On February 9, 2021 China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma, HKEX: 950), and Sorrento Therapeutics, Inc. (Sorrento, Nasdaq: SRNE), reported that its anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory, has been granted breakthrough therapy designation (BTD) by the China National Medical Products Administration (NMPA) to treat recurrent or metastatic cervical cancer (Press release, Sorrento Therapeutics, FEB 9, 2021, View Source [SID1234574787]).
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The NMPA established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits as compared to existing therapies. Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).
"China NMPA granted socazolimab breakthrough therapy designation in recognition of both significant unmet medical need and positive and promising clinical results of socazolimab treatment for patients with recurrent or metastatic cervical cancer," said Dr. Benjamin Li Xiaoyi, Chief Executive Officer of Lee’s Pharma. "Cervical cancer is the fourth most lethal cancer in women worldwide and the third cause of cancer-related death in developing countries. There is currently no recommended standard of care treatment for this disease in China. Socazolimab has the potential to be the leading anti-PD-L1 antibody in the treatment of this indication. Socazolimab has demonstrated outstanding efficacy and safety profile in the clinical trials so far in treating cervical cancer patients."
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, "We at Sorrento are happy with the collaboration with our colleagues at Lee’s Pharma and are satisfied with the clinical advance of our first therapeutic antibody partnership in socazolimab. We currently plan to expand our partnership with Lee’s Pharma and are in discussions regarding the co-development of additional therapeutic antibodies from Sorrento to treat hematologic and solid tumors."
Lee’s Pharma plans to file a new drug application to China NMPA and request a fast-track conditional approval of socazolimab for the treatment of cervical cancer in Q2 2021.
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.