On July 23, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and Lee’s Pharmaceutical Holdings Limited (HKEX: 950, "Lee’s Pharm") reported that, on July 15, 2021, China Oncology Focus Limited ("COF"), a subsidiary of Lee’s Pharm, has enrolled the first patient in China in the Phase 3, 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, JUL 23, 2021, View Source [SID1234585139]). The clinical trial clearance was granted by China’s National Medical Products Administration ("NMPA") in March 2021.
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The initiation of this Phase 3 trial is based on the very encouraging results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer. This clinical trial involves 56 centers and is led by Prof. Shun Lu from Shanghai Chest Hospital.
About Socazolimab
Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. 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.
The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.