCLC in combination with etoposide and carboplatin, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel.
COF is developing other assets besides socazolimab, which is in clinical stage studies. The Lee Pharm subsidiary has developed a pipeline of ten assets vial in-licensing and internal development, putting it in a unique position to leverage immune-oncology as the foundation therapy in combination with other products.
