Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT113 · 2 trials · 8 indications
TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.
OS defined as the time from randomization to death from any cause.
PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.
Safe and tolerable dose of clinically disease free patients (Arm 1A) - Determination of a suitable dose of HPV RNA
| Arm | Type | Description |
|---|---|---|
| Part A (Safety Run-In) - BNT113 + Pembrolizumab | EXPERIMENTAL | Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. |
| Part B (Randomized phase) - BNT113 + Pembrolizumab | EXPERIMENTAL | BNT113 in combination with pembrolizumab. |
| Part B (Randomized phase) - Pembrolizumab monotherapy | ACTIVE_COMPARATOR | Pembrolizumab monotherapy. |
| RNA Vaccine A | EXPERIMENTAL | Arm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine. \- COMPLETE no longer recruiting |
| RAN Vaccine B | EXPERIMENTAL | Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine. OPEN to recruitment |
| Name | Type | Description |
|---|---|---|
| BNT113 | BIOLOGICAL | IV injection |
| Pembrolizumab | BIOLOGICAL | IV infusion |
Key Inclusion Criteria: * Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures. * Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies. * Patients who have a tumor t...
BNT113 is being developed for HPV-related cancers, specifically unresectable head and neck squamous cell carcinoma that is positive for human papillomavirus 16 and expresses the PD-L1 protein. It is also being studied in other HPV-related carcinomas, including cervical, penile, and unknown primary tumors.
BNT113 is being developed by BioNTech SE, a German biotechnology company that trades on the Nasdaq under the ticker BNTX. BioNTech is running the clinical program for BNT113 in HPV-positive head and neck cancer and other HPV-related malignancies.
BNT113 is in clinical development. It has been studied in a completed Phase 1 trial and is currently being evaluated in an active Phase 2 trial. BNT113 is investigational and has not been approved by the FDA for any indication.
BNT113 has been evaluated in two clinical trials. The Phase 2 trial NCT04534205 is testing BNT113 in combination with pembrolizumab versus pembrolizumab alone in HPV16-positive, PD-L1-expressing head and neck cancer, and it is active but not recruiting. The completed Phase 1 trial NCT03418480 studied BNT113 in HPV-related carcinomas.
Across its clinical program, 358 patients are enrolled in the Phase 2 trial NCT04534205, which is testing BNT113 plus pembrolizumab against pembrolizumab alone. The completed Phase 1 trial NCT03418480 enrolled 32 patients with HPV-related carcinomas, including head and neck, cervical, and penile neoplasms.
The Phase 2 trial NCT04534205 is running in the United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, and the United Kingdom. It enrolls adults 18 years and older with unresectable, metastatic, or recurrent head and neck cancer.