Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 4 |
| INN | Zimberelimab |
| Status | Approved |
| Drug code(s) | AB122, GLS-010 |
| Brand name | YuTuo® |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic rat (OmniRat) |
| Target(s) | PD-1 |
| Indications of clinical studies | Melanoma, Colorectal cancer, Metastatic Castrate Resistant Prostate Cancer, GI malignancies, Cervical cancer, non-small cell lung cancer, Hodgkin lymphoma, advanced malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2017 |
| Start of Phase 2 | August 24, 2018 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Zimberelimab |
| US or EU approved indications | None |
| Company | Harbin Gloria Pharmaceuticals |
| Licensee/Partner | WuXi Biologics, Arcus Biosciences, Taiho Pharma |
| Comments about company or candidate | Sep 2023: Approved in China for treatment of recurrent or metastatic cervical cancer NCT05518318 Phase 3 in Hodgkin lymphoma due to start in Sep 2022. In March 2022, Gloria Pharma filed the second NDA for GLS-010 (zimberelimab) – the sixth homegrown PD-1 antibody in China – for the treatment of cervical cancer. The drug received breakthrough therapy designation from the NMPA in March 2021. Aug 30, 2021: Ligand Pharmaceuticals Incorporated announced that its partner Gloria Biosciences (GloriaBio) has received approval from China’s National Medical Products Administration (NMPA) for zimberelimab (GLS-010), an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin’s lymphoma According to Ligand press release of Aug 3, 2020, Gloria Biosciences submitted a marketing application for OmniAb-derived zimberelimab, but no country is specified Feb 2020: Arcus Biosciences announced Taiho’s exercise of its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus Biosciences for commercialization in Japan and certain other territories in Asia (excluding China). NCT04262856 in NSCLC recruiitng as of Jan 2020. NCT03972722 Phase 2 study started in May 2019. NCT03629756 Phase 1 study started in July 2018. Clinical trial information: N+W947CT03655483 (J Clin Oncol 37, 2019 (suppl; abstr e14072); https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.4_suppl.125). NCT03655483 Phase 2 study in Hodgkin lymphoma started in Aug 2018. Nov 2017: The proceeds from this financing will be used for the advancement of Arcus’s clinical programs for AB928, a first-in-class dual adenosine receptor antagonist, and AB122, a PD-1 antibody. Earlier this month, Arcus initiated a phase 1 trial of AB928 in healthy volunteers and Arcus plans to initiate a phase 1/2 trial of AB928 in combination with AB122 in cancer patients during the first half of 2018. Also in November, Arcus initiated a phase 1 trial of AB122 in cancer patients in Australia. Data from the AB122 trial will be available in 2018 and Arcus plans to evaluate AB122 in combination with its other product candidates, in addition to AB928, in the future. The proceeds raised will also allow Arcus to advance at least two additional product candidates into clinical development, including AB680, a first-in-class small molecule CD73 inhibitor, and AB154, a TIGIT antibody. Aug 18, 2017 Ligand press release: WuXi Biologics was contracted by its Chinese partner Harbin Gloria Pharmaceuticals to discover and develop GLS-010 using Ligand’s OmniAb® technology, specifically the OmniRat® transgenic rat platform. GLS-010 is currently being evaluated in cancer patients in Phase 1 clinical studies in China. WuXi Biologics subsequently licensed their exclusive rights to the anti-PD-1 antibody GLS-010 to Arcus Biosciences in North America, Europe, Japan and certain other territories. |
| Full address of company | Hong Kong Asia China https://www.forbes.com/companies/harbin-gloria-pharmaceuticals/?sh=591924c84888 |
Immune checkpoint target. AB122, a fully human monoclonal antibody targeting PD-1 (https://www.annalsofoncology.org/article/S0923-7534(19)32690-0/fulltext)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |