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    DRUG:

    ISA101

    i
    Other names: SLP-HPV-01, HPV-SLP, ISA101b, ISA101, HPV16-SLP, human papilloma virus type 16 E6/E7 synthetic long peptide, ISA 101b, ISA 101, ISA-101, ISA-HPV, ISA-HPV-01, ISA-HPV-SLP
    Associations

    News

    Trials
    Company:
    ISA Pharma
    Drug class:
    HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, Dan Zandberg | Recruiting --> Active, not recruiting | N=50 --> 18 | Trial completion date: Jun 2027 --> Jun 2026 | Trial primary completion date: Jun 2027 --> Jun 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • ISA101
    3ms
    Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy (clinicaltrials.gov)
    P2, N=113, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> May 2024
    Trial completion • Trial completion date
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    8ms
    Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer. (ASCO 2024)
    Results from this phase 2 study of cemiplimab + ISA101b in patients with recurrent HPV16 cervical cancer show clinical benefit, especially in patients with high PD-L1 expression, and no unexpected safety signals, supporting further research.
    PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    11ms
    ProcemISA: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, ISA Pharmaceuticals | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Jun 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    12ms
    OpcemISA: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Active, not recruiting, ISA Pharmaceuticals | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    over1year
    Combination immunotherapy with synthetic long peptides and chemotherapy or PD-1 blocker for cancers caused by human papilloma virus type 16. (PubMed, Semin Immunopathol)
    In patients with late-stage recurrent or metastatic HPV16+ cancers, we have therefore combined treatment with the SLP vaccine, called ISA101b, with either standard-of-care chemotherapy or with immune checkpoint inhibition with anti-PD-1 monoclonal antibody. In this trial, the clinical overall response rate (ORR) in 22 patients was 36%, twice the ORR in the nivolumab registration trial for this category of patients, and 2/22 patients had a complete clinical response that is ongoing after 4 1/2 years. Other promising strategies for late-stage cancer recipients are the infusion of expanded tumor-infiltrating lymphocytes or the infusion of T cell receptor transduced T cells, both directed against HPV16.
    Review • Journal
    |
    IFNG (Interferon, gamma)
    |
    Opdivo (nivolumab) • ISA101
    almost2years
    OpcemISA: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Active, not recruiting, ISA Pharmaceuticals | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2022 --> Sep 2023
    Enrollment closed • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    2years
    A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Recruiting, ISA Pharmaceuticals | Trial completion date: Nov 2022 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    over2years
    A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Recruiting, ISA Pharmaceuticals | Trial primary completion date: Dec 2021 --> Jun 2022
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    over2years
    ISA101 and nivolumab for HPV-16 cancer: updated clinical efficacy and immune correlates of response. (PubMed, J Immunother Cancer)
    Efficacy of ISA101 and nivolumab remains promising in long-term follow-up. Increased infiltration by PD-1 T cells and macrophages was predictive of response. Enrichment in gene sets associated with interferon-γ response and immune infiltration strongly predicted response to therapy. A randomized trial is ongoing to test this strategy and to further explore correlates of immune response with combined nivolumab and ISA101, versus nivolumab alone.
    Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD68 (CD68 Molecule)
    |
    Opdivo (nivolumab) • ISA101
    over3years
    A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Recruiting, ISA Pharmaceuticals | Trial primary completion date: Nov 2020 --> Dec 2021
    Clinical • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101
    almost5years
    A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC (clinicaltrials.gov)
    P2, N=194, Recruiting, ISA Pharmaceuticals | Trial completion date: Feb 2022 --> Nov 2022 | Trial primary completion date: Feb 2020 --> Nov 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • ISA101