Recent Updates
Recently added Catalysts

BNT165e

Phase 1

Malaria | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Apr 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment163
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06069544A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against MalariaPHASE1 COMPLETED 163 — — Nov 13, 2023Mar 20, 2026Apr 15, 20265 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
Up to 7 days after each dose

For each cohort in participants receiving at least one dose of trial intervention.

Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle/joint pain, and fever) recorded up to 7 d after each dose
Up to 7 days after each dose

For each cohort in participants receiving at least one dose of trial intervention.

Frequency of participants with at least one adverse event occurring until 28 days after each dose
Up to 28 days after each dose

For each cohort in participants receiving at least one dose of trial intervention.

Frequency of participants with at least one medically attended adverse event occurring until 24 weeks after last received IMP dose
Up to 24 weeks after last received IMP dose

For each cohort in participants receiving at least one dose of trial intervention

Frequency of participants in each cohort with at least one serious adverse event occurring until 24 weeks after last received IMP dose
Up to 24 weeks after last received IMP dose

For each cohort in participants receiving at least one dose of trial intervention.

Secondary Endpoints
Descriptive statistics on antibody levels (including geometric means and 95% confidence interval) at assessed timepoints
Up to 365 days after last received IMP dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
BNT165eEXPERIMENTALEscalating dose levels
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BNT165eBIOLOGICALMulti-antigen RNA-based vaccine for active immunization against malaria administered as intramuscular injection
PlaceboOTHERIsotonic NaCl solution (0.9%)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Have given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures. * Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions and other requirements of ...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Malaria 8 trials
CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06069544TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06069544studyFirstPostDate: changed