Clinical Trials

Date: 2013-04-04

Type of information: Results

phase: 1

Announcement: results

Company: BioInvent (Sweden)

Product: BI-505

Action mechanism:

• monoclonal antibody. 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 exerts its antimyeloma activity by inducing programmed 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 tumor cells more efficiently than existing drugs. BI-505 has received orphan drug designation in both Europe and the US for the indication multiple myeloma.

Disease: multiple myