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COMPANY

BioNTech US Inc.

HQ: Cambridge, MA source · biontech.com ↗

Clinical Phase 3

Keywords: oncology infectious disease mRNA Non-small Cell Lung Cancer COVID-19 SARS-COV-2 Infection Colorectal Cancer Stage II Colorectal Cancer Stage III COVID-19 Vaccines Locally Advanced Breast Cancer Extensive-stage Small-cell Lung Cancer HIV -1 Infection Tuberculosis Influenza Breast Neoplasms Bacterial Vaginosis Unresectable Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer Metastatic Castration-resistant Prostate Cancer Endometrial Cancer Unresectable Breast Carcinoma Metastatic Breast Cancer Monkeypox Small-cell Lung Cancer Malaria Advanced Lung Cancer Influenza,Human Advanced Solid Tumor Cancer Mpox (Monkeypox) Smallpox Orthopoxvirus Infection SARS-CoV-2 Virus Severe Acute Respiratory Syndrome Coronavirus 2 Pancreatic Ductal Adenocarcinoma Metastatic Colorectal Cancer Triple Negative Breast Cancer Metastatic Triple Negative Breast Cancers Recurrent Glioblastoma SARS-CoV-2

Location: Cambridge, MA · source · Oct 13, 2026

Profile checked Oct 10, 2026

74Trials (company is sponsor)

Timeline

  1. Trial start Phase 3: A Study of COVID-19 Vaccine(s) in Children and Adults source ↗
  2. Trial start Phase 1: A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV source ↗
  3. Trial start Phase 4: A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age source ↗
  4. Trial start III: A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer source ↗
  5. Trial start Phase 1/Phase 2: Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors source ↗
  6. Trial start Phase 2: A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa source ↗
  7. Trial start Phase 1: A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV source ↗
  8. Trial start Phase 2: A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma source ↗
  9. Trial start Phase 3: A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age source ↗
  10. Trial start Phase 2: A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer source ↗
  11. Trial start Phase 1/Phase 2: 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 source ↗
  12. Trial start Phase 3: ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer source ↗
  13. Trial start Phase 3: 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 source ↗
  14. Trial start Phase 1/Phase 2: 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 source ↗
  15. Trial start Phase 1/Phase 2: 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 source ↗
  16. Trial start Phase 1/Phase 2: 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 source ↗
  17. Trial start Phase 1/Phase 2: A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Benefici source ↗
  18. Trial start Phase 3: A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Pa source ↗
  19. Trial start Phase 3: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer source ↗
  20. Trial start Phase 1/Phase 2: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer source ↗
  21. Trial start Phase 1/Phase 2: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Co source ↗
  22. Trial start Phase 2: Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Tr source ↗
  23. Trial start Phase 1/Phase 2: A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People source ↗
  24. Trial start Phase 3: Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer source ↗
  25. Trial start Phase 1/Phase 2: Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors source ↗

Showing 25 of 50 dated events.

