On November 1, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that its license partner, China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma, HKEX: 950) has submitted a NDA (new drug application) for the anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory to treat recurrent or metastatic cervical cancer (Press release, Sorrento Therapeutics, NOV 1, 2021, View Source [SID1234594001]). The NDA application has been accepted by China NMPA.
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In February 2021, Sorrento and Lee’s Pharma announced that socazolimab had been granted breakthrough designation by the NMPA. If approved by NMPA, this will be the first approved fully human antibody discovered and isolated from Sorrento’s proprietary G-MAB library. "This is a major step forward that demonstrates the power of discovery and development engines at Sorrento for producing proprietary biopharmaceuticals for unmet medical needs," said Dr. Henry Ji, Chairman and CEO of Sorrento.
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, advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.