Becotatug vedotin Regulatory review ADC

Antibody Information

Entry ID	1029
INN	Becotatug vedotin
Status	Regulatory review
Drug code(s)	MRG003
Brand name	(Pending)
mAb sequence source	mAb humanized
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	Valine-Citrulline (Cleavable linker)
Ave. DAR	___
Conjugated/fused moiety	Tubulin inhibitor, Monomethyl auristatin E (MMAE)
Discovery method/technology	None

Therapeutic information

Target(s)	EGFR
Indications of clinical studies	Gastric cancer, Nasopharyngeal Carcinoma, Biliary Tract Cancer, Non-small cell lung cancer, Colorectal cancer, head and neck 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)	Regulatory review China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 09, 2018
Start of Phase 2	September 15, 2020
Start of Phase 3	April 15, 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 information

Company	LEPU Biopharma, Shanghai Miracogen Inc.
Licensee/Partner	None
Comments about company or candidate	Mar 2025: Based on the latest communication between the Company and the authority, in order to submit relevant supplementary information, the Company has voluntarily withdrawn the previous NDA of MRG003, and has already supplemented relevant application materials and prepared the eCTD documents. The Company will resubmit an NDA for MRG003 on March 4, 2025 and will use its best endeavors to work with the authority in its subsequent review procedures to obtain the NDA approval. https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0304/2025030400050.pdf Sep 27, 2024: Lepu announces that we have received the Acceptance Notice issued by China National Medical Products Administration in relation to the acceptance of the New Drug Application of our drug candidate MRG003 for the treatment of recurrent or metastatic nasopharyngeal cancer. MRG003 has also been granted priority review by the Center for Drug Evaluation. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0927/2024092700183.pdf July 2024: MRG003: Owing to the encouraging clinical data, MRG003 was granted BTD by the FDA. Overall, MRG003 was granted BTD, ODD and FTD on NPC from the FDA and BTD from the CDE. Plan marketing application in 2024 (https://en.lepubiopharma.com/upload/listedco/listconews/sehk/2024/0821/2024082100594.pdf; https://en.lepubiopharma.com/upload/2024-04/171404093115884900.pdf) NCT05751512 Phase 3 in Squamous Cell Carcinoma of the Head and Neck to start in Mar 2023; CTR20223356 first patient dosed on April 4, 2023. MRG003 has been granted ODD from FDA and BTD from CDE in September 2022 for the treatment of NPC. Five Phase 2 studies recruiting as of June 2022. NCT04838964 Phase 2 in Biliary Tract Cancer due to start in April 2021. NCT04838548 Phase 2 in NSCLC started in Sep 2020; NCT05188209 Phase 2 in gastric cancer started in May 2021. Clinical studies in China
Full address of company	No.651, Lianheng Road, Minhang District, Shanghai, CHINA Asia China https://en.lepubiopharma.com/contact/shanghai

Description/comment

MRG003 is a novel antibody drug conjugate (ADC) composed of a fully human anti-EGFR IgG1 monoclonal antibody conjugated to a microtubule disrupting agent monomethyl auristatin E (MMAE). MRG003 is presently being tested in an ongoing phase I study for safety, pharmacokinetics, and preliminary antitumor activity in patients (pts) with solid tumors (CTR20180310). https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3550.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None