Hep B Drug Watch
Viravaxx herewith gives explicit credit to the Hepatitis B Foundation as the author and publisher of this Drug Watch. Drug Watch is a unique service of the Hepatitis B Foundation, which the Foundation has published for the past 20 years, and which is updated every month.
Therapeutic Vaccines: stimulate the immune system
| VVX001 | Therapeutic vaccine | Viravaxx, Vienna, Austria | viravaxx.com | Phase II |
| NASVAC | Therapeutic vaccine | CIGB, Cuba | cigb.edu.cu/sobre-cigb/ | Phase III |
| GS-4774 | Therapeutic vaccine | Globelmmune with Gilead, USA | globeimmune.com | Phase II |
| HepTcell | Therapeutic vaccine | Altimmune, USA | altimmune.com | Phase II |
| VBI-2601 (BRII-179) | Therapeutic vaccine | VBI Vaccines, USA | vbivaccines.com | Phase II |
| VTP-300 | Therapeutic vaccine | Vaccitech, USA | vaccitech.co.uk | Phase I/II |
| CVI-HBV-002 | Therapeutic vaccine | Cha Vaccine Institute, S. Korea | en.chavaccine.com | Phase I/II |
| AIC 649 | Therapeutic vaccine | AiCuris, Germany | aicuris.com | Phase I |
| HB-110 | Therapeutic vaccine | Ichor Medical with Genexine, USA | ichorms.com | Phase I |
| JNJ 64300535 | Therapeutic vaccine | Janssen, Ireland | janssen.com | Phase I |
| CARG-201 | Therapeutic vaccine | CaroGen, USA | carogencorp.com | Phase I |
| Chimigen HBV | Therapeutic vaccine | Akshaya, Canada | akshayabio.com | Preclinical |
| HBV | Therapeutic vaccine | HOOKIPA Pharma, Austria, with Gilead | hookipapharma.com | Preclinical |
| TherVacB | Therapeutic vaccine | Helmholtz Zentrum Muenchen, Germany | dzif.de/en/hepatitis | Preclinical |
| PRGN-2013 | Therapeutic vaccine | Precigen | precigen.com | Preclinical |
| ISA104 | Therapeutic vaccine | ISA Pharma, The Netherlands | isa-pharma.com | Preclinical |
| VRON-0200 | Therapeutic vaccine | Viron Therapeutics, USA | viriontx.com | Preclinical |
| HBV Vaccine | Therapeutic vaccine | Clear B Therapeutics, USA and Australia | clearbtherapeutics.com | Preclinical |
Nucleoside analogues (NUC’s): Interfere with viral DNA polymerase used for HBV replication
| Hepsera (Adefovir dipivoxil) | Inhibits viral DNA polymerase | Gilead Sciences, USA | gilead.com | Approved 2002 |
| Baraclude (Entecavir) | Inhibits viral DNA polymerase | Bristol-Myers Squibb, USA | bms.com | Approved 2005 |
| Tyzeka (Telbivudine) | Inhibits viral DNA polymerase | Novartis, USA | novartis.com | Approved 2006 |
| Viread (Tenofovir) | Inhibits viral DNA polymerase | Gilead Sciences | gilead.com | Approved 2008 |
| Vemlidy (TAF or tenofovir alfenamide) | Prodrug of Tenofovir | Gilead Sciences | gilead.com | Approved 2016 |
| Levovir (Cledvudine) | Inhibits viral DNA polymerase | Bukwang, S. Korea | bukwang.co.kr | Approved 2006 in S. Korea |
| Besivo (formerly ANA 380/LB80380) | Inhibits viral DNA polymerase | Ildong Pharma, S. Korea | ildong.com | Approved 2017 in S. Korea |
| Zadaxin | Immunomodulator | SciClone, USA | sciclone.com | Approved outside USA |
| ATI-2173 (Clevudine prodrug) | Inhibits HBV polymerase | Antios Therapeutics, USA | antiostherapeutics.com | Phase II |
Silencing RNA: Interferes and destroys viral RNA
| VIR-2218 | RNAi gene silencer | Vir Biotech, USA | vir.bio | Phase II |
| RG6346 (DCR HBVS) | RNAi gene silencer | Roche, Switzerland, with Dicerna | roche.com | Phase II |
| JNJ-3989 (ARO-HBV) | RNAi gene silencer | J&J with Arrowhead, USA | arrowheadpharma.com | Phase II |
| AB-729 | RNAi gene silencer | Arbutus Biopharma, USA | arbutusbio.com | Phase I |
| BB-103 | RNAi gene silencer | Benitec, Australia | benitec.com | Preclinical |
| ALG-125097 | RNAi gene silencer | Aligos Therapeutics, USA | aligos.com | Preclinical |
Capsid Inhibitors: Interfere with the viral DNA protein shield
| Vebicorvir (ABI-H0731) | Capsid inhibitor | Assembly Biosciences, USA | assemblybio.com | Phase II/III |
