Coprelotamab Terminated Naked monospecific

Antibody Information

Entry ID	2059
INN	Coprelotamab
Status	Terminated
Drug code(s)	GB221
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	HER2
Indications of clinical studies	Breast cancer
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)	Terminated at Phase 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	November 07, 2011
Start of Phase 2
Start of Phase 3	November 24, 2016
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	Genor Biopharma Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	Genor Interim results 2024: Continued internal development of GB226 PD-1 and GB221, have been paused and pending further assessment of development strategy and resource allocation. (https://www.genorbio.com/media/1420/2024-interim-report-en.pdf) Jan 2023: The phase 3 study NCT04164615 for breast cancer has no updates since 2019. There is no mention of this molecule in Genor Biopharma in 2022 annual or interim results. March 2022: Listed as in pivotal study; March 2021 press release: Regarding key drug candidates in our portfolio treating breast cancer, we plan to file NDA to NMPA for Coprelotamab (GB221) in HER2+ breast cancer at Q4 of 2021. https://www.genorbio.com/en/media/corporate-news/genor-biopharma-releases-its-annual-results-for-2020/ CTR20190884 completed in Sep 2020 CTR20171510 Phase III clinical trial comparing the efficacy and safety of GB221 combined with docetaxel and trastuzumab combined with docetaxel in the first-line treatment of patients with HER2-positive metastatic breast cancer started in May 2018 NCT04164615 is A Randomized, Double-blind, Multi-center Phase 3 Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
Full address of company	1690 Zhangheng Road, Building 3, Pudong New District, Shanghai Asia China https://www.genorbio.com/en/contact/

Description/comment

Coprelotamab has a different allotype compared to trastuzumab.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None