On January 24, 2013 BioInvent reported the first results from the BI-505 phase I study in patients with multiple myeloma (Press release BioInvent, JAN 24, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=736831 [SID:1234500561]). The study has reached a final stage and the preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended therapy was available, 24 % of the patients had stable disease for at least two months, indicating effect of BI-505. The final conclusions of the study will be available at a later time-point. The optimal dose has been defined according to the study protocol and will be used in the next clinical trial which is approved by the health authorities.
BI-505 is a human antibody selected from the n-CoDeR-library and fully owned by BioInvent. It is directed against the ICAM-1 adhesion protein, which is highly expressed on multiple myeloma cells. BI-505 has demonstrated significant anti-tumor activity in several relevant models of multiple myeloma.
Thirty-five patients with relapsed or refractory disease after at least two previous regimens with other drugs are included in the phase I, dose escalation study. The primary objective is to determine the safety and tolerability of BI-505 in patients with advanced disease. Pharmacokinetics and pharmacodynamic variables including relevant biomarkers for tumor response are also being evaluated in order to determine the optimal dose for further clinical development. The study is being conducted at seven sites in the US and Europe.
Groups of patients are treated with increasing doses of BI-505 (0,0004 – 20 mg/kg; eleven dose levels) every second week over a four-week period, with a possibility of extended therapy every two weeks until disease progression for patients at dose level six and onwards.
The preliminary assessment demonstrates that BI-505 has a favorable safety profile with a low number of reported adverse events. Temporary infusion-related reactions were observed when the first dose was given which is commonly seen. Despite advanced disease, 7 of the 29 patients on extended therapy (at dose level six and onwards) had stable disease for at least two months. A dosing regimen of 10 mg/kg every second week resulted in complete saturation of the ICAM-1 epitopes on the patient´s bone marrow myeloma cells. The 10 mg/kg dose will thus be used in the next clinical trial which has already been approved by the health authorities.

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