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BioNTech SE (BNTX)
NASDAQ:BNTX
Nivolumab, Folfox, Pumitamig, Capox
Untreated Advanced Or Metastatic Gastric, Gastroesophageal Junction, Or Esophageal Adenocarcinoma
Phase II/III
Not Yet Recruiting
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Oct 23, 2025
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Bevacizumab, Folfiri, Folfox, Pumitamig, Capox
Untreated, Unresectable, Or Metastatic Colorectal Cancer
Phase II/III
Not Yet Recruiting
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
Oct 23, 2025
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Bnt329, Ca19-9-Targeting Monoclonal Antibody
Advanced Solid Cancers
Phase I/II
Not Yet Recruiting
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
Sep 16, 2025
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Gemcitabine, Carboplatin, Eribulin, Pumitamig, Nab-Paclitaxel/Paclitaxel
Breast Neoplasms
Phase III
Not Yet Recruiting
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Sep 08, 2025
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Bnt327, Bnt3212
Advanced Solid Tumor
Phase I/II
Recruiting
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
Aug 08, 2025
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Pembrolizumab, Soc, Bnt327, Bnt326
Non-small Cell Lung Cancer
Phase I/II
Recruiting
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)
Aug 01, 2025
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Pm8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2
Crc (Colorectal Cancer)
Phase II
Not Yet Recruiting
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Jul 30, 2025
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Bevacizumab, Bnt327, Bnt314, Soc Chemotherapy Treatment 1, Soc Chemotherapy Treatment 2
Metastatic Colorectal Cancer
Phase I/II
Recruiting
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
Jul 09, 2025
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Bnt162b2 (Omi Lp.8.1)
Covid-19, Sars-Cov-2 Infection
Phase III
Recruiting
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19
Jul 07, 2025
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Paroxetine, Itraconazole, Bnt327, Bnt326
Advanced Solid Tumor
Phase I/II
Recruiting
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
Jul 03, 2025
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BioNTech SE (BNTX) have in its pipeline
BNTX is currently developing the following drugs: Nivolumab, Folfox, Pumitamig, Capox, Bevacizumab, Folfiri, Folfox, Pumitamig, Capox, Bnt329, Ca19-9-Targeting Monoclonal Antibody. These drug candidates are in various stages of clinical development as the company works toward FDA approval.