BioInvent Reports Clinical Hold on BI-505 Phase II Study

- November 8th, 2016

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.
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