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    DRUG:

    PRGN-2009

    i
    Other names: PRGN-2009, Adenoverse cancer vaccine
    Associations

    News

    Trials
    Company:
    Precigen
    Drug class:
    Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    11d
    Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=29, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2027 --> Nov 2028 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • PRGN-2009
    16d
    PRGN-2009-201: PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=46, Recruiting, Precigen, Inc | Initiation date: Aug 2024 --> Nov 2024
    Trial initiation date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • PRGN-2009
    9ms
    PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=46, Recruiting, Precigen, Inc | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • PRGN-2009
    10ms
    Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial • Combination therapy
    |
    cisplatin • docetaxel • PRGN-2009
    12ms
    PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=46, Not yet recruiting, Precigen, Inc
    New P2 trial
    |
    Keytruda (pembrolizumab) • PRGN-2009
    12ms
    20-C-0104: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=39, Active, not recruiting, National Cancer Institute (NCI) | N=20 --> 39 | Trial completion date: Oct 2023 --> Nov 2025
    Enrollment change • Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    1year
    Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=29, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • PRGN-2009
    over1year
    Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • PRGN-2009
    over1year
    20-C-0104: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Oct 2023 --> Nov 2022
    Trial primary completion date • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    over1year
    20-C-0104: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=76 --> 20
    Enrollment closed • Enrollment change • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    over3years
    HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=76, Recruiting, National Cancer Institute (NCI) | Active, not recruiting --> Recruiting | N=10 --> 76
    Clinical • Enrollment open • Enrollment change • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    over3years
    HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=10, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    over3years
    HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers (clinicaltrials.gov)
    P1/2, N=10, Suspended, National Cancer Institute (NCI) | N=76 --> 10 | Recruiting --> Suspended
    Clinical • Enrollment change • Trial suspension • Combination therapy
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PRGN-2009
    over3years
    Characterization of a recombinant gorilla-adenovirus HPV therapeutic vaccine (PRGN-2009). (PubMed, JCI Insight)
    PRGN-2009 monotherapy in the syngeneic TC-1 model also reduced tumor volumes and weights, generated high levels of HPV16 E6-specific T cells, and increased multifunctional CD8 and CD4 T cells in the tumor microenvironment. These studies provide the first evaluation of a therapeutic gorilla adenovirus HPV vaccine, PRGN-2009, showing promising preclinical anti-tumor efficacy and induction of HPV-specific T cells, and the rationale for its evaluation in clinical trials.
    Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    PRGN-2009
    over4years
    Anti-tumor efficacy and immune responses induced by a novel therapeutic HPV-specific gorilla adenovirus off-the-shelf immunotherapeutic (PRGN-2009) (IMMUNOLOGY 2020)
    Weekly PRGN-2009 administrations led to a reduction in tumor and a trending increase in CD8 and CD4 T cells in the tumor; IHC confirmed the increase of CD8 T cells into the TME. These studies provide the first evaluation of the GAd HPV off-the-shelf immunotherapeutic PRGN-2009 and its therapeutic impact against HPV-associated cancers.
    Clinical
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    PRGN-2009