Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1122 |
| INN | None |
| Status | Clinical |
| Drug code(s) | PM8002, BNT327 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Bispecific |
| Format, general category | Appended Ig |
| Format details | VHH-IgG |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Camelid-derived |
| Target(s) | PD-L1, VEGF |
| Indications of clinical studies | Hepatocellular carcinoma, Small cell lung cancer, Non-small cell lung cancer, 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) | October 15, 2020 |
| Start of Phase 2 | July 01, 2022 |
| Start of Phase 3 | June 15, 2023 |
| 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 | BioNTech |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 13 2024: BioNTech SE and Biotheus Inc. announced the signing of a definitive agreement for the acquisition of Biotheus. NCT06616532 Phase 3 in SCLC due to start in Oct 2024. NCT06419621 Phase 3 in triple-neg breast cancer started in June 2024. Nov. 6, 2023 /Biotheus Inc. announced that the company has entered into an exclusive global license and collaboration agreement under which BioNTech will be developing, manufacturing and commercializing PM8002 globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China. NCT05844150 Phase 2/3 in SCLC started in June 2023 NCT05756972 Phase 2/3 in NSCLC start in June 2023 Listed as in Phase 2 on company website accessed Dec 21, 2022 Listed as in Phase 1 on company website accessed Jan 21, 2022 |
| Full address of company | Unit 10-B, Building 4, No.1, Keji 7th Road, Tangjiawan Town, High-Tech Zone, Zhuhai City, Guangdong Province Asia China https://www.biotheus.com/contact.html |
PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |