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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

114

Active:48
Completed:26

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 (109 trials with phase data)• Click on a phase to view related trials

Phase 1
71 (65.1%)
Phase 2
21 (19.3%)
Not Applicable
8 (7.3%)
Phase 3
7 (6.4%)
phase_1_2
1 (0.9%)
Phase 4
1 (0.9%)

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
Not yet recruiting
Conditions
Advanced Solid Tumor
Interventions
Biological: BNT3212
First Posted Date
2025-08-29
Last Posted Date
2025-08-29
Lead Sponsor
BioNTech SE
Target Recruit Count
375
Registration Number
NCT07147348

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
Not yet recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2025-08-08
Last Posted Date
2025-08-08
Lead Sponsor
BioNTech SE
Target Recruit Count
420
Registration Number
NCT07111520

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

Not Applicable
Recruiting
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: SoC chemotherapy treatment 1
Drug: SoC chemotherapy treatment 2
First Posted Date
2025-07-23
Last Posted Date
2025-08-08
Lead Sponsor
BioNTech SE
Target Recruit Count
482
Registration Number
NCT07079631
Locations
🇺🇸

START Midwest, Grand Rapids, Michigan, United States

A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Not Applicable
Recruiting
Conditions
Advanced Solid Tumor
Interventions
First Posted Date
2025-07-17
Last Posted Date
2025-08-28
Lead Sponsor
BioNTech SE
Target Recruit Count
550
Registration Number
NCT07070232
Locations
🇺🇸

START Midwest, LLC, Grand Rapids, Michigan, United States

🇺🇸

South Texas Accelerated Research Therapeutics (START), LLC, San Antonio, Texas, United States

🇺🇸

START Mountain Region, West Valley City, Utah, United States

and more 4 locations
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News

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.

COVID-19 Vaccine Stocks Plummet on Reports of Potential Market Withdrawal

Vaccine manufacturers experienced significant stock declines following reports that the US government may remove mRNA COVID-19 vaccines from the market within months.

BioNTech's BNT113 mRNA Cancer Vaccine Advances in Phase 2 Trial for HPV+ Head and Neck Cancer

BioNTech's BNT113, an mRNA cancer vaccine targeting HPV16+ oncoproteins E6 and E7, is being evaluated in the Phase 2 AHEAD-MERIT trial combined with pembrolizumab versus pembrolizumab alone for unresectable recurrent or metastatic HPV+ head and neck squamous cell carcinoma.

HHS Halts Vaxart's $460 Million Oral COVID-19 Vaccine Trial Amid Federal mRNA Program Rollback

The Department of Health and Human Services issued a stop work order on August 5, 2025, halting Vaxart's Phase IIb trial for VXA-CoV2-3.3, an oral COVID-19 vaccine that had enrolled approximately 5,000 of its targeted 10,000 participants.

IO Biotech's Melanoma Vaccine Narrowly Misses Primary Endpoint in Phase 3 Trial Despite Promising Subgroup Results

IO Biotech's cancer vaccine Cylembio combined with Keytruda showed a 23% relative risk reduction in disease progression or death compared to Keytruda alone, but narrowly missed statistical significance with a p-value of 0.056.

GSK Secures $370 Million Settlement and Future Royalties in CureVac-BioNTech mRNA Patent Dispute

GSK will receive $370 million upfront from CureVac following a patent settlement involving BioNTech and Pfizer over mRNA vaccine technology, with $320 million paid in cash.

OncoC4's ONC-841 Shows Promise as First-in-Class Alzheimer's Disease Immunotherapy in Preclinical Studies

OncoC4 unveiled preclinical data showing ONC-841, a first-in-class anti-SIGLEC 10 monoclonal antibody, reduced amyloid plaques and improved memory in Alzheimer's disease mouse models.

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