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 74

RecordTitlePhaseStatusStartPrimary completion
NCT07070232A 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 TumorsPhase 1/Phase 2RecruitingAug 12, 20252028-03 (estimated)
NCT04486378A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal CancerIIActive, not recruitingMar 8, 20212026-11 (estimated)
NCT07173751ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast CancerPhase 3RecruitingOct 30, 20252029-12 (estimated)
NCT06469164A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial VaginosisPhase 1CompletedJul 1, 2024Jul 31, 2025 (actual)
NCT07798648A Study of COVID-19 Vaccine(s) in Children and AdultsPhase 3RecruitingAug 31, 2026Apr 21, 2027 (estimated)
NCT06712316Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung CancerPhase 2/Phase 3RecruitingJan 7, 20252029-01 (estimated)
NCT04534205A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1Phase 2/Phase 3Active, not recruitingJan 7, 20212028-08 (estimated)
NCT07365995A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate CancerIIIRecruitingApr 22, 20262031-02 (estimated)
NCT06340568A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine CancerPhase 3RecruitingJun 10, 20252028-03 (estimated)
NCT06827236A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast CancerPhase 1/Phase 2RecruitingApr 23, 20252029-08 (estimated)
NCT06150183Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid TumorsPhase 1Active, not recruitingNov 30, 2023Aug 18, 2026 (actual)
NCT05988203A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox VaccinesPhase 1/Phase 2CompletedSep 21, 2023Aug 25, 2025 (actual)
NCT06449209Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With ChemotherapyPhase 2Active, not recruitingAug 5, 20242027-06 (estimated)
NCT06750185Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsPhase 1/Phase 2RecruitingJan 13, 20252031-04 (estimated)
NCT06712355Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung CancerPhase 3RecruitingFeb 3, 20252028-12 (estimated)
NCT07392372A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIVPhase 1RecruitingFeb 9, 20262026-11 (estimated)
NCT06069544A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against MalariaPhase 1/Phase 2CompletedNov 13, 2023May 28, 2025 (actual)
NCT07186842A 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 CA19-9Phase 1/Phase 2RecruitingNov 18, 20252030-05 (estimated)
NCT06892548A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung CancerPhase 1/Phase 2RecruitingMay 2, 20252028-09 (estimated)
NCT07698600A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIVPhase 1RecruitingAug 4, 20262028-02 (estimated)
NCT06683352A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy PeoplePhase 1/Phase 2CompletedNov 11, 2024Jul 15, 2025 (actual)
NCT07455734Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid TumorsPhase 1/Phase 2RecruitingMar 30, 20262030-10 (estimated)
NCT07379580A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in AfricaPhase 2RecruitingFeb 20, 20262027-06 (estimated)
NCT07730450A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of AgePhase 4RecruitingJul 23, 2026Aug 20, 2027 (estimated)
NCT07222384A 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-19Phase 3CompletedOct 30, 2025Jul 24, 2026 (actual)
NCT05543616A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy ChildrenPhase 3CompletedSep 23, 2022Jul 10, 2026 (actual)
NCT07111520A 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)Phase 1/Phase 2RecruitingSep 22, 20252028-11 (estimated)
NCT07255404A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic CancerPhase 2RecruitingDec 4, 20252027-12 (estimated)
NCT05142189Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung CancerPhase 1RecruitingJun 17, 20222030-02 (estimated)
NCT07079631A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal CancerPhase 1/Phase 2RecruitingJul 18, 20252030-12 (estimated)
NCT06449222Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With ChemotherapyPhase 2Active, not recruitingAug 26, 20242028-08 (estimated)
NCT07147348A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid TumorsPhase 1/Phase 2RecruitingAug 27, 20252027-11 (estimated)
NCT07069309A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 YearsPhase 3CompletedJul 8, 2025May 1, 2026 (actual)
NCT04816643Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy ChildrenPhase 3CompletedMar 24, 2021Oct 4, 2023 (actual)
NCT04813627Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant ChemotherapyNot listedCompletedJul 2, 2021Apr 23, 2025 (actual)
NCT07297212A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaPhase 2RecruitingJan 15, 20262028-01 (estimated)
NCT05997290A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy IndividualsPhase 2/Phase 3CompletedAug 10, 2023Mar 13, 2025 (actual)
NCT06841055Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line TreatmentPhase 2RecruitingMar 3, 20252028-10 (estimated)
NCT07300839A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of AgePhase 3Active, not recruitingDec 10, 2025Jul 31, 2026 (estimated)
NCT05262530Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid TumorsPhase 1/Phase 2TerminatedMar 22, 2022Dec 22, 2025 (actual)
NCT04368728Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy IndividualsPhase 2/Phase 3CompletedApr 29, 2020Feb 10, 2023 (actual)
NCT04649021Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy PopulationPhase 2CompletedDec 4, 2020Feb 7, 2021 (actual)
NCT05547464Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated VolunteersPhase 1/Phase 2Active, not recruitingJul 31, 2023Mar 12, 2026 (actual)
NCT02316457RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uIDPhase 1Completed2016-10May 13, 2020 (actual)
NCT02410733Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced MelanomaPhase 1Completed2015-03Jun 20, 2023 (actual)
NCT06821061A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy PeoplePhase 1/Phase 2CompletedFeb 10, 2025Dec 17, 2025 (actual)
NCT05541861Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy PeoplePhase 1CompletedNov 8, 2022Nov 22, 2024 (actual)
NCT04526899A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of TreatmentPhase 2CompletedMay 19, 2021Jan 25, 2024 (actual)
NCT05537038Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy VolunteersPhase 1CompletedApr 18, 2023Jun 6, 2025 (actual)
NCT06178991A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.Phase 3CompletedDec 20, 2023Nov 26, 2024 (actual)
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