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BNT351

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

BNT351 · 1 trial · 1 indication

Phase 1 1
NCT07392372A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIVHIV -1 Infection
RECRUITING67 Analytics
PHASE1RECRUITING
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
HIV -1 Infection
NCT0739237267
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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 to 56 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 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 - Occurrence of at least one serious adverse event (SAE)
From dosing through end of study (up to a maximum of 279 days post-dose)
Parts A and B - Assessment of area under the concentration-time curve of BNT351, from pre-dose to last quantifiable timepoint (AUClast)
From pre-dose to last quantifiable timepoint (up to a maximum of 279 days post-dose)
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)
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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.
Part B - Cohort B2EXPERIMENTALPLWH 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 to 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

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 61 trials (matched to "HIV -1 Infection")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT07392372lastUpdatePostDate: changed
LOWSep 1, 2026NCT07392372lastUpdatePostDate: changed
LOWAug 12, 2026NCT07392372lastUpdatePostDate: changed
LOWAug 12, 2026NCT07392372lastUpdatePostDate: changed
LOWJun 22, 2026NCT07392372Enrollment: 61 → 67
LOWJun 22, 2026NCT07392372Enrollment: 61 → 67

Frequently asked questions about BNT351

What is BNT351 used for in HIV-1 Infection?

BNT351 is an investigational small molecule being developed for the treatment of HIV-1 Infection. It is currently in Phase 1 clinical development, with an active trial recruiting participants in the United States and Germany. The drug is being studied in adults living without and with HIV.

Who makes BNT351?

BNT351 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 evaluate the safety and biological activity of BNT351 in adults with and without HIV-1 infection.

What phase is BNT351 in?

BNT351 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A single Phase 1 trial is currently recruiting participants to assess its safety and biological activity in the context of HIV-1 infection.

What clinical trials is BNT351 in?

BNT351 is being studied in a Phase 1 clinical trial with the identifier NCT07392372. This randomized, double-blind, controlled trial is recruiting 67 participants in the United States and Germany. The study is investigating the safety and biological activity of BNT351 in adults living without and with HIV.

Is BNT351 the same as any other drug?

No alternative names for BNT351 have been disclosed. The drug is identified solely by its code name BNT351 in clinical trial registrations. It is a distinct investigational small molecule being developed by BioNTech SE for HIV-1 infection.