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    DRUG:

    eseba-vec (HB-200)

    i
    Other names: HB-200, HB200, HB-202/HB-201, alternating 2-vector HB-202/HB-201, HB-202/HB-201 alternating
    Company:
    Hookipa Pharma
    Drug class:
    HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor
    Related drugs:
    3ms
    H-200-001: A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov)
    P1/2, N=198, Completed, Hookipa Biotech GmbH | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Jan 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    9ms
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Phase classification: P2 --> P1
    Phase classification
    |
    eseba-vec (HB-200) • HB-201
    9ms
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P2, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open
    |
    eseba-vec (HB-200) • HB-201
    11ms
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P2, N=3, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=51 --> 3
    Enrollment closed • Enrollment change
    |
    eseba-vec (HB-200) • HB-201
    12ms
    H-200-004: A Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer (clinicaltrials.gov)
    P2/3, N=0, Withdrawn, Hookipa Biotech GmbH | N=450 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    1year
    H-200-001: A Phase 1/2 Study in Patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov)
    P1/2, N=200, Active, not recruiting, Hookipa Biotech GmbH | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    over1year
    A Phase 2/3 Study of HB-202/HB-201 With Pembrolizumab in Patients With HPV16+ Recurrent/Metastatic Oropharyngeal Cancer (clinicaltrials.gov)
    P2/3, N=450, Not yet recruiting, Hookipa Biotech GmbH
    New P2/3 trial • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    over1year
    Phase II multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of HB-200 in patients with detectable TTMV-HPV DNA after definitive treatment for HPV16 + HNSCC (ESMO 2024)
    The primary objective is to assess the disease-free survival (DFS) for pts enrolled in the study receiving either HB-200 or placebo. The secondary objectives include overall survival, and safety.
    P2 data • Clinical
    |
    NavDx®
    |
    eseba-vec (HB-200)
    over1year
    A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Hookipa Biotech GmbH | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Mar 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    over1year
    Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer (Businesswire)
    "Naveris, Inc...announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The study will be led by Memorial Sloan Kettering Cancer Center (MSKCC), a top cancer treatment and research institution. The primary objective of this multicenter randomized study is to evaluate the efficacy of HB-200, a novel intervention, for patients with HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse, defined as the presence of circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA without clinical or radiographic evidence of recurrence following definitive treatment."
    Trial status
    |
    NavDx®
    |
    eseba-vec (HB-200)
    over1year
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P2, N=51, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    eseba-vec (HB-200) • HB-201
    almost2years
    A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Hookipa Biotech GmbH
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201