Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 413 |
| INN | Ociperlimab |
| Status | Clinical |
| Drug code(s) | BGB-A1217 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | TIGIT |
| Indications of clinical studies | Diffuse Large B-cell Lymphoma, Non-small cell lung cancer, Esophageal Squamous Cell Carcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2019 |
| Start of Phase 2 | January 15, 2021 |
| Start of Phase 3 | June 15, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | BeiGene Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 3 studies for Non Small Cell Lung Cancer: NCT04866017 has been terminated, NCT04746924 is active non recruiting as of October 2024 Listed as Phase 3 in BeiGene pipeline dated Aug 2024 (https://www.beigene.com/wp-content/uploads/2023/04/2Q24-Pipeline-Slide-August2024.pdf), but no studies are recruiting patients. July 2023: On December 19, 2021, BeiGene Switzerland GmbH, a wholly-owned indirect subsidiary of BeiGene, Ltd. entered into an Option, Collaboration and License Agreement with Novartis Pharma AG, pursuant to which BeiGene Switzerland granted Novartis an exclusive time-based option to receive an exclusive license to develop, manufacture and commercialize the Company’s investigational TIGIT inhibitor ociperlimab in certain territories. On July 10, 2023, BeiGene Switzerland and Novartis entered into a Mutual Termination and Release Agreement to mutually terminate the Option Agreement, effective immediately. Pursuant to the Termination Agreement, BeiGene Switzerland regained full, global rights to develop, manufacture and commercialize ociperlimab. Phase 3 studies for Non-small cell lung cancer (NCT04746924, NCT04866017), sponsored bui BeiGene, are recruiting as of March 28, 2023. Phase 3 trial for NSCLC sponsored by Novartis is not yet recruiting as of March 30, 2023 (NCT05791097) As of June 2022 press release, company expected to Initiate additional pivotal clinical trials in 2022; and Announce data from Phase 1 trial (NCT04047862) cohorts in various solid tumor types in 2022.; no mention of submission timeline. June 17, 2021 I BeiGene, Ltd. announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene’s investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. NCT04746924 and NCT04866017 Phase 3 studies in NSCLC not yet recruiting when first posted. NCT04732494 Phase 2 in Esophageal Squamous Cell Carcinoma recruiting when first posted on Feb 1, 2021 NCT04047862 Phase 1 /1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors started Aug 15 2019. |
| Full address of company | 30 Science Park Road, Zhongguancun Life Science Park
Changping District, Beijing 102206 Asia China https://www.beigene.com/ |
BGB-A1217 is a humanized, IgG1 monoclonal antibody against TIGIT.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |