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BioNTech SE (BNTX)

BioNTech SE, a biotechnology firm, specializes in the creation and marketing of immune-based treatments for malignancies and various infectious diseases. A significant part of its oncology pipeline includes the FixVac cancer vaccine program, which features several candidates in different phases of clinical development: BNT111 is in Phase 2 for advanced melanoma. BNT112 has reached Phase 1/2a for prostate cancer. BNT113 is undergoing Phase 2 investigation for HPV-positive head and neck cancers. BNT114 is in Phase 1 for triple-negative breast cancer. BNT115 is also in Phase 1, targeting ovarian cancer. BNT116 is a preclinical candidate for non-small cell lung cancer. The company also pioneers personalized therapies that target neoantigens, such as Autogene cevumeran (BNT122), which is in Phase 2 for first-line melanoma and Phase 1a/1b for a range of solid tumors. Furthermore, its pipeline includes an mRNA-based intratumoral immunotherapy, SAR441000, currently in Phase 1 for solid tumors, as well as BNT141 and BNT142, also in Phase 1 for multiple solid tumors. BioNTech's portfolio extends to RiboCytokine therapies (BNT151, BNT152, and BNT153) aimed at solid tumors, and cutting-edge chimeric antigen receptor T-cell (CAR T-cell) immunotherapies like BNT211 for various solid tumors and BNT221 for other types of cancer. Immune checkpoint modulators, specifically GEN1046 and GEN1042, are also under Phase 1/2 clinical investigation for solid tumors. Beyond these, the firm is developing BNT321, an IgG1 monoclonal antibody in Phase 2 for pancreatic cancer, and BNT411, a small molecule immunomodulator candidate for solid tumors. Its broader scope encompasses preventative vaccines for illnesses like COVID-19 and Influenza, additional immunotherapies for infectious diseases, and protein replacement therapies designed for rare conditions. To advance its extensive pipeline, BioNTech has forged strategic partnerships with major pharmaceutical and biotechnology firms, including Genentech, Sanofi S.A., Genmab A/S, Pfizer Inc., Shanghai Fosun Pharmaceutical (Group) Co., Ltd., and Regeneron Pharmaceuticals, Inc. Established in 2008, BioNTech SE maintains its principal operations in Mainz, Germany.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

BioNTech SE logo

BioNTech SE

NASDAQ:BNTXHealthcare
-1.08%$88.17
AH$88.14-0.03%vs close
Mkt Cap$22.15B
Float60.2M
O/S251.2M
Vol
$ Vol
RVOL
Inst Own18.0%
SI3.8%
Earnings
Dilution
BioNTech SE logoNASDAQ:BNTX$88.17-1.08%
Upcoming Catalysts
Phase Distribution
85 lead-sponsored trials·30 active·40 completed
Phase 122
Phase 1/223
Phase 214
Phase 2/36
Phase 315
Phase 42
Not applicable3
(35 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

    BNT162b2

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    160
    Start
    Oct 2020
    Primary Completion
    Nov 2021
    Completion
    Nov 2021
    NCT04588480
  • Phase 4
    Recruiting

    A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age

    BNT162b2 Vaccine, Tdap Vaccine

    COVID-19 Vaccines

    Enrollment
    200
    Start
    Jul 2026
    Primary Completion
    Aug 2027est.
    Completion
    Aug 2027est.
    NCT07730450
  • Phase 3
    Completed

    A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

    BNT162b2, BNT162b2.B.1.351

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    1,574
    Start
    Feb 2021
    Primary Completion
    Jul 2021
    Completion
    Jul 2021
    NCT04713553
  • Phase 3
    Completed

    Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

    Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    11,837
    Start
    Mar 2021
    Primary Completion
    Oct 2023
    Completion
    Dec 2023
    NCT04816643
  • Phase 3
    Completed

    A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

    BNT162b2

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    629
    Start
    Apr 2021
    Primary Completion
    Dec 2021
    Completion
    Dec 2021
    NCT04816669
  • Phase 3
    Completed

    To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

    BNT162b2, BNT162b2 OMI

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    16,372
    Start
    Jul 2021
    Primary Completion
    May 2023
    Completion
    May 2023
    NCT04955626
  • Phase 3
    Completed

    Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

    BNT162b2, Seasonal Inactivated Influenza Vaccine

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    1,134
    Start
    Apr 2022
    Primary Completion
    Oct 2022
    Completion
    Oct 2022
    NCT05310084
  • Phase 3
    Completed

    A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

    Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

    SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2 +1

    Enrollment
    4,338
    Start
    Sep 2022
    Primary Completion
    Jul 2026
    Completion
    Jul 2026
    NCT05543616
  • Phase 3
    Completed

