Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT326 · 2 trials · 2 indications
During the DLT evaluation period by dose level
Defined as the percentage 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.
By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2).
By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2)
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) based on the investigator's assessment (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response. By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2).
During the DLT observation period.
Evaluation of Cmax without and in combination with the CYP inhibitors (± itraconazole or ± paroxetine). Treatment comparison using geometric mean ratio of Cycle 3 as compared with Cycle 2 as a reference.
Evaluation of AUC over the last 17-day dosing interval without and in combination with the CYP inhibitors (± itraconazole or ± paroxetine). Treatment comparison using geometric mean ratio of Cycle 3 as compared with Cycle 2 as a reference.
| Arm | Type | Description |
|---|---|---|
| Part 1 - BNT326 (DL1) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig, starting dose. In participants with second-line (or higher) 2L(+), squamous or non-squamous NSCLC, actionable genomic alterations (AGA)-negative/positive, any programmed death-ligand 1 (PD-L1). |
| Part 1 - BNT326 (DL2) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL3) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL1) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL2) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL3) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 3) - BNT326 (DL3) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 4) - BNT326 (DL1) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 5) - BNT326 (DL2) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 6) - BNT326 (DL3) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with first-line (1L) squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 3) - BNT326 (DL3) + pumitamig (DL1) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 4) - BNT326 (DL1) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 5) - BNT326 (DL2) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 6) - BNT326 (DL3) + pumitamig (DL2) | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2b (Cohort C, Arm 1) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or epithelial growth factor receptor (EGFR) activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort C, Arm 2) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort D1, Arm 1) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort D1, Arm 2) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort D1, Arm 3) - Pumitamig monotherapy | EXPERIMENTAL | Pumitamig monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DL used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort D2, Arm 1) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 2b (Cohort D2, Arm 2) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a. |
| Part 1 (Cohort 1A) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL1 or DL2 or DL3) in participants with cutaneous melanoma 2L+ |
| Part 1 (Cohort 1B) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL1 or DL2) in participants with NSCLC 2L+ AGA-negative |
| Part 1 (Cohort 1C) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL1 or DL2) in participants with NSCLC 2L+ EGFRm |
| Part 1 (Cohort 1D) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL2 or DL3) in participants with rare melanoma 2L+ |
| Part 1 (Cohort 1E) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL2) in participants with advanced solid tumors 2L+ |
| Part 1 (Cohort 1F, DDI) - BNT326 + itraconazole | EXPERIMENTAL | BNT326 (DL1 or DL2 or DL3) + itraconazole in participants with advanced solid tumors |
| Part 1 (Cohort 1F, DDI) - BNT326 + paroxetine | EXPERIMENTAL | BNT326 (DL1 or DL2 or DL3) + paroxetine in participants with advanced solid tumors |
| Part 1 (Cohort 1G) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL2 or DL3) in participants with cervical cancer 2L+ |
| Part 2 (Cohort 2A dose escalation) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL1 or DL2 or DL3) + pumitamig (DL1 or DL2) in participants with cutaneous melanoma 2L+. Optionally, combinations with lower doses of BNT326 and/or pumitamig may be explored. |
| Part 2 (Cohort 2A dose randomization/expansion) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL1 or DL2 or DL3) + pumitamig (DL3 or DL4 or DL 5) in participants with cutaneous melanoma 2L+. Optionally, combinations with lower doses of BNT326 and/or pumitamig may be explored. |
| Part 2 (Cohort 2B dose escalation) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL1 or DL2 or DL3) + pumitamig (DL1 or DL2) in participants with HER2-negative breast cancer (triple-negative breast cancer and hormone receptor-positive /HER2-negative breast cancer) 2L+/1L |
| Part 2 (Cohort 2B dose randomization/expansion) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL1 or DL2 or DL3) + pumitamig (DL3 or DL4 or DL 5) in participants with HER2-negative breast cancer (triple-negative breast cancer and hormone receptor-positive /HER2-negative breast cancer) 2L+/1L |
| Part 2 (Cohort 2C) - Optional - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 + pumitamig in participants with cutaneous melanoma 1L+ |
| Part 2 (Cohort 2D1) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL2) in participants with GC/GEJC 2L+ |
| Part 2 (Cohort 2D2) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL2 or DL3) + pumitamig (DL1 or DL2) in participants with GC/GEJC 2L+ |
| Part 2 (Cohort 2E1) - BNT326 monotherapy | EXPERIMENTAL | BNT326 (DL2) in participants with colorectal cancer 2L+ |
| Part 2 (Cohort 2E2) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 (DL2 or DL3) + pumitamig (DL1 or DL2) in participants with colorectal cancer 2L+ |
| Part 2 (Cohort 2F) - BNT326 + pumitamig | EXPERIMENTAL | Combination therapy of BNT326 with pumitamig in participants with cervical cancer 2L+ (BNT326 DL2 with pumitamig DL1 or DL2 or BNT326 DL3 with pumitamig DL1 or DL2) |
| Name | Type | Description |
|---|---|---|
| BNT326 | DRUG | intravenous (IV) infusion |
| Pumitamig | DRUG | IV infusion |
| Itraconazole | DRUG | Oral administration |
| Paroxetine | DRUG | Oral administration |
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older. * Have measurable disease defined by RECIST v1.1. * Have Eastern Cooperative Oncolog...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BNT326 is an investigational small molecule being studied for the treatment of advanced solid tumors and non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BNT326 targets HER3, a protein involved in tumor growth. By targeting HER3, the drug aims to interfere with cancer cell signaling. It is being evaluated alone and in combination with other investigational treatments in clinical trials.
BNT326 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting Phase 1 clinical trials to assess the safety and potential benefit of the drug.
BNT326 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing trials are designed to evaluate safety, tolerability, and preliminary efficacy.
BNT326 is being studied in two Phase 1 trials. NCT07070232 evaluates BNT326 alone or with BNT327 in advanced solid tumors, enrolling 1,438 participants. NCT07111520 tests BNT326 with BNT327 in non-small cell lung cancer, enrolling 880 participants. Both are recruiting.
No, BNT326 and BNT327 are different investigational drugs. BNT326 is the subject of study, while BNT327 is another investigational treatment used in combination with BNT326 in clinical trials for advanced solid tumors and non-small cell lung cancer.