Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 161 |
| INN | Socazolimab |
| Status | Approved |
| Drug code(s) | ZKAB001, STI-A1014 |
| Brand name | Shan Keyu |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-L1 |
| Indications of clinical studies | Biliary Tract Cancer, Urothelial Carcinoma, Esophageal Squamous Cell Carcinoma, Osteosarcoma, Small Cell Lung Cancer, Solid tumors, cervical cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Socazolimab |
| US or EU approved indications | None |
| Company | Sorrento Therapeutics |
| Licensee/Partner | Lee's Pharmaceutical Holdings |
| Comments about company or candidate | On December 21, 2023, the official website of the Food and Drug Administration showed that the new drug marketing application for the anti-PD-L1 monoclonal antibody socazolimab injection (Socazolimab) submitted by Zhaoke Oncology Drug Co., Ltd., a subsidiary of Lee's Pharmaceutical Co., Ltd., was approved in China. March 2023: “ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED 31 DECEMBER 2022”, which was issued on March 30, 2023 - China Oncology Focus Limited (“COF”), a 65% owned subsidiary of the Group, is a clinical development stage company and the Group’s R&D arm focused on oncology with emphasis in immuno-oncology. To date, COF has built a pipeline of 10 oncology assets, including 6 innovative and 4 generics, through internal development and in licensing, and is currently developing several assets, including (1) Socazolimab (an anti-PD-L1 antibody) in recurrent or metastatic cervical cancer in new drug application stage in China; (2) Socazolimab in osteosarcoma in Phase III clinical trial; (3) Socazolimab combined with chemotherapy in small cell lung cancer in Phase III clinical trial and has completed the patient enrollment in May 2022; (4) Zotiraciclib, an oral multi-kinase inhibitor in Phase I clinical trial for glioblastoma; (5) Gimatecan, a topoisomerase I inhibitor in Phase II clinical trial for ovarian cancer and in – 19 – Phase Ib/II clinical trial for small cell lung cancer and a Phase I clinical trial for pancreatic cancer in China; and (6) Socazolimab combined with Pexa-vec (oncolytic virus) which is in Phase Ib clinical trial for melanoma. [https://www.leespharm.com/wp-content/uploads/2023/03/2023033000811.pdf] May 17, 2022 - Sorrento Therapeutics, Inc. announced that its license partner, China Oncology Focus Limited (“COF”), a subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”), has completed the patient enrollment for a Phase III, 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. Nov 1, 2021: Sorrento Therapeutics, Inc. announced that its license partner, China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited 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. The NDA application has been accepted by China NMPA. NCT04878016 / CTR20210969 Phase 3 in small cell lung cancer started in July 2021; July 2021: China Oncology Focus, a subsidiary of Lee’s Pharm, has enrolled the first patient in the Socazolimab double-blinded Phase 3 study in combination with chemotherapy as a first-line treatment of extensive-stage small-cell lung cancer. March 07, 2021: China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited announced that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a Phase 3 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. 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). Feb 2021: China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma, HKEX: 950), and Sorrento Therapeutics, Inc., announced 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. NCT04359550 Phase 3 study in Osteosarcoma not yet recruiting when posted on April 24, 2020. NCT04346914 Phase 1 study in small cell lung cancer started in March 2020. As of April 2019, trial readouts expected in Q4 2019 for cervical cancer, urothelial carcinoma and sarcoma studies; ZKAB001 CTA filing (1H20, anticipated, conditional filing, no date announced). NCT03676959 Phase 1 in cervical cancer started in Sep 2018. Jan. 29, 2018: Lee’s Pharm and Sorrento Therapeutics announce that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics.Working on stable cell line development of human mAbs as of Oct 2013; STI-A1014 licensed to China Oncology Focus Limited, an Affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma) in Oct 2014 (https://www.sec.gov/Archives/edgar/data/850261/000119312514425173/d826599dex102.htm). Lee's Pharmaceutical Holdings Ltd, entered into agreement with Shenogen Pharma Group Ltd, to jointly develop and commercialize a combination product that is composed of their respective compounds, ZKAB001 (PD-L1 monoclonal antibody) and icaritin, for treatment of late stage cancers in China. The transaction enables Lee's Pharma and Shenogen Pharma to develop and commercialize ZKAB001 and icaritin. |
| Full address of company | 9380 Judicial Drive San Diego, CA 92121 North America United States of America https://sorrentotherapeutics.com/contact/ |
IgG1 lambda2. Immune checkpoint modulator. ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |