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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.

Clinical Trials

116

Active:50
Completed:27

Trial Phases

5 Phases

Phase 1:71
Phase 2:21
Phase 3:7
+2 more phases

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (111 trials with phase data)• Click on a phase to view related trials

Phase 1
71 (64.0%)
Phase 2
21 (18.9%)
Not Applicable
10 (9.0%)
Phase 3
7 (6.3%)
phase_1_2
1 (0.9%)
Phase 4
1 (0.9%)

A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19

Not Applicable
Not yet recruiting
Conditions
COVID-19
SARS-COV-2 Infection
Interventions
Biological: BNT162b2 (2025/2026 formulation)
First Posted Date
2025-10-29
Last Posted Date
2025-10-29
Lead Sponsor
BioNTech SE
Target Recruit Count
330
Registration Number
NCT07222384
Locations
🇺🇸

C & R Research USA, Homestead, Florida, United States

🇺🇸

Florida Pharmaceutical Research and Associates, Miami, Florida, United States

🇺🇸

J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City, Utah, United States

and more 1 locations

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

Not Applicable
Not yet recruiting
Conditions
Advanced Solid Cancers
Interventions
Drug: BNT329
Drug: CA19-9-targeting monoclonal antibody
First Posted Date
2025-09-22
Last Posted Date
2025-09-22
Lead Sponsor
BioNTech SE
Target Recruit Count
245
Registration Number
NCT07186842

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

Not Applicable
Not yet recruiting
Conditions
Breast Neoplasms
Interventions
Drug: Pumitamig
Drug: Nab-paclitaxel/Paclitaxel
Drug: Matching placebo
First Posted Date
2025-09-15
Last Posted Date
2025-09-15
Lead Sponsor
BioNTech SE
Target Recruit Count
558
Registration Number
NCT07173751

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

Not Applicable
Recruiting
Conditions
Advanced Solid Tumor
Interventions
Biological: BNT3212
First Posted Date
2025-08-29
Last Posted Date
2025-10-01
Lead Sponsor
BioNTech SE
Target Recruit Count
375
Registration Number
NCT07147348
Locations
🇦🇺

Scientia Clinical Research Limited, Randwick, Australia

🇨🇳

Shanghai East Hospital, Shanghai, China

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

Not Applicable
Recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2025-08-08
Last Posted Date
2025-10-22
Lead Sponsor
BioNTech SE
Target Recruit Count
420
Registration Number
NCT07111520
Locations
🇺🇸

NEXT Virginia, Fairfax, Virginia, United States

🇲🇩

Institute of Oncology, ARENSIA Exploratory Medicine, Chisinau, Moldova

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News

mRNA COVID-19 Vaccines Show Promise in Enhancing Cancer Immunotherapy Survival Rates

A new study reveals that mRNA COVID-19 vaccines from Pfizer/BioNTech and Moderna nearly double survival rates for lung cancer patients receiving immunotherapies.

Activist Investor Shah Capital Calls for Novavax Sale Amid COVID Vaccine Market Share Struggles

Shah Capital, Novavax's second-largest shareholder with a 7.2% stake, has urged the company's board to pursue a sale, citing three consecutive years of poor COVID-19 vaccine performance.

EIB and European Commission Partner with BioNTech for Africa's First mRNA Vaccine Manufacturing Facility in Rwanda

The European Investment Bank and European Commission are providing up to €95 million in blended financing to support BioNTech's construction of Africa's first commercial mRNA vaccine manufacturing facility in Kigali, Rwanda.

COVID-19 Boosters Reduce Hospitalizations and Deaths by Up to 64% in Large Veterans Study

A large study of nearly 300,000 U.S. military veterans found that 2024-2025 COVID-19 mRNA boosters reduced emergency department visits by 29%, hospitalizations by 39%, and deaths by 64% compared to unvaccinated individuals.

Moderna Settles Patent Dispute with Alnylam Over COVID-19 Vaccine Technology

Moderna has settled patent infringement lawsuits filed by Alnylam Pharmaceuticals over alleged misuse of lipid nanoparticle technology in COVID-19 vaccines.

OncoC4 and BioNTech Advance Pivotal Phase 3 Trial of Next-Generation CTLA-4 Antibody Gotistobart in Squamous NSCLC

OncoC4 will present the pivotal Stage II design of PRESERVE-003, a Phase 3 trial evaluating gotistobart versus docetaxel in squamous non-small cell lung cancer patients who progressed on chemotherapy and immune checkpoint therapies.

BioNTech-Bristol Myers Bispecific Antibody Achieves 76.3% Response Rate in Small Cell Lung Cancer Phase II Trial

BioNTech and Bristol Myers Squibb's investigational bispecific antibody pumitamig (BNT327) demonstrated a 76.3% confirmed objective response rate in a Phase II trial for extensive-stage small cell lung cancer.

BioNTech and Bristol Myers Squibb Report Promising Phase 2 Results for Pumitamig in Extensive-Stage Small Cell Lung Cancer

BioNTech and Bristol Myers Squibb presented interim Phase 2 data showing pumitamig plus chemotherapy achieved a 76.3% confirmed objective response rate and 100% disease control rate in extensive-stage small cell lung cancer patients.

Ryvu Therapeutics Partners with BioNTech to Accelerate Cancer Immunotherapy Trials in Poland

Ryvu Therapeutics has entered a strategic agreement with BioNTech to support clinical trial site activation and patient recruitment for multiple investigational cancer immunotherapies in Poland.

FDA Approves Pfizer-BioNTech LP.8.1-Adapted COVID-19 Vaccine for High-Risk Populations

The FDA approved Pfizer-BioNTech's LP.8.1-adapted monovalent COVID-19 vaccine on August 27 for adults 65 and older and individuals aged 5-64 with high-risk conditions.

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