First patient dosed in BI-505 Phase II trial
The first patient has been treated in a Phase II study of BioInvent's candidate, BI-505, developed for the treatment of multiple myeloma (MM). The study is conducted in patients with asymptomatic myeloma. The current study involves up to ten patients and evaluates disease activity following treatment with BI-505. Secondary objectives include safety, pharmacokinetics and assessment of biomarkers.
BI-505 is a human antibody that specifically binds to the ICAM-1 adhesion protein. BI-505 exerts its antimyeloma activity by inducing cell death in myeloma cells and by engaging patient's immune cells to attack myeloma cells. In several animal models, BI-505 has been shown to kill tumour cells more efficiently than existing drugs. Preclinical data also demonstrate significantly enhanced antimyeloma activity when the approved drugs Velcade or Revlimid is combined with BI-505 compared with single agent treatment. The first results from the Phase I study of BI-505 in patients in advanced stages of the MM were reported earlier in 2013. The candidate drug was well tolerated and indicated therapeutic effect; seven of a total of 29 patients with advanced MM demonstrated stable disease for at least two months.
BI-505 has received orphan drug designation in both Europe and the US for the MM indication.