BioNTech

🇩🇪Germany

Country: 🇩🇪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.

Clinical Trials

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

Phase 1

Completed

Conditions: COVID-19
Influenza, Human

Interventions: Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5)
Biological: QIV
Biological: qIRV (22/23)
Biological: tIRV
Biological: bIRV

First Posted Date: 2022-10-27

Last Posted Date: 2024-10-18

Lead Sponsor: BioNTech SE

Target Recruit Count: 1019

Registration Number: NCT05596734

Locations: 🇺🇸
Panax Clinical Research, Miami Lakes, Florida, United States
🇺🇸
DBC Research USA, Pembroke Pines, Florida, United States
🇺🇸
Pioneer Heart Institute, Lincoln, Nebraska, United States

and more 50 locations

Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Phase 1

Completed

Conditions: Malaria

Interventions: Other: Placebo
Biological: BNT165b1

First Posted Date: 2022-10-14

Last Posted Date: 2024-10-01

Lead Sponsor: BioNTech SE

Target Recruit Count: 60

Registration Number: NCT05581641

Locations: 🇺🇸
Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States
🇺🇸
University of Maryland, Center for Vaccine Development, Baltimore, Maryland, United States
🇺🇸
Clinical Trials of Texas, Inc., San Antonio, Texas, United States

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers

Phase 1

Recruiting

Conditions: Tuberculosis

Interventions: Other: Placebo
Biological: BNT164a1
Biological: BNT164b1

First Posted Date: 2022-09-21

Last Posted Date: 2025-04-27

Lead Sponsor: BioNTech SE

Target Recruit Count: 492

Registration Number: NCT05547464

Locations: 🇲🇿
Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique
🇿🇦
Africa Health Research Institute (AHRI), Mtubatuba, South Africa
🇿🇦
The Aurum Institute Tembisa CRC Clinic 4, Tembisa, South Africa

and more 5 locations

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

Phase 2

Recruiting

Conditions: SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19

Interventions: Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 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: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

First Posted Date: 2022-09-16

Last Posted Date: 2024-05-14

Lead Sponsor: BioNTech SE

Target Recruit Count: 3692

Registration Number: NCT05543616

Locations: 🇺🇸
Kaiser Permanente, Los Angeles, California, United States
🇺🇸
Emory Children's Center, Atlanta, Georgia, United States
🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States

and more 103 locations

Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People

Phase 1

Completed

Conditions: COVID-19
SARS-CoV-2 Infection

Interventions: Biological: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg
Biological: BNT162b4 30 µg
Biological: BNT162b4 5 µg
Biological: BNT162b4 10 µg
Biological: BNT162b4 15 µg
Biological: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg

First Posted Date: 2022-09-15

Last Posted Date: 2025-01-17

Lead Sponsor: BioNTech SE

Target Recruit Count: 383

Registration Number: NCT05541861

Locations: 🇺🇸
Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States
🇺🇸
Clinical Research Consulting, LLC, Milford, Connecticut, United States
🇺🇸
Diablo Clinical Research, Inc., Walnut Creek, California, United States

and more 13 locations

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers

Phase 1

Active, not recruiting

Conditions: Tuberculosis

Interventions: Other: Placebo
Biological: BNT164a1
Biological: BNT164b1

First Posted Date: 2022-09-13

Last Posted Date: 2025-02-25

Lead Sponsor: BioNTech SE

Target Recruit Count: 120

Registration Number: NCT05537038

Locations: 🇩🇪
CRS Clinical Research Services Berlin GmbH, Berlin, Germany
🇩🇪
emovis GmbH, Berlin, Germany
🇩🇪
CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

Phase 2

Completed

Conditions: COVID-19
SARS-CoV-2 Infection

Interventions: Biological: BNT162b5 Bivalent (WT/OMI BA.2)
Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)
Biological: BNT162b2 Bivalent (WT/OMI BA.1)

First Posted Date: 2022-07-25

Last Posted Date: 2024-04-11

Lead Sponsor: BioNTech SE

Target Recruit Count: 1454

Registration Number: NCT05472038

Locations: 🇺🇸
Bayview Research Group, LLC, Valley Village, California, United States
🇺🇸
Clinical Research Professionals, Chesterfield, Missouri, United States
🇺🇸
PharmQuest Life Sciences, LLC, Greensboro, North Carolina, United States

and more 28 locations

A Clinical Trial in Healthy Volunteers and Volunteers with Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination with an Investigational Vaccine Designed to Prevent Genital Herpes Lesions

Phase 1

Recruiting

Conditions: Genital Herpes Simplex Type 2

Interventions: Biological: BNT163
Other: Placebo

First Posted Date: 2022-06-27

Last Posted Date: 2025-02-12

Lead Sponsor: BioNTech SE

Target Recruit Count: 308

Registration Number: NCT05432583

Locations: 🇺🇸
Alliance for Multispecialty Research, LLC, Tempe, Arizona, United States
🇺🇸
Great Lakes Clinical Trials - Flourish Research, Chicago, Illinois, United States
🇺🇸
Accellacare Raleigh Medical Group, Raleigh, North Carolina, United States

and more 3 locations

Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

Phase 3

Completed

Conditions: COVID-19
SARS-CoV-2 Infection

Interventions: Biological: BNT162b2
Other: Placebo
Biological: Seasonal Inactivated Influenza Vaccine

First Posted Date: 2022-04-04

Last Posted Date: 2024-06-12

Lead Sponsor: BioNTech SE

Target Recruit Count: 1134

Registration Number: NCT05310084

Locations: 🇦🇺
Barwon Health, Geelong, Victoria, Australia
🇳🇿
New Zealand Clinical Research (Auckland), Grafton, Auckland, New Zealand
🇳🇿
P3 Research - Hawke's Bay, Havelock North, Hawke's BAY, New Zealand

and more 23 locations

Safety and Preliminary Efficacy Trial of BNT142 in Patients with CLDN6-positive Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Biological: BNT142

First Posted Date: 2022-03-02

Last Posted Date: 2025-01-31

Lead Sponsor: BioNTech SE

Target Recruit Count: 330

Registration Number: NCT05262530

Locations: 🇪🇸
MD Anderson Cancer Center, Madrid, Spain
🇪🇸
START Madrid-FJD Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
🇪🇸
Hospital Universitario 12 de Octubre - Centro de Actividades Ambulatorias, Madrid, Spain

and more 21 locations

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