Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 444 |
| INN | Izalontamab brengitecan |
| Status | Clinical |
| Drug code(s) | BL-B01D1, BMS-986507 |
| Brand name | None |
| mAb sequence source | mAb chimeric/human |
| General Molecular Category | ADC, Bispecific |
| Format, general category | Appended Ig conjugate |
| Format details | 2+2 symmetric, IgG-(scFv)2 |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | Cathepsin B cleavable linker |
| Ave. DAR | 8 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, Ed-04 |
| Discovery method/technology | None |
| Target(s) | EGFR, HER3 |
| Indications of clinical studies | Glioblastoma, Small cell lung cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, Triple-neg breast cancer, Non-small cell lung cancer (EGFR wild-type), Esophageal squamous cell carcinoma, Cervical cancer, Nasopharyngeal Carcinoma, Non-small Cell Lung Cancer With EGFR-sensitive Mutations, Gynecological Malignant Tumor, Urinary tract cancer, Breast cancer, Gastrointestinal 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) | August 15, 2021 |
| Start of Phase 2 | April 15, 2023 |
| Start of Phase 3 | December 04, 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 | Sichuan Baili Pharmaceutical Co. Ltd., Systimmune |
| Licensee/Partner | Bristol Myers Squibb |
| Comments about company or candidate | Phase 3 studies for Nasopharyngeal carcinoma (NCT06118333 / CTR20233419); Esophageal Squamous Cell Carcinoma (NCT06304974), Small Cell Lung Cancer (NCT06500026), Non-small Cell Lung Cancer (NCT06382129, NCT06382116), Triple-Negative Breast Cancer (NCT06382142), HR+HER2- Breast Cancer (NCT06343948) are recruiting as of May-September 2024 NCT06304974 Phase 3 in esophageal squamous cell carcinoma started in Mar 2024. Dec 2023: BMS gains ex-China rights to the EGFRxHER3 bispecific BL-B01D1. NCT06118333 / CTR20233419 Phase 3 in Nasopharyngeal Carcinoma started in Dec 2023. NCT05990803 Phase 2 in cervical cancer due to start in Sep 2023. NCT05880706 Phase 2 due to start in July 2023. NCT05785039 Phase 2 started in April 2023. NCT05470348 Phase 1 started in July 2022. NCT05461768 Phase 1 recruiting when first posted on July 18, 2022; NCT05393427 Phase 1 started in Feb 2022. Dec 2021: Beacon reports Phase 1 was started; CTR20212923 NCT05194982 Phase 1 started in Nov 2021. On August 10, 2021, the clinical trial application of Bailey Pharmaceuticals BL-B01D1 was accepted by NMPA |
| 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/ |
BL-B01D1 is a bispecific antibody conjugate (ADC) developed by Bailey Pharmaceuticals, which can target EGFR and HER3 at the same time. It is planned to develop BL-B01D1 for the treatment of lung cancer, esophageal cancer, head and neck squamous cell carcinoma and other indications. BL-B01D1 is comprised of a bispecific antibody against EGFR/HER3 (SI-B001), a cathepsin B cleavable linker, and a novel topoisomerase I inhibitor agent (Ed-04), which is a derivative of the alkaloid camptothecin, driving cell cycle arrest at the S phase and subsequent apoptosis. BL-B01D1 achieves a high drug-to-antibody-ratio (DAR=8) with a highly stable linker. Cancer Res (2023) 83 (7_Supplement): 2642. doi.org/10.1158/1538-7445.AM2023-2642. The Fab arms and Fc domains are derived from cetuximab. https://www.bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/ESMO-2024-investor-presentation.pdf
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |