Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer

On March 7, 2021 China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharm, HKEX: 950) reported that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a multicenter, randomized, double blinded, parallel-group 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 (Press release, Sorrento Therapeutics, MAR 7, 2021, View Source [SID1234576176]). The clearance is based on the 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. The Principal Investigator for the clinical trial will be Professor Shun Lu from the Shanghai Chest Hospital and the site is expected to initiate patient recruitment in the second quarter of 2021.

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Socazolimab is an in-licensed product from Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") for the People’s Republic of China, Hong Kong, Macau and Taiwan. 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 purposes. For recurrent or metastatic cervical cancer, a pivotal study has been completed and breakthrough therapy designation was granted by the NMPA in February 2021. Lee’s Pharm expects to file the New Drug Application for Socazolimab in recurrent or metastatic cervical cancer in the second quarter of 2021. Apart from monotherapies, several studies of Socazolimab combining with chemotherapy are being conducted in advanced urothelial carcinoma (Phase Ib), extensive-stage small-cell lung cancer (Phase III), and neoadjuvant treatment in esophageal carcinoma (Phase Ib+II).

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, "We at Sorrento are pleased with the collaboration with our colleagues at Lee’s Pharm and with the further advances of our first therapeutic antibody partnership in Socazolimab."

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.