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    DRUG:

    brenetafusp (IMC-F106C)

    i
    Other names: IMC-F106C, IMCF106C, IMC F106C
    Company:
    Immunocore
    Drug class:
    CD3 agonist, PRAME inhibitor
    Related drugs:
    8ms
    PRAME Epitopes are T-Cell Immunovulnerabilities in BRD4::NUTM1 Initiated NUT Carcinoma. (PubMed, bioRxiv)
    NC is one of the most aggressive solid tumors to afflict humans and is refractory to chemotherapy, T-cell checkpoint blockade, and targeted therapies. We show PRAME epitopes are promising targets for TCR-based therapeutics like brenetafusp in NC, adding to growing momentum for addressing challenging fusion malignancies with TCR therapeutics.
    Journal • IO biomarker
    |
    PRAME (Preferentially Expressed Antigen In Melanoma) • BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    brenetafusp (IMC-F106C)
    12ms
    IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
    P3, N=680, Recruiting, Immunocore Ltd | Trial primary completion date: Dec 2026 --> Oct 2027
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    BRAF mutation • BRAF V600 • HLA-A*02
    |
    Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
    1year
    IMC-F106C-101: Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=727, Recruiting, Immunocore Ltd | Trial primary completion date: Jun 2026 --> Feb 2026
    Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Kimmtrak (tebentafusp-tebn) • brenetafusp (IMC-F106C)
    over1year
    Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=727, Recruiting, Immunocore Ltd | N=170 --> 727 | Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Feb 2024 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    HLA-A*02
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Kimmtrak (tebentafusp-tebn) • brenetafusp (IMC-F106C)
    almost2years
    IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
    P3, N=680, Recruiting, Immunocore Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    BRAF mutation • BRAF V600 • HLA-A*02
    |
    Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
    2years
    IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
    P3, N=680, Not yet recruiting, Immunocore Ltd
    New P3 trial • Metastases
    |
    BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD163 (CD163 Molecule)
    |
    BRAF mutation • BRAF V600 • HLA-A*02
    |
    Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
    over3years
    Results from phase I dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors (ESMO 2022)
    ImmTAC bispecifics redirect polyclonal T cells to target intra/extracellular cancer proteins, as validated by tebentafusp (tebe; gp100×CD3 ImmTAC) with an overall survival benefit in metastatic uveal melanoma (mUM). Conclusions IMC-F106C, the first PRAME×CD3 ImmTAC, is well tolerated and demonstrated durable RECIST partial responses and ctDNA response in PRAME+ pts across multiple tumor types. Dose escalation and multiple expansions are ongoing.
    P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    HLA-A*02
    |
    Kimmtrak (tebentafusp-tebn) • brenetafusp (IMC-F106C)
    over3years
    Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=170, Recruiting, Immunocore Ltd | Trial completion date: Feb 2024 --> Feb 2026 | Trial primary completion date: Feb 2022 --> Feb 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    HLA-A*02
    |
    brenetafusp (IMC-F106C)
    over5years
    [VIRTUAL] IMC-F106C, a novel and potent immunotherapy approach to treat PRAME expressing solid and hematologic tumors (AACR-II 2020)
    These data indicate that PRAME is expressed in a number of solid tumors, and is highly prevalent in lung tumours, irrespective of EGFR status, as well as female-oriented cancers. In conjunction, IMC-F106C efficiently redirects T cell activity against tumor cell lines that express PRAME across a range of tumor indications. Taken together, IMC-F106C could prove to be a highly effective immunotherapy option for HLA*02:01 positive patients with PRAME positive tumors.
    IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • IFNG (Interferon, gamma) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    PRAME expression
    |
    brenetafusp (IMC-F106C)