Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5, BNT317 DL6, BNT317 selected DLA, BNT317 selected DLB
BNT317 · 1 trial · 1 indication
Per dose group. During the DLT observation period.
Per dose group.
Per dose group.
Per dose group. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
| Arm | Type | Description |
|---|---|---|
| Part A - BNT317 DL1 | EXPERIMENTAL | BNT317 monotherapy |
| Part A - BNT317 DL2 | EXPERIMENTAL | BNT317 monotherapy |
| Part A - BNT317 DL3 | EXPERIMENTAL | BNT317 monotherapy |
| Part A - BNT317 DL4 | EXPERIMENTAL | BNT317 monotherapy |
| Part A - BNT317 DL5 | EXPERIMENTAL | BNT317 monotherapy |
| Part A - BNT317 DL6 (optional) | EXPERIMENTAL | BNT317 monotherapy |
| Part B1 - BNT317 selected DLA | EXPERIMENTAL | BNT317 monotherapy, DL as selected from Part A. |
| Part B1 - BNT317 selected DLB | EXPERIMENTAL | BNT317 monotherapy, DL as selected from Part A. |
| Part B2 - BNT317 selected DLA plus SoC chemotherapy 1 | EXPERIMENTAL | BNT317 combination therapy, DL as selected from Part A. |
| Part B2 - BNT317 selected DLB plus SoC chemotherapy 1 | EXPERIMENTAL | BNT317 combination therapy, DL as selected from Part A. |
| Part B3 - BNT317 selected DLB plus SoC chemotherapy 2 | EXPERIMENTAL | BNT317 combination therapy, DL as selected from Parts B1 and B2. |
| Name | Type | Description |
|---|---|---|
| BNT317 DL1 | BIOLOGICAL | Intravenous infusion |
| BNT317 DL2 | BIOLOGICAL | Intravenous infusion |
| BNT317 DL3 | BIOLOGICAL | Intravenous infusion |
| BNT317 DL4 | BIOLOGICAL | Intravenous infusion |
| BNT317 DL5 | BIOLOGICAL | Intravenous infusion |
| BNT317 DL6 | BIOLOGICAL | Intravenous infusion |
| BNT317 selected DLA | BIOLOGICAL | Intravenous infusion |
| BNT317 selected DLB | BIOLOGICAL | Intravenous infusion |
| SoC chemotherapy 1 | DRUG | Intravenous infusion |
| SoC chemotherapy 2 | DRUG | Intravenous infusion |
If not specified otherwise, criteria listed below are applicable for all parts. Key Inclusion Criteria: * Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not app...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BNT317 is an investigational monoclonal antibody being developed by BioNTech SE for the treatment of advanced solid tumors. It is a Phase 1 oncology candidate and has not been approved for any indication. The program includes multiple dose levels and selected dose regimens, referred to as BNT317 DL1 through DL6 and selected DLA and DLB.
BNT317 is being studied as a treatment for advanced solid tumors. It is an investigational therapy in Phase 1 clinical development, so it is not yet approved for use in advanced solid tumors or any other condition. The ongoing trial is evaluating safety and preliminary effectiveness in adults with advanced solid tumors.
BNT317 targets PD-L1, a protein that is part of the PD-L1 pathway. By binding to PD-L1, the monoclonal antibody is designed to interfere with a mechanism that tumors use to suppress immune responses. This is the mechanism under investigation in the Phase 1 program.
BNT317 is being developed by BioNTech SE, which trades under the ticker BNTX. BioNTech is the sponsor of the Phase 1 clinical trial evaluating BNT317 in advanced solid tumors. The company is responsible for the clinical development of the asset.
BNT317 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. The single ongoing trial is a Phase 1 study, and no completed trials of BNT317 have been reported.
BNT317 is being evaluated in one active clinical trial, NCT06750185, titled Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors. The Phase 1 trial is currently recruiting and plans to enroll 248 participants across the United States and Australia.
Yes. BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5, BNT317 DL6, BNT317 selected DLA, and BNT317 selected DLB are alternative names for BNT317. These labels refer to different dose levels and selected dose regimens within the same BioNTech development program for advanced solid tumors.