Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 374 |
| INN | None |
| Status | Clinical |
| Drug code(s) | BAT1308 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Mismatch repair protein-deficient (dMMR) endometrial carcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2021 |
| Start of Phase 2 | December 13, 2023 |
| Start of Phase 3 | |
| 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 | Bio-Thera Solutions Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06321068 Phase 2/3 in endometial cancer started in Mar 2024 active not recruiting as of last update in Oct 2024.. NCT06123884 / CTR20232394 Phase 2/3 in cervical cancer started in Dec 2023. NCT05109650 Phase 1 in solid tumors due to start in December 2021. NCT05155722 Phase 1 started in Sep 2020 recruiting as of last update in Jan 2022. Bio-Thera Solutions, Ltd., a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers. |
| Full address of company | Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China Asia China https://www.bio-thera.com/plus/list.php?tid=67 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |