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    DRUG:

    BNT116

    i
    Other names: BNT116, BNT-116, FixVac Lung, BNT 116
    Associations

    News

    Trials
    Company:
    BioNTech
    Drug class:
    Immunostimulant, CLDN6 inhibitor, MAGE-A4 inhibitor, PRAME inhibitor, MAGE-A3 inhibitor, Kita-Kyushu lung cancer antigen-1 inhibitor, MAGE-C1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting | N=100 --> 51 | Trial completion date: Jun 2027 --> May 2028 | Trial primary completion date: Mar 2027 --> Jan 2028
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    VENTANA PD-L1 (SP263) Assay
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    Libtayo (cemiplimab-rwlc) • BNT116
    5ms
    Shared epitopes create safety and efficacy concerns in several cancer vaccines. (PubMed, J Immunother Cancer)
    Altogether, our analysis indicates a suboptimal design of several cancer vaccines currently in clinical development: ATP128, BNT111, BNT112, BNT116, INO-5401. We recommend that next-generation cancer vaccines should integrate rigorous epitope filtering strategies to eliminate shared sequences in TAAs.
    Journal
    |
    CLDN6 (Claudin 6) • KLK2 (Kallikrein-related peptidase 2) • ASCL2 (Achaete-Scute Family BHLH Transcription Factor 2)
    |
    BNT111 • INO-5401 • BNT116
    7ms
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=220, Recruiting, BioNTech SE | N=160 --> 220 | Trial completion date: Nov 2028 --> Nov 2031 | Trial primary completion date: Apr 2027 --> Feb 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    1year
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=160, Recruiting, BioNTech SE | Trial completion date: Aug 2027 --> Nov 2028 | Trial primary completion date: Jan 2026 --> Apr 2027
    Trial completion date • Trial primary completion date • Metastases
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    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
    almost2years
    Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the fixed antigen mRNA vaccine BNT116 + docetaxel in patients with advanced non-small cell lung cancer (AACR 2024)
    BNT116 + DTX shows encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Updated safety and clinical activity data will be presented along with additional biomarker data.
    P1 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CLDN6 (Claudin 6) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    AVENIO ctDNA Surveillance Kit
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    docetaxel • BNT116
    almost2years
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=130, Recruiting, BioNTech SE
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
    2years
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=130, Recruiting, BioNTech SE | N=80 --> 130 | Trial primary completion date: May 2025 --> Jan 2026
    Enrollment change • Trial primary completion date • Metastases
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
    over2years
    A phase II study of cemiplimab plus BNT116 versus cemiplimab alone in first-line treatment of patients with advanced non-small cell lung cancer with PD-L1 expression ≥50% (ESMO 2023)
    Enrollment of up to 100 patients is planned. Enrolment is ongoing.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression
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    Libtayo (cemiplimab-rwlc) • BNT116
    over2years
    Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P2
    Combination therapy • Phase classification • Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Libtayo (cemiplimab-rwlc) • BNT116
    almost3years
    Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
    P1/2; Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Jun 2027 --> Mar 2027
    Combination therapy • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Libtayo (cemiplimab-rwlc) • BNT116
    3years
    LuCa-MERIT-1: First-in-human open label dose confirmation trial evaluating safety, tolerability, and efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer (SITC 2022)
    "BNT116 alone or in combination with either docetaxel or the PD-1 inhibitor cemiplimab (Libtayo ® ) may have synergistic anti-tumor effects, thus potentially addressing the unmet medical need of these cancer patients. The first patient was dosed in JUL 2022, with enrolment expected for approximately 12 months. The study was approved by IRB/IEC, approval numbers: 2022-03/1691 (Turkey), OGYÉI/6962-9/2022 (Hungary), and US and Spain (approval numbers for the later were not provided)."
    P1 data • Clinical
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    Libtayo (cemiplimab-rwlc) • BNT116
    3years
    Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
    P1/2; N=107; Not yet recruiting; Sponsor:Regeneron Pharmaceuticals
    Combination therapy • New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Libtayo (cemiplimab-rwlc) • BNT116