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BioNTech

BioNTech logo
🇩🇪Germany
Ownership
Public
Employees
6.1K
Market Cap
$20.7B
Website
http://www.biontech.de
Introduction

BioNTech SE operates as immunotherapy company, which engages therapies for cancer and other serious diseases. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Oezlem Tuereci, and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Phase 2
Recruiting
Conditions
Locally Advanced Breast Cancer
Triple Negative Breast Cancer
Metastatic Triple Negative Breast Cancers
Interventions
Drug: BNT327 Dose Level 1 (DL1)
Drug: BNT327 Dose Level 1 (DL2)
Drug: Nab-placlitaxel
Drug: BNT327 Optimized Dose
Drug: BNT327 Equivalent Q3W Dose
First Posted Date
2024-06-07
Last Posted Date
2025-05-02
Lead Sponsor
BioNTech SE
Target Recruit Count
70
Registration Number
NCT06449222
Locations
🇹🇷

Gazi University Medical Faculty, Yenimahalle, Turkey

🇺🇸

Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center, Palo Alto, California, United States

🇺🇸

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), New Brunswick, New Jersey, United States

and more 63 locations

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

Phase 2
Active, not recruiting
Conditions
Extensive-stage Small-cell Lung Cancer
Small-cell Lung Cancer
Interventions
Drug: BNT327 Dose Level 1 (DL1)
Drug: BNT327 Dose Level 2 (DL2)
First Posted Date
2024-06-07
Last Posted Date
2025-05-01
Lead Sponsor
BioNTech SE
Target Recruit Count
110
Registration Number
NCT06449209
Locations
🇦🇺

Peninsula Oncology Centre, Frankston, Australia

🇹🇷

Hacettepe University Medical Faculty Oncology Hospital, Ankara, Turkey

🇹🇷

Memorial Ankara Hospital, Ankara, Turkey

and more 62 locations

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Phase 3
Not yet recruiting
Conditions
Endometrial Cancer
Interventions
First Posted Date
2024-04-01
Last Posted Date
2025-04-10
Lead Sponsor
BioNTech SE
Target Recruit Count
504
Registration Number
NCT06340568

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

Phase 3
Completed
Conditions
Influenza
COVID-19
Interventions
Biological: Licensed influenza vaccine
Biological: Influenza and COVID-19 Combination A
Biological: Influenza and COVID-19 Combination B
Biological: Investigational influenza vaccine
Biological: Placebo
First Posted Date
2023-12-21
Last Posted Date
2024-12-13
Lead Sponsor
BioNTech SE
Target Recruit Count
8798
Registration Number
NCT06178991
Locations
🇺🇸

Velocity Clinical Research, Cincinnati, Mt. Auburn, Cincinnati, Ohio, United States

🇺🇸

North Alabama Research Center, Athens, Alabama, United States

🇺🇸

Accel Research Sites - Birmingham Clinical Research Unit, Birmingham, Alabama, United States

and more 141 locations

Safety and Preliminary Efficacy of BNT314 with or Without an Immune Checkpoint Inhibitor in Cancer Patients with Malignant Solid Tumors

Phase 1
Recruiting
Conditions
Advanced Malignant Solid Tumor
Interventions
First Posted Date
2023-11-29
Last Posted Date
2024-11-27
Lead Sponsor
BioNTech SE
Target Recruit Count
360
Registration Number
NCT06150183
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇧🇪

GZA Ziekenhuizen, Antwerpen, Belgium

🇧🇪

CHU de Liège, Liege, Belgium

and more 11 locations

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

Phase 1
Terminated
Conditions
Pancreatic Cancer
Interventions
Drug: BNT321 Dose Level 1
Drug: BNT321 Dose Level 2
Drug: mFOLFIRINOX
Drug: BNT321 RP2D
First Posted Date
2023-10-06
Last Posted Date
2025-01-23
Lead Sponsor
BioNTech SE
Target Recruit Count
2
Registration Number
NCT06069778
Locations
🇺🇸

Valkyrie Clinical Trials, Los Angeles, California, United States

🇺🇸

Medical University of South Carolina (MUSC), Charleston, South Carolina, United States

A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Phase 1
Active, not recruiting
Conditions
Malaria
Interventions
Other: Placebo
First Posted Date
2023-10-06
Last Posted Date
2025-04-09
Lead Sponsor
BioNTech SE
Target Recruit Count
138
Registration Number
NCT06069544
Locations
🇺🇸

AMR Tempe, Tempe, Arizona, United States

🇺🇸

University of Maryland, Center for Vaccine Development, Baltimore, Maryland, United States

🇺🇸

AMR Las Vegas, Las Vegas, Nevada, United States

and more 2 locations

A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Phase 2
Completed
Conditions
SARS-CoV-2 Infection
COVID-19
Interventions
Biological: BNT162b2 (Omi XBB.1.5)
Biological: BNT162b2 (Omi JN.1)
Biological: BNT162b2 (Omi KP.2)
First Posted Date
2023-08-18
Last Posted Date
2025-03-28
Lead Sponsor
BioNTech SE
Target Recruit Count
1051
Registration Number
NCT05997290
Locations
🇺🇸

North Alabama Research Center, Athens, Alabama, United States

🇺🇸

Medical Affiliated Research Center, Huntsville, Alabama, United States

🇺🇸

Alliance for Multispecialty Research, LLC, Norfolk, Virginia, United States

and more 29 locations

A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines

Phase 1
Active, not recruiting
Conditions
Monkeypox
Interventions
First Posted Date
2023-08-14
Last Posted Date
2025-03-13
Lead Sponsor
BioNTech SE
Target Recruit Count
96
Registration Number
NCT05988203
Locations
🇺🇸

California Research Foundation, San Diego, California, United States

🇺🇸

Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States

🇺🇸

University of Washington Virology Research Clinic, Seattle, Washington, United States

and more 4 locations

A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children

Phase 1
Withdrawn
Conditions
COVID-19
Interventions
Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose
First Posted Date
2022-11-29
Last Posted Date
2024-03-18
Lead Sponsor
BioNTech SE
Registration Number
NCT05630352
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