MedPath

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

115

Active:47
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 (110 trials with phase data)• Click on a phase to view related trials

Phase 1
71 (64.5%)
Phase 2
21 (19.1%)
Not Applicable
9 (8.2%)
Phase 3
7 (6.4%)
phase_1_2
1 (0.9%)
Phase 4
1 (0.9%)

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
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

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News

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.

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.

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