Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 446 |
| INN | None |
| Status | Clinical |
| Drug code(s) | BL-M07D1 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Undisclosed |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor, Ed-04 |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma, Non-small cell lung cancer, Urinary and Digestive Tract Tumors, 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) | July 15, 2022 |
| Start of Phase 2 | |
| Start of Phase 3 | May 22, 2024 |
| 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 | Sichuan Baili Pharmaceutical Co. Ltd., Systimmune |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06423885 Phase 2 in HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma due to start in June 2024. NCT06316531 /CTR20240858 Phase 3 in breast cancer started in May 2024. NCT06131450 Phase 1/2 in gynecological malignancies due to start in Dec 2023. NCT06114511 Phase 1/2 in NSCLC due to start in Dec 2023 NCT06031584 Phase 1/2 in Her2-positive/Low-expression Urinary and Digestive Tract Tumors due to start in Nov 2023 NCT05631964 /CTR20222950 Phase 1 in digestive tract and other solid tumors started in Jan 2023. NCT05461768 / CTR20221789 is A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M07D1injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expression Breast Cancer and Other Solid Tumors started in Aug 2022 |
| Full address of company | 1#, Building 1,No.161, Baili Road, Cross-Strait Science and Technology Industrial Development Park, Wenjiang District, Chengdu City Postcode：610041 Asia China http://www.baili-pharm.com/ |
ADC BL-M07D1 is a HER2 specific antibody based on the drug Trastuzumab. Due to its HER2 binding, BL-M07D1 has anti-proliferative effects in a variety of HER2 driven solid tumors and secondarily, through a wt FC receptor can mediate innate immune effector functions toward the cancer cells. Upon antibody mediated internalization, BL-M07D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death. https://systimmune.com/bl-m07d1
| Anticipated events | Phase 2 pending |
| Factor(s) contributing to discontinuation | None |