Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT165b1 · 1 trial · 1 indication
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: BNT165b1: 3 Micrograms (mcg) | EXPERIMENTAL | Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 2: BNT165b1: 10 mcg | EXPERIMENTAL | Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 3: BNT165b1: 30 mcg | EXPERIMENTAL | Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively. |
| Name | Type | Description |
|---|---|---|
| BNT165b1 | BIOLOGICAL | RNA vaccine for active immunization against malaria administered as intramuscular injection. |
| Placebo | OTHER | Placebo matched to RNA vaccine administered as intramuscular injection. |
Inclusion Criteria: * Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures * Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to follow good pract...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
BNT165b1 is an investigational monoclonal antibody being developed for the prevention of malaria. It is in Phase 1 clinical development and is not approved for any indication. BioNTech SE is developing it as part of its infectious disease pipeline.
BNT165b1 targets the circumsporozoite protein (CSP), a protein found on the surface of the malaria parasite. By binding to CSP, the monoclonal antibody is designed to interfere with the parasite's ability to infect liver cells. This target class is a protein.
BNT165b1 is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the clinical program for this malaria monoclonal antibody.
BNT165b1 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed.
BNT165b1 has been studied in one clinical trial, NCT05581641, titled "Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria." This Phase 1 trial enrolled 60 healthy adult volunteers in the United States and is now completed.
Yes, the Phase 1 trial NCT05581641 was randomized, double-blind, and placebo-controlled. It enrolled 60 healthy volunteers aged 18 years and older in the United States. The trial has been completed.