Lund, Sweden (Press Release) – 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.

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.

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 at 12.00 a.m. CET, on 8 November, 2016.

Source: BioInvent.