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    DRUG:

    RTX-321

    i
    Other names: RTX-321, RTX-321 (HPV+), RTX‑aAPC (HPV+), RCT-aAPC
    Associations

    News

    Trials
    Company:
    Rubius Therap
    Drug class:
    CD137 agonist, Cytotoxic T lymphocyte stimulant, HPV-16 E6 protein inhibitor, IL-12 stimulant
    Related drugs:
    Associations

    News

    Trials
    2years
    RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov)
    P1, N=9, Terminated, Rubius Therapeutics | RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).
    Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
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    HLA-A*02:01 • HLA-A*02
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    RTX-321
    over2years
    RTX-321 Monotherapy in Patients With HPV 16+ Tumors (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Rubius Therapeutics | Recruiting --> Active, not recruiting | N=63 --> 9
    Enrollment closed • Enrollment change
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02:01 • HLA-A*02
    |
    RTX-321
    over3years
    [VIRTUAL] A phase 1 study of RTX-321, an engineered red blood cell as an artificial antigen-presenting cell expressing HLA-A*02 with the HPV-16 E7 peptide and 4-1BB ligand with membrane-bound IL-12 for the treatment of HPV 16-positive cancers. (ASCO 2021)
    Translational studies will investigate the activation and expansion of HPV16 E7 antigen-specific responses as well as broad innate and adaptive responses in multiple peripheral blood samples over the first 3 cycles of therapy as well as in optional paired tumor biopsies . At this time, the study is open and enrolling patients in the first dose escalation cohort (NCT04672980).
    P1 data
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    RTX-321
    over4years
    [VIRTUAL] In vivo efficacy and pharmacodynamic analysis of RTX-321, an engineered allogeneic artificial antigen presenting red cell therapeutic (AACR-II 2020)
    Together, these data confirm that RCT-aAPC can induce activation of antigen-specific CD8 T cells which can translate to tumor regression. Rubius plans to file an Investigational New Drug application for RTX-321 in HPV16+ advanced solid tumors in 2020.
    PK/PD data • Preclinical • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha)
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    RTX-321
    over4years
    An Engineered Allogeneic Artificial Antigen Presenting Red Cell Therapeutic, Rtx321, for Hpv16+ Associated Cancers Promotes Antigen-Specific T Cell Activation & Expansion (ASGCT 2020)
    These results support the potential of RTX-321 as an effective aAPC. We plan to file an Investigational New Drug application for RTX-321 for the treatment of patients with HPV 16 positive solid tumors by the end of 2020.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha) • CD34 (CD34 molecule)
    |
    RTX-321