| Morphothiadin | Capsid inhibitor | HEC Pharma, PR China | pharm.hec.cn/en/ | Phase II |
| JNJ 56136379 | Capsid inhibitor | Janssen, Ireland | janssen.com | Phase II |
| ABI-H2158 | Capsid inhibitor | Assembly Biosciences, USA | assemblybio.com | Phase II |
| EDP-514 | Capsid inhibitor | Enanta, Pharma, USA | enanta.com | Phase II |
| RG7907 | Capsid inhibitor | Roche, Switzerland | roche.com | Phase I |
| QL-007 | Capsid inhibitor | Qilu, PR China | en.qilu-pharma.com | Phase I |
| ABI-H3733 | Capsid inhibitor | Assembly Biosciences, USA | assemblybio.com | Phase I |
| ZM-H1505R | Capsid inhibitor | ZhiMeng Biopharma, PR China | core-biopharma.com | Phase I |
| ALG-000184 | Capsid inhibitor | Aligos Therapeutics, USA | aligos.com | Phase I |
| B-836 | Capsid Inhibitor | Arbutus, USA | arbutusbio.com | Phase I |
| VNRX-9945 | Capsid Inhibitor | Venatorx, USA | venatorx.com | Phase I |
| GLP-26 | Capsid inhibitor | Emory University, USA | emory.edu | Preclinical |
HBV surface antigen Inhibitors: Interfere with HBV surface antigen production
| REP 2139 | sAg inhibitor | Replicor, Canada | replicor.com | Phase II |
| REP 2165 | sAg inhibitor | Replicor, Canada | replicor.com | Phase II |
| ALG-10133 | sAg inhibitor | Aligos Therapeutics, USA | aligos.com | Phase I |
Antisense: Binds to viral messenger RNA and inhibits viral protein production
| ONIS-HBVRx (GSK 3228836) | Prevent viral protein production | Ionis with GSK, USA | ionispharma.com | Phase II |
| ALG-020572 | Prevent viral protein production | Aligos Therapeutics, USA | aligos.com | Preclinical |
Gene Editing: destroy or repress HBV DNA
| EBT107 | CRISPR/Cas 9 | Excision Bio, USA | excisionbio.com | Preclinical |
| HBV | ARCUS platform | Precision Bio, USA | precisionbiosciences.com | Preclinical |
Monoclonal Antibodies: Neutralize HBV proteins to reduce infection
| GC1102 | Monoclonal antibody | Green Cross, South Korea | globalgreencross.com | Phase II |
| Vir-3434 | Monoclonal antibody | Vir Biotech, USA | vir.bio | Phase I |
Checkpoint Inhibitors: Stimulate T-cell recognition of HBV-Infected cells
| ASC22 | PDL1 inhibitor | Ascletis Pharma, PR China | ascletis.com | Phase II |
| GS 4224 | PDL1 inhibitor | Gilead, USA | gilead.com | Phase I |
Activators of the innate immune system
| Selgantolimod (GS9688) | TLR-8 agonist | Gilead Sciences, USA | gilead.com | Phase II |
| RG7854 | TLR-7 agonist | Roche, Switzerland | roche.com | Phase I |
| SBT 8230 | TLR-8 agonist | Silverback Therapeutics, USA | silverbacktx.com | Preclinical |
| YS-HBV-002 | Activator of TLR3, RIG1, MDA5 | YiSheng Biopharma, China | yishengbio.com | Preclinical |
| IMC-I109V | T-cell Receptor | Immunocore | immunocore.com | Phase II |
| LTCR-H2-1 | T Cell. immunotherapy | Lion TCR, Singapore | liontcr.com | Preclinical |
Other Investigational HBV Drugs
| APG-1387 | Apoptosis inducer | Ascentage, PR China | ascentagepharma.com | Phase II |
| EYP001 | FXR agonist | Enyo Pharma, France | enyopharma.com | Phase I |
| HBV | MicroRNA | Regulus, USA | regulusrx.com | Preclinical |
| ENOB-HB-01 | Gene modified cell therapy | Enochian Bio, USA | enochianbio.com | Preclinical |
| GV1001 | “Novel peptide” | GemVax & KAEL, South Korea | gemvax.com | Preclinical |
| CP101 | Oral microbiotic | Finch Therapeutics, USA | finchtherapeutics.com | Preclinical |
| EDP-721 | RNA destabilizer | Enanta Pharma, USA | enanta.com | Preclinical |
| DF-006 | Small molecule | Drug Farm, Shanghai | drug-farm.com | Preclinical |
| ASC42 | FXR agonist | Ascletis, Hong Kong | ascletis.com | Preclinical |
Interferons: Mimic naturally produced immunomodulators
| Intron A (Interferon alfa 2b) | Immunomodulator | Merck, USA | merck.com | Approved 1991 |
| Pegasys (Peginterferon alfa 2a) | Immunomodulator | Genentech, USA | genentech.com | Approved 2005 |