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BNT351

Phase 1

HIV -1 Infection | Small molecule | Infectious Disease |BioNTech SE|Last Updated: Mar 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07392372A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIVPHASE1 RECRUITING 61 — — Feb 9, 2026Jun 1, 2027Mar 19, 20263 United States, Germany
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Study Endpoints
Primary Endpoints
Parts A and B - Occurrence of at least one adverse event (AE)
From dosing to 56 days post-dose

Per part, by cohort/dose

Parts A and B - Occurrence of at least one serious AE (SAE)
From dosing through the end of study (up to a maximum of 279 days post-dose)

Per part, by cohort/dose

Parts A and B (except for Cohort A1) - Occurrence of infusion-related reactions (IRRs) Grade ≥2 (graded based on National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE] version 5.0 as specified in the protocol)
From the start of IV dosing through 72 hours after the start of IV dosing

Per part, by cohort/dose

Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration site
From dosing through 7 days post-dose

Per part, by cohort/dose

Parts A and B- Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/malaise, myalgia/arthralgia, fever)
From dosing through 7 days post-dose

Per part, by cohort/dose

Parts A and B- Assessment of area under the concentration-time curve of BNT351
From pre-dose to last quantifiable timepoint (up to a maximum of 279 days post-dose)

Per part, by cohort/dose

Parts A and B - Assessment of maximum concentration of BNT351
From dosing through 7 days post-dose

Per part, by cohort/dose

Part B - Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection as defined in the protocol
From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Occurrence of absolute CD4+ T cell count <350 cells/µL or CD4+ T cell count <15% of total lymphocyte count
From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiation
At 7, 14, 21, 28, 35, 42, 49, and 56 days post-dose
Part B - Maximum decrease from baseline in HIV log10 plasma viral load prior to cART initiation
From baseline up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Time from dosing to lowest viral load prior to cART initiation
From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Part B - Time from dosing to viral rebound defined as HIV-1 RNA viral load increase >0.75 log10 copies/mL from nadir (i.e., lowest HIV-1 RNA viral load from 7 days post-dose (Visit 3) and through pre-cART initiation)
From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
Secondary Endpoints
Parts A and B - Incidence of detectable BNT351 anti-drug antibodies in serum
From baseline until the end of study (up to a maximum of 279 days post-dose)
Part B - Magnitude of cluster of differentiation 4 positive (CD4+) T cell counts
At dosing, 28 and 56 days post-dose or at time of cART initiation (up to a maximum of 56 days post-dose)
Parts B - Change from baseline in CD4+ T cell count
At 28 days post-dose and at time of cART initiation (up to a maximum of 56 days post-dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A - Cohort A1EXPERIMENTALPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)
Part A - Cohort A2EXPERIMENTALPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Part A - Cohort A3EXPERIMENTALPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Part A - Cohort A4EXPERIMENTALPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Part B - Cohort B1EXPERIMENTALPLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.
Interventions
NameTypeDescription
BNT351DRUGIV infusion
PlaceboDRUGIV infusion
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria Part A: * Are HIV-1 and HIV-2 negative at Visit 0. * Starting at Visit 0 and continuously until the last planned visit in this study are individuals who: 1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behavior...

Countries:United StatesGermany
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07392372primaryCompletionDate: changed
LOWMay 24, 2026NCT07392372studyFirstPostDate: changed