Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | HBV (HBsAg) |
| Indications of clinical studies | Prevention of Hepatitis B virus infection recurrence after liver transplantation |
| Primary therapeutic area | Infectious diseases |
| 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 | 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 |
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
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |