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     172  0 Kommentare Transgene Reports Business Update and End Q1 2021 Financial Position - Seite 2

    ✓ Trial ongoing in the United Kingdom and in France

    ✓ First patient treated in Jan. 2021 – Inclusions and patient dosing progressing
    in line with forecast

    ➲ First data expected in 4Q 2021

    TG4001

    + avelumab
    Phase II

    NCT03260023

    Targets: HPV16 E6 and E7 oncoproteins

    Recurrent/metastatic anogenital HPV-positive – 1st and 2nd line

    A Phase II randomized trial comparing the efficacy of TG4001 + avelumab versus
    avelumab single-agent benefits from the extended clinical collaboration with
    Merck KGaA and Pfizer, for the supply of avelumab

    ✓ Regulatory authorizations received in the Unites States, Spain, and France

    ➲ Patient enrollment in the randomized trial expected to start in 2Q 2021

    ➲ First data from the randomized trial are expected around the end of 2022.
    This timeline is based on patient enrollment starting in 2Q 2021 and there being
    no major impact on recruitment from the Covid-19 pandemic.

    Invir.IO

    BT-001

    Phase I/IIa

     

    NCT04725331

    Payload: anti-CTLA4 antibody and GM-CSF cytokine

    Solid tumors

    ✓ Co-development with BioInvent

    ✓ Trial ongoing in France and Belgium

    ✓ First patient enrolled in February 2021 – Inclusions and patient dosing
    progressing in line with forecast

    ➲ US IND expected in 2021

    ➲ First Phase I data expected in 1H 2022

    TG6002

    Phase I/IIa

    NCT03724071

    Payload: FCU1 for the local production of a 5-FU chemotherapy

    Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

    ✓ Multicenter trial ongoing in Belgium, France and Spain

    Poster presentation at AACR 2021 on initial data of the trial, demonstrating
    the clinical proof of concept of the intravenous route of administration

    ➲ Phase I part ongoing

    TG6002

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    Transgene Reports Business Update and End Q1 2021 Financial Position - Seite 2 Regulatory News: Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces its business update for the quarter ending March 31, 2021, and …