08 May 2013

BioInvent International AB : BI-505 human antibody to ICAM-1

BI-505

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Product description
BI-505 is a fully human antibody derived from BioInvent's proprietary n-CoDeR® library. The antibody binds to the adhesion protein ICAM-1 (CD54), which is overexpressed in several tumours but not widely expressed in normal tissue. BI-505 is being developed to treat multiple myelomas that express ICAM-1.
Product rationale
BI-505 was identified in a screen to find antibodies that can cause cell death (apoptosis). Antibodies with this property could be used to kill cancer cells to which they bind.
Prior to BioInvent's screen and preclinical studies, the ability of anti-ICAM-1 to lead to apoptosis had not been recognised. Owing to its novel mode of action, BI-505 could be given to patients that do not respond to current treatments.
Clinical status
A dose-escalation phase I study in patients with relapsed or refractory multiple myeloma is on-going. The study explores safety, pharmacokinetics and pharmacodynamics, such as relevant biomarkers for tumour response, with the aim of defining the optimal dose of the antibody for future clinical development. Patients are treated with intravenous doses of BI-505 every second week for a 28-day period with the possibility of extending the treatment until the condition deteriorates.
BI-505 has been granted orphan drug designation for the treatment of multiple myeloma by both the FDA and the European Agency for the Evaluation of Medicines (EMEA).
Development and commercialisation strategy
We are currently developing BI-505 in house at BioInvent.