Hepabig-gene (lenvervimab) / GC Biopharma - LARVOL DELTA

Hepatitis B immunoglobulin inhibits the secretion of HBV via antigen-antibody precipitation in the multivesicular body. (PubMed, Am J Transl Res) - "Lenvervimab decreases HBsAg secretion, and HBsAg antibody precipitation in the multivesicular body may play an important role."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • RAB5A

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. (clinicaltrials.gov) - P3b | N=200 | Not yet recruiting | Sponsor: GC Biopharma Corp

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Tumor • Transplantation

Episode 1: Frontline Treatment of Renal Cell Carcinoma (Medscape) - "Rini: I think I must have first created it for a talk. And I remember that as all these data were coming out, it was a lot of data for the field. And of course, we're comparing across trials and doing all the things we say we shouldn't do....Pal: I personally think it's brilliant. I think it's a terrific resource. You are really entrenched in these data. It's something that we're seeing day in and day out in clinical practice."

Audio • Renal Cell Carcinoma

Mapping the conformational epitope of a therapeutic monoclonal antibody against HBsAg by in vivo selection of HBV escape variants. (PubMed, Hepatology) - "Selection of antibody-escape HBV variants in human chimeric mice works efficiently. Analysis of such emerging variants helps to identify anchor amino acid residues of the conformational epitope that are difficult to discover by conventional approaches."

Journal • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Transplantation

The release of viral particle from hepatitis B virus infected hepatocytes is inhibited by recombinant hepatitis B virus immunoglobulin (lenvervimab). (PubMed, Ann Hepatobiliary Pancreat Surg) - "Rab7 (multivesicular body marker) and lenvervimab, HBsAg were co-localized in PLC/PRF/5. The release of viral particle is suppressed by lenvervimab with antigen-antibody reaction in multivesicular body."

Journal • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cancer • Solid Tumor • RAB5A

A recombinant human immunoglobulin with coherent avidity to hepatitis B virus surface antigens of various viral genotypes and clinical mutants. (PubMed, PLoS One) - "Here, we characterized a recombinant human IgG1 type anti-S antibody named Lenvervimab regarding its binding property to a variety of cloned S antigens...In addition, mutations in the S gene sequence that confer drug resistance to the viral polymerase did not interfere with the antibody binding. These results support for a preventive use of the antibody against HBV infection."

Clinical • Journal • Hepatitis B • Hepatology • Infectious Disease

HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102 (clinicaltrials.gov) - P2/3; N=186; Active, not recruiting; Sponsor: Green Cross Corporation; Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients (clinicaltrials.gov) - P2a; N=42; Active, not recruiting; Sponsor: Green Cross Corporation; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed

A Prospective, Open-label, Dose-escalation, Single-center, Phase 1 study for Lenvervimab (GC1102), a new and safe human monoclonal antibody drug for chronic hepatitis B patients (APASL 2019) - "The tolerability and safety of lenvervimab are considered favorable in patients with CHB when using single and multiple administration of lenvervimab."

Clinical • P1 data

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients (clinicaltrials.gov) - P2a; N=40; Recruiting; Sponsor: Green Cross Corporation; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients (clinicaltrials.gov) - P2a; N=40; Not yet recruiting; Sponsor: Green Cross Corporation

Clinical • Combination therapy • New P2a trial