BioNTech SE Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-08-31: Study NCT07798648; Company role Lead sponsor; Phase Phase 3; Status Not yet recruiting.
- 2026-08-04: Study NCT07698600; Company role Lead sponsor; Phase Phase 1; Status Recruiting.
- 2026-07-23: Study NCT07730450; Company role Lead sponsor; Phase Phase 4; Status Recruiting.
- 2026-04-22: Study NCT07365995; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-08-31 | NCT07798648 A Study of COVID-19 Vaccine(s) in Children and Adults | Lead sponsor | Phase 3 | Not yet recruiting | COVID-19 Vaccines | 700 | 2027-04-20 |
| 2026-08-04 | NCT07698600 A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV | Lead sponsor | Phase 1 | Recruiting | HIV -1 Infection | 126 | 2028-02 |
| 2026-07-23 | NCT07730450 A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age | Lead sponsor | Phase 4 | Recruiting | COVID-19 Vaccines | 200 | 2027-08-20 |
| 2026-04-22 | NCT07365995 A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer | Lead sponsor | Phase 3 | Recruiting | Metastatic Castration-resistant Prostate Cancer | 736 | 2031-02 |
| 2026-03-30 | NCT07455734 Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors | Lead sponsor | Phase 1, Phase 2 | Recruiting | Advanced Solid Tumor Cancer | 533 | 2030-10 |
| 2026-03-26 | NCT07293351 A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) | Collaborator Lead: Bristol-Myers Squibb | Phase 1, Phase 2 | Recruiting | Advanced Renal Cell Carcinoma (RCC) | 474 | 2031-11-26 |
| 2026-03-16 | NCT07361497 A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) | Collaborator Lead: Bristol-Myers Squibb | Phase 3 | Recruiting | Non-small Cell Lung Cancer (NSCLC) | 850 | 2033-12-31 |
| 2026-03-16 | NCT07291076 A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) | Collaborator Lead: Bristol-Myers Squibb | Phase 1, Phase 2 | Recruiting | Hepatocellular Carcinoma (HCC) | 198 | 2031-10-14 |
| 2026-03-13 | NCT07221149 A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) | Collaborator Lead: Bristol-Myers Squibb | Phase 2, Phase 3 | Recruiting | Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma | 690 | 2032-09-11 |
| 2026-03-12 | NCT07361510 A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) | Collaborator Lead: Bristol-Myers Squibb | Phase 3 | Recruiting | Non-Small Cell Lung Cancer (NSCLC) | 750 | 2031-10-14 |
| 2026-02-20 | NCT07379580 A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa | Lead sponsor | Phase 2 | Recruiting | Mpox (Monkeypox); Smallpox; Orthopoxvirus Infection | 310 | 2027-06 |
| 2026-02-09 | NCT07392372 A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV | Lead sponsor | Phase 1 | Recruiting | HIV -1 Infection | 67 | 2027-06 |
| 2026-01-15 | NCT07297212 A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma | Lead sponsor | Phase 2 | Recruiting | Recurrent Glioblastoma | 75 | 2029-07 |