Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1018 ISS immunostimulatory oligonucleotide with HBV surface antigen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Low dose |
| 2 | EXPERIMENTAL | Middle dose |
| 3 | EXPERIMENTAL | High dose |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen | BIOLOGICAL | Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8 |
| Hepatitis B Vaccine (Recombinant) | BIOLOGICAL | IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24 |
Inclusion Criteria: * Willing and able to give written informed consent * Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis * Body ...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
It is an investigational hepatitis B vaccine candidate that combines an immunostimulatory oligonucleotide, 1018 ISS, with hepatitis B virus surface antigen. Dynavax Technologies Corporation (DVAX) is developing it for the prevention of hepatitis B infection. It has been studied in a Phase 1 clinical trial.
It is being developed for hepatitis B, an infectious disease of the liver. The candidate is intended to stimulate an immune response against hepatitis B virus surface antigen. Its only recorded clinical trial enrolled adults with end-stage kidney failure, a group with reduced vaccine responses.
Dynavax Technologies Corporation, which trades on Nasdaq under the ticker DVAX, is the developer of 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen. The company sponsored the Phase 1 trial of the candidate in the United States.
1018 ISS immunostimulatory oligonucleotide with HBV surface antigen is in Phase 1 development. It is investigational and has not been approved for any indication. One Phase 1 trial has been completed, and no trials are currently active.
The candidate has been studied in one completed Phase 1 trial, NCT00426712, titled Safety of HEPLISAV Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients. It was an active-controlled, randomized trial that enrolled 42 participants in the United States, including adults aged 40 years and older.