BioInvent International AB has received clearance from the US Food & Drug Administration (FDA) to initiate a phase-I open dose-escalation study with its therapeutic cancer antibody BI-505 in patients with advanced Multiple Myeloma.

The phase-I study will investigate safety, pharmacokinetics, pharmacodynamics, and will aim to define the optimal biological dose of the antibody for phase 2 drug development. BioInvent will recruit approximately 40 patients with advanced Multiple Myeloma across three centres (possibly extending to four) in the US as part of the study.

BI-505 is a fully human antibody derived from BioInvent's proprietary n-CoDeR library and targets the adhesion molecular ICAM-1 leading to cell death. ICAM-1 is highly expressed in several tumours but is not widely expressed in normal tissue. Preclinical results have demonstrated that the compound is more efficacious to fight tumours than existing drugs. BI-505 has been granted orphan drug designation in the US and Europe for the indication of Multiple Myeloma.

Svein Mathisen, CEO of BioInvent, commented, "We are delighted that the FDA accepted our first IND, an important step in the development of the company as we further increase our presence in the US. BI-505 is our fourth product in clinical development. We believe that it has application in multiple myeloma patients resistant to other therapies, as in many cases expression of ICAM-1 in tumour cells is known to be up-regulated. This, together with strong pre-clinical results compared to the current marketed drug for the indication, suggests that BI-505 could address major unmet medical need, both in multiple myeloma and potentially other indications"

The drug candidate BI-505 is a fully human antibody that targets the adhesion protein ICAM-1 (also called CD54). In tumour cells the expression of ICAM-1 is elevated, making it an attractive target for a therapeutic antibody.