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    DRUG:

    HB-201

    i
    Other names: HB-201
    Associations

    News

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

    News

    Trials
    4ms
    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
    7ms
    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
    7ms
    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
    11ms
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=10, Terminated, Hookipa Biotech GmbH | N=27 --> 10 | Recruiting --> Terminated; Sponsor decision.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    HB-201
    12ms
    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
    1year
    Characterization of tumor specific CD8+ T cell responses in patients with recurrent/metastatic HPV16-positive head and neck cancer receiving HB-200 monotherapy as second or later line treatment in a phase 1 study (SITC 2023)
    HB-200 is comprised of an alternating sequence of two replicating attenuated arenavirus vectors derived from LCMV (HB-201) and Pichinde virus (HB-202), respectively, expressing the same non-oncogenic HPV16 E7E6 fusion protein. Conclusions HB-200 monotherapy induces promising HPV16+ tumor-specific T cell responses and tumor infiltration in heavily pre-treated patients. This immune response coupled with clinical benefit in monotherapy suggests that HB-200 may enhance and strengthen current immunotherapy approaches by targeting specific tumor antigens.
    Clinical • P1 data • Metastases
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    eseba-vec (HB-200) • HB-201
    over1year
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=27, Recruiting, Hookipa Biotech GmbH | Trial completion date: Aug 2023 --> Jun 2025 | Trial primary completion date: Aug 2023 --> Jun 2025
    Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    HB-201
    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 primary completion date: Jun 2023 --> Mar 2024
    Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
    over1year
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=27, Recruiting, Hookipa Biotech GmbH | Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Feb 2023 --> Aug 2023
    Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    HB-201
    2years
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=27, Recruiting, Hookipa Biotech GmbH | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    HB-201
    over2years
    HB-201 and HB-202, an arenavirus-based immunotherapy, induces tumor T cell infiltration in patients with HNSCC and other HPV16+ tumors (AACR 2022)
    In this updated dataset, we show that HB-201 and HB-202/HB-201, rapidly induce unprecedented E6/E7 specific T cell levels in circulation following a single dose. Furthermore, these data are seen in conjunction with a pronounced increase of post-treatment CD8+ T cells in tumor, suggesting E6/E7 specific T cell infiltration. Our arenavirus vectors expressing the E7E6 fusion antigen demonstrate an attractive and safe therapy for patients with treatment refractory HPV16+ cancers.
    Clinical
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    eseba-vec (HB-200) • HB-201
    3years
    Development and Characterization of a Novel Non-Lytic Cancer Immunotherapy Using a Recombinant Arenavirus Vector Platform. (PubMed, Front Oncol)
    This response can be further enhanced by alternating injections of HB-202 and HB-201, which has resulted in frequencies of circulating HPV16 E7/E6-specific CD8 T cells of up to 40% of the total CD8 T cell compartment in peripheral blood in analyses to date. Treatment with intravenous administration also resulted in a disease control rate of 73% among 11 evaluable patients with head and neck cancer dosed every three weeks, including 2 patients with a partial response.
    Review • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    eseba-vec (HB-200) • HB-201
    over3years
    [VIRTUAL] Preliminary immunogenicity analysis of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with advanced HPV16+ cancers (CIMT 2021)
    These preliminary data provide the first demonstration of arenavirus vectors ability to induce HPV16-specific T cells in cancer patients. This is achieved following a single injection of HB-201 or HB-202. Arenavirus vectors expressing E7E6 may constitute a new potential therapy for patients with treatment refractory HPV16+ cancers.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    eseba-vec (HB-200) • HB-201
    almost4years
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=27, Recruiting, Hookipa Biotech GmbH | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    HB-201
    4years
    A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, Hookipa Biotech
    Clinical • New P1 trial • Tumor Mutational Burden • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    HB-201