LUND, Sweden--(BUSINESS WIRE)--Regulatory News:
BioInvent International (STO:BINV) announces that it has decided to terminate its current clinical Phase II study with BI-505 in multiple myeloma. The decision follows BioInvent’s review and discussion with the US Food & Drug Administration (FDA), who put BI-505 on full clinical hold in November 2016.
The terminated trial, which was performed in collaboration with Penn Medicine, targeted a specific population of multiple myeloma patients undergoing autologous stem cell transplantation with high-dose melphalan.
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 clinical programmes include BI-1206, currently in a Phase I/II for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, BI-505 for multiple myeloma, and TB-403, in cooperation with Oncurious, currently in Phase I/II for medulloblastoma. BioInvent has an exciting pre-clinical portfolio based on novel immuno-modulatory antibodies that target regulatory T cells (T-regs) and tumour associated macrophages (TAMs). BioInvent works with leading academic institutions including the University of Southampton, Cancer Research UK, and Penn Medicine. BioInvent generates revenues from global partnerships, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma and from its manufacturing facility for the production of antibodies for research through to late-stage clinical trials.
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
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 4.45 p.m. CET, on 9 December, 2016.
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