Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT163 · 1 trial · 1 indication
For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
For each DL per BNT163 dosing schedule and for the combined placebo group.
| Arm | Type | Description |
|---|---|---|
| Part A - BNT163 | EXPERIMENTAL | Escalating dose levels |
| Part A - Placebo | PLACEBO_COMPARATOR | Isotonic NaCl solution (0.9%) |
| Part B - BNT163 Dose 1 | EXPERIMENTAL | - |
| Part B - BNT163 Dose 2 | EXPERIMENTAL | - |
| Part C - BNT163 | EXPERIMENTAL | One fix dose level of BNT163 |
| Part C - Placebo | PLACEBO_COMPARATOR | Isotonic NaCl solution (0.9%) |
| Name | Type | Description |
|---|---|---|
| BNT163 | BIOLOGICAL | Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection |
| Placebo | OTHER | Placebo |
Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures. * Are aged 18 to 55 years, have a body mass index over 18.5 kg/m\^2 a...
BNT163 is an investigational vaccine designed to prevent genital herpes lesions caused by Genital Herpes Simplex Type 2. It is being studied in healthy volunteers and volunteers with recurrent genital herpes to evaluate its safety, tolerability, and immune responses.
BNT163 targets 4-1BB, a protein involved in immune cell activation. By targeting 4-1BB, the vaccine aims to generate an immune response that may prevent genital herpes lesions. It is a monoclonal antibody modality being developed for infectious disease.
BNT163 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. The company is conducting a Phase 1 clinical trial to study the vaccine's safety and immune responses in participants.
BNT163 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with an enrollment target of 318.
BNT163 is being studied in a Phase 1 clinical trial with the identifier NCT05432583. The trial is a randomized, double-blind, placebo-controlled study conducted in the United States, enrolling healthy volunteers and individuals with recurrent genital herpes.
BNT163 is an investigational vaccine specifically designed to prevent genital herpes lesions caused by Genital Herpes Simplex Type 2. It is not the same as other vaccines; it is a unique candidate being developed by BioNTech SE and is currently in Phase 1 testing.