YAbS







BL-M07D1 Clinical ADC

Antibody Information

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

Therapeutic information

Target(s) HER2
Indications of clinical studies Breast cancer, HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma, Non-small cell lung cancer, Urinary and Digestive Tract Tumors, Solid tumors
Primary therapeutic area Cancer

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
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 information

Company Sichuan Baili Pharmaceutical Co. Ltd., Systimmune
Licensee/Partner None
Comments about company or candidate NCT06830889 Phase 3 in breast cancer due to start in May 2025.
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/

Description/comment

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

Additional information

Anticipated events Phase 2 and 3 pending
Factor(s) contributing to discontinuation None