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    DRUG:

    AVB-001

    i
    Other names: AVB-001, hIL-2 IP, AVB-001 IP
    Company:
    Avenge Bio, Rice University
    Drug class:
    IL-2 stimulant
    Related drugs:
    9d
    First-In-Human Trial of Encapsulated Cell-Based Protein Producers for Localized IL-2 in Patients with High-Grade Serous Ovarian Carcinoma. (PubMed, medRxiv)
    Dose-dependent CTLA-4 receptor upregulation was observed on CD8+ and CD4+ T cells, whereas PD-1 and TIM-3, remained unchanged. In patients with HGSOC, AVB-001 is safe and effectively activates cytotoxic T cells, supporting further investigation of this locoregional immunotherapy.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • First-in-human
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    AVB-001
    over1year
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=14, Terminated, Avenge Bio, Inc | Trial completion date: Aug 2026 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2026 --> Apr 2024; Sponsor Decision to close study
    Trial completion date • Trial termination • Trial primary completion date
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001
    over1year
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=14, Active, not recruiting, Avenge Bio, Inc | Recruiting --> Active, not recruiting | N=44 --> 14
    Enrollment closed • Enrollment change
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001
    over2years
    A phase 1/2 open-label, multicenter, dose escalation and expansion study of AVB-001, an intraperitoneally administered, cell-generated, human IL-2 immunotherapy in patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube. (ASCO 2023)
    Recruitment in dose level 1 cohort continues. Clinical trial information: NCT05538624.
    Clinical • P1/2 data
    |
    IL2 (Interleukin 2)
    |
    AVB-001
    over2years
    A phase 1/2 open-label, multicenter, dose escalation and expansion study of AVB-001, an intraperitoneally administered, cell-generated, human IL-2 immunotherapy in patients with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube (AACR 2023)
    The first patient was dosed in December 2022. Recruitment in dose level 1 cohort continues.
    Clinical • P1/2 data
    |
    IL2 (Interleukin 2)
    |
    AVB-001
    3years
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=44, Recruiting, Avenge Bio, Inc | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001
    3years
    Favorable preclinical efficacy and safety profile of AVB-001 a novel IL-2 cell-based immunotherapy that eradicates ovarian cancer in mouse tumor models and supports first in human clinical development (SITC 2022)
    Background Aldesleukin, recombinant human IL-2 has been approved by the FDA for the treatment of melanoma and renal cancer. Avenge Bio aims to pursue a Phase 1 First in Human study of AVB-001 in ovarian cancer patients. The LOCOcyte TM platform enables delivery of a diverse set of cytokines alone or in combination which is presently being explored.
    P1 data • Preclinical • IO biomarker
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • AVB-001
    3years
    A Study of Intraperitoneally Administered AVB-001 in Patients With Serous Adenocarcinoma of the Ovary (clinicaltrials.gov)
    P1/2, N=44, Not yet recruiting, Avenge Bio, Inc
    New P1/2 trial
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AVB-001