Lenvervimab Terminated Naked monospecific

Antibody Information

Entry ID	2064
INN	Lenvervimab
Status	Terminated
Drug code(s)	GC1102
Brand name	Hepabig-Gene
mAb sequence source	mAb human
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)	HBV (HBsAg)
Indications of clinical studies	Prevention of Hepatitis B virus infection recurrence after liver transplantation
Primary therapeutic area	Infectious diseases

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 2/3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	July 01, 2008
Start of Phase 2	February 15, 2015
Start of Phase 3	March 29, 2018
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	GC Biopharma
Licensee/Partner	None
Comments about company or candidate	GC Biopharma (formerly GC Pharma, formerly Green Cross Corporation) Not listed in company pipeline updated Jan 2022; Phase 2/3 study is active not recruiting but record has not been updated since Jan 2020. Still listed as Phase 2 in company pipeline information updated January 2020. Feb 2019: GC 1102 receives Orphan Drug status for Hepatitis B (Prevention, recurrence following liver transplantation) in European Union and US. NCT03801798 Phase 2 study started in Feb 2019. NCT03519113 Phase 2/3 study is a Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluate the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102. Listed as Phase 2 in company pipeline last updated Sep 2018. NCT02304315 Phase 2 study completed as of May 2016. NCT01606163 Phase 1 study started in Aug 2012 completed in Dec 2013.
Full address of company	107 Ihyeon-ro 30-beongil, Giheung-gu, Yongin-si, Gyeonggi-do Asia China http://m.globalgreencross.com/etc/request_input.do

Description/comment

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen. Humanized according to WHO's Proposed INN List 118, but described as human on Green Cross website. Preclinical results published in April 2019: https://www.journal-of-hepatology.eu/article/S0618-8278(19)30089-1/abstract

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None