M701 Clinical Bispecific

Antibody Information

Entry ID	965
INN	None
Status	Clinical
Drug code(s)	M701
Brand name	None
mAb sequence source	mAb chimeric
General Molecular Category	Bispecific
Format, general category	Fragment-Fc
Format details	YBODY
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	YBODY platform

Therapeutic information

Target(s)	EpCAM, CD3
Indications of clinical studies	Malignant Ascites Caused by Advanced Epithelial Solid Tumors, Gastrointestinal or Ovarian Cancer, malignant Pleural Effusions Caused by NSCLC, Malignant Ascites
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)	October 15, 2018
Start of Phase 2	November 15, 2021
Start of Phase 3	March 20, 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	Wuhan YZY Biopharma Co. Ltd.
Licensee/Partner	Chia Tai Tianqing Pharmaceutical Group Co Ltd
Comments about company or candidate	NCT06432296 Phase 3 in malignant ascities started in Mar 2024 NCT06266091 Phase 2 in Gastrointestinal or Ovarian Cancer started in Nov 2021. We completed a Phase I clinical trial of M701 in treating malignant ascites (MA) in January 2022. We are currently conducting a Phase II clinical trial to evaluate the efficacy of M701 in combination with systematic treatment in MA patients. In addition, we commenced a Phase Ib/II clinical trial of M701 in treating malignant pleural effusion (MPE) in China in November 2022. NCT05543330 Phase 1/2 due to start in Sep 2022. NCT04501744 Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability and PK/PD of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody Via Intraperitoneal Infusion in Malignant Ascites started in Oct 2018. IND filed in China in 2016.
Full address of company	Biolake, C2-1, No. 666 High-tech Avenue, Wuhan, Hubei, China Asia China https://en.yzybio.com/

Description/comment

Based on YBODY® platform, we have developed three T cell-engaging BsAbs, namely M701, M802 and Y150.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None