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BNT116 · 1 trial · 1 indication
Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
According to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 1B - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants) | EXPERIMENTAL | - |
| Cohort 3 - BNT116 + Docetaxel | EXPERIMENTAL | - |
| Cohort 4 - BNT116 + Cemiplimab (Frail Participants) | EXPERIMENTAL | - |
| Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT]) | EXPERIMENTAL | - |
| Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel | EXPERIMENTAL | BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab |
| Cohort 7 - BNT116 + BNT316 | EXPERIMENTAL | Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316 |
| Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established. |
| Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT. |
| Cohort EGFR : BNT116 + osimertinib | EXPERIMENTAL | Dose confirmation for BNT116 in combination with ongoing osimertinib therapy. Treatment with osimertinib is standard of care. Cohort will enroll only at selected sites in the US. |
| Cohort ALK/RET: BNT116 + ALK TKI or RET TKI | EXPERIMENTAL | Dose confirmation for BNT116 in combination with either ongoing ALK-inhibitor or ongoing RET-inhibitor therapy. Treatment with ALK TKI or RET TKI is standard of care. Cohort will enroll only at selected sites in the US. |
| Name | Type | Description |
|---|---|---|
| BNT116 | BIOLOGICAL | Intravenous injection |
| Cemiplimab | BIOLOGICAL | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Carboplatin | DRUG | Intravenous infusion |
| Paclitaxel | DRUG | Intravenous infusion |
| BNT316 | BIOLOGICAL | Intravenous infusion |
| anti-B7-H3 antibody conjugated to topoisomerase I inhibitor | BIOLOGICAL | Intravenous infusion |
| anti-HER3 antibody conjugated to topoisomerase I inhibitor | BIOLOGICAL | Intravenous infusion |
| Bispecific antibody for PD-L1 and VEGF-A | BIOLOGICAL | Intravenous infusion |
| Osimertinib | BIOLOGICAL | Oral |
| ALK-inhibitor or RET-inhibitor | BIOLOGICAL | Oral |
Key Inclusion Criteria: * Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 as well as in Cohorts EGFR and ALK/RET do not have to present with measurable disease. 1. Participants must present with unresectable S...
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BNT116 is an investigational monoclonal antibody being developed for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is currently being evaluated in a Phase 1 clinical trial for patients with advanced NSCLC, both as a monotherapy and in combination with other treatments.
BNT116 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial to evaluate the safety, tolerability, and preliminary efficacy of BNT116 in patients with advanced Non-Small Cell Lung Cancer.
BNT116 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety, tolerability, and preliminary efficacy of BNT116 in patients with advanced Non-Small Cell Lung Cancer.
BNT116 is being studied in a single Phase 1 clinical trial with the identifier NCT05142189. This trial is evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced Non-Small Cell Lung Cancer. The trial is currently recruiting and aims to enroll 320 participants.
BNT116 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing clinical trial is designed to evaluate its safety, tolerability, and preliminary efficacy, and it has not yet completed the clinical development process required for regulatory approval.