Lund, Sweden (Press Release) – 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.

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 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.

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.

Source: BioInvent.