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
BioInvent will analyse the possibility to obtain release of the clinical
hold and markets will be updated when there is further information to
Notes to editors:
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.
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