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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
    1m
    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 | N=32 --> 51
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • BNT116
    2ms
    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=320, Recruiting, BioNTech SE | N=156 --> 320
    Enrollment change • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • RET rearrangement
    |
    Tagrisso (osimertinib) • carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    10ms
    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
    |
    Libtayo (cemiplimab-rwlc) • BNT116
    11ms
    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
    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=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
    over1year
    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
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
    over2years
    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
    |
    docetaxel • BNT116
    over2years
    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
    over2years
    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
    almost3years
    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
    |
    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)
    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
    over3years
    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