Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT351 · 1 trial · 1 indication
Per part, by cohort/dose
Per part, by cohort/dose
Per part, by cohort/dose
Per part, by cohort/dose
Per part, by cohort/dose
Per part, by cohort/dose
| Arm | Type | Description |
|---|---|---|
| Part A - Cohort A1 | EXPERIMENTAL | PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1) |
| Part A - Cohort A2 | EXPERIMENTAL | PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1) |
| Part A - Cohort A3 | EXPERIMENTAL | PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1) |
| Part A - Cohort A4 | EXPERIMENTAL | PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1) |
| Part B - Cohort B1 | EXPERIMENTAL | PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier. |
| Part B - Cohort B2 | EXPERIMENTAL | PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier. |
| Name | Type | Description |
|---|---|---|
| BNT351 | DRUG | IV infusion |
| Placebo | DRUG | IV infusion |
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
BNT351 is an investigational small molecule being developed by BioNTech SE for HIV-1 infection. It is in Phase 1 clinical development and is designed to target the 4-1BB protein. The program is in early-stage testing, with one active trial currently recruiting participants.
BNT351 is being studied for use in HIV-1 infection. It is an investigational agent in Phase 1 development, and its safety and biological activity are being evaluated in adults living with and without HIV. It has not been approved for any indication.
BNT351 targets the 4-1BB protein, also known as CD137. 4-1BB is a costimulatory receptor, and BNT351 is a small molecule designed to engage this target. This mechanism is being explored in the context of HIV-1 infection.
BNT351 is being developed by BioNTech SE, a biotechnology company whose shares trade under the ticker BNTX. BioNTech is the sponsor of the Phase 1 clinical trial evaluating BNT351 in adults with and without HIV.
BNT351 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The ongoing Phase 1 trial is evaluating its safety and biological activity in adults living with and without HIV.
BNT351 is being evaluated in a single Phase 1 trial, NCT07392372, titled "A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV." The trial is recruiting, has an estimated enrollment of 67 participants, and is conducted in the United States and Germany.