    A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

    Influenza and COVID-19 Combination A, Licensed influenza vaccine

    Influenza, COVID-19

    Enrollment
    8,795
    Start
    Dec 2023
    Primary Completion
    Nov 2024
    Completion
    Nov 2024
    NCT06178991
  • Phase 3
    Recruiting

    A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

    BNT323/DB-1303, Doxorubicin

    Endometrial Cancer

    Enrollment
    480
    Start
    Jun 2025
    Primary Completion
    Mar 2028est.
    Completion
    Nov 2029est.
    NCT06340568
  • Phase 3
    Recruiting

    Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

    Pumitamig, Atezolizumab

    Extensive-stage Small-cell Lung Cancer

    Enrollment
    621
    Start
    Feb 2025
    Primary Completion
    Apr 2029est.
    Completion
    Jul 2029est.
    NCT06712355
  • Phase 3
    Completed

    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 Participants Ages ≥65 Years

    BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

    COVID-19, SARS-COV-2 Infection

    Enrollment
    774
    Start
    Jul 2025
    Primary Completion
    May 2026
    Completion
    May 2026
    NCT07069309
  • Phase 3
    Recruiting

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

    Pumitamig, Nab-paclitaxel/Paclitaxel

    Breast Neoplasms

    Enrollment
    558
    Start
    Oct 2025
    Primary Completion
    Dec 2029est.
    Completion
    Sep 2030est.
    NCT07173751
  • Phase 3
    Completed

    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

    BNT162b2 (2025/2026 formulation)

    COVID-19, SARS-COV-2 Infection

    Enrollment
    344
    Start
    Oct 2025
    Primary Completion
    Jul 2026
    Completion
    Jul 2026
    NCT07222384
  • Phase 3
    Completed

    A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

    BNT162b2 Vaccine, Placebo

    COVID-19, SARS-COV-2 Infection

    Enrollment
    5,240
    Start
    Dec 2025
    Primary Completion
    Sep 2026
    Completion
    Sep 2026
    NCT07300839
  • Phase 3
    Recruiting

    A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

    BNT324, Docetaxel

    Metastatic Castration-resistant Prostate Cancer

    Enrollment
    736
    Start
    Apr 2026
    Primary Completion
    Feb 2031est.
    Completion
    Feb 2031est.
    NCT07365995
  • Phase 3
    Recruiting

    A Study of COVID-19 Vaccine(s) in Children and Adults

    BNT162b2, BNT162b2

    COVID-19 Vaccines

    Enrollment
    700
    Start
    Aug 2026
    Primary Completion
    Apr 2027est.
    Completion
    Apr 2027est.
    NCT07798648
  • Phase 2/3
    Completed

    Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

    BNT162b1, BNT162b2

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    46,969
    Start
    Apr 2020
    Primary Completion
    Feb 2023
    Completion
    Feb 2023
    NCT04368728
  • Phase 2/3
    Active, not recruiting

    A 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-L1

    BNT113, Pembrolizumab

    Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer +1

    Enrollment
    358
    Start
    Jan 2021
    Primary Completion
    Apr 2029est.
    Completion
    Apr 2029est.
    NCT04534205
  • Phase 2/3
    Completed

    To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

    BNT162b2

    SARS-CoV-2 Infection, COVID-19 +1

    Enrollment
    726
    Start
    Feb 2021
    Primary Completion
    Jul 2022
    Completion
    Jul 2022
    NCT04754594
  • Phase 2/3
    Completed

    A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

    BNT162b5 Bivalent (WT/OMI BA.2), BNT162b2 Bivalent (WT/OMI BA.1)

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    1,453
    Start
    Jul 2022
    Primary Completion
    Mar 2024
    Completion
    Mar 2024
    NCT05472038
  • Phase 2/3
    Completed

    A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

    BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1)

    SARS-CoV-2 Infection, COVID-19

    Enrollment
    1,051
    Start
    Aug 2023
    Primary Completion
    Mar 2025
    Completion
    Mar 2025
    NCT05997290
  • Phase 2/3
    Recruiting

    Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

    Pumitamig, Pembrolizumab

    Non-small Cell Lung Cancer

    Enrollment
    1,580
    Start
    Jan 2025
    Primary Completion
    Jan 2029est.
    Completion
    Dec 2031est.
    NCT06712316
  • Phase 2
    Active, not recruiting

    A 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 Cancer

    RO7198457 intravenous (IV)

    Colorectal Cancer Stage II, Colorectal Cancer Stage III

    Enrollment
    327
    Start
    Mar 2021
    Primary Completion
    Nov 2026est.
    Completion
    Nov 2026est.
    NCT04486378
  • Phase 2
    Completed

    A 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 Treatment

    BNT111, Cemiplimab

    Melanoma Stage III, Melanoma Stage IV +1

    Enrollment
    184
    Start
    May 2021
    Primary Completion
    Jan 2024
    Completion
    Nov 2025
    NCT04526899

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