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    BioInvent Reports Clinical Hold on BI-505 Phase II Study

    Chelsea Pratt
    Nov. 08, 2016 04:46AM PST
    Biotech Investing

    BioInvent International has received verbal notice from the U.S. Food and Drug Administration that a full clinical hold has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.

    BioInvent International (STO:BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma. BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.
    The clinical study is being conducted by BioInvent in collaboration with
    investigators at the University of Pennsylvania in the United States and
    aims to document the ability of BI-505 to deepen therapeutic response
    and thereby prevent or delay relapse of multiple myeloma in patients
    undergoing autologous stem cell transplantation (ASCT) with high-dose
    melphalan.
    BioInvent will analyse the possibility to obtain release of the clinical
    hold and markets will be updated when there is further information to
    report.
    Notes to editors:
    About BioInvent
    BioInvent International AB (OMXS: BINV) is focused on developing a
    first-in-class and best-in-class pipeline of antibody immunotherapeutics
    against cancer. The company’s two lead clinical programmes are BI-505,
    in Phase II development for multiple myeloma, and BI-1206, in Phase I/II
    for non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. BioInvent
    also has its own manufacturing facility for the production of antibodies
    for research through to late-stage clinical trials. The Company has
    research collaborations with leading academic institutions including
    Penn Medicine, Cancer Research UK, and the University of Southampton.
    BioInvent generates revenues from its eight global partnerships,
    including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma.
    BioInvent International AB (publ)
    Co. reg. No. 556537-7263
    Visiting address: Sölvegatan 41
    Mailing address: 223 70 LUND
    Phone: +46 (0)46 286 85 50
    info@bioinvent.com
    www.bioinvent.com
    The press release contains statements about the future, consisting of
    subjective assumptions and forecasts for future scenarios. Predictions
    for the future only apply as the date they are made and are, by their
    very nature, in the same way as research and development work in the
    biotech segment, associated with risk and uncertainty. With this in
    mind, the actual outcome may deviate significantly from the scenarios
    described in this press release. This information is information that
    BioInvent International AB is obliged to make public pursuant to the EU
    Market Abuse Regulation. The information was submitted for publication,
    through the agency of the contact person set out above, at 12.00 a.m.
    CET, on 8 November, 2016.
    This information was brought to you by Cision https://news.cision.com

    clinical trialsclinical holdfood and drug administrationcancer research
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