Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1887 |
| INN | None |
| Status | Terminated |
| Drug code(s) | BAT8001, BAT-8001 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | 6‐maleimidocaproic acid (non-cleavable linker) |
| Ave. DAR | 3.5 |
| Conjugated/fused moiety | Tubulin inhibitor, Maytansinoid |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Breast cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | March 17, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | July 01, 2018 |
| 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 |
| Licensee/Partner | None |
| Comments about company or candidate | In February 2021, the company officially announced the preliminary statistical analysis of the BAT8001 phase III clinical trial. The main efficacy index of PFS in the BAT8001 treatment group was compared with that in the control group (lapatinib combined with capecitabine) but did not achieve the preset superiority target, and the results were unsatisfactory. Phase 3 study was discussed at AACR Annual Meeting 2019; March 29-April 3, 2019: Currently, a Phase 3, multicenter, randomized, open-label, controlled trial evaluating the efficacy and safety of BAT8001 has been initiated in patients with HER2+ metastatic breast cancer who previously received trastuzumab separately or in combination with taxanes. The trial is designed to compare BAT8001 versus lapatinib combined with capecitabine which is 2nd-line standard of care for metastatic breast cancer patients in China. This Phase 3 trial plans to recruit approximately 410 patients and by Jan 2019 more than 130 patients have received the treatment of BAT8001. The BAT8001 benefit-risk profile continues to support further development and the clinical results will be revealed by early 2020. (https://cancerres.aacrjournals.org/content/79/13_Supplement/CT053). BAT8001 and its related technology and products have been granted numerous patents both in China and the US. BAT8001 is backed by provincial and municipal committees for Science and Technology Key Projects, and has been recommended for priority review by the NHFPC's Significant New Drug Expert Panel. BAT8001 is in Phase 3 clinical evaluation for the treatment of HER2-positive, metastatic breast cancer who previously received trastuzumab separately or in combination treatment. CTR20181946 started in Aug 2019. NCT04185649 / CTR20180157 Phase 3 in breast cancer started in Aug 2018 CTR20170072 Phase 1 in HER2+ solid tumors started in Mar 2017. |
| 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 |
HER2-targeted antibody-drug conjugate (ADC) which contains the humanized anti-HER2 IgG1, covalently linked to the maytansine derivative via conjugation to a stable linker; listed as an innovative molecule on the Bio-Thera Solutions website. DAR 3.5 BAT8001 is the first ADC in Bio-Thera’s pipeline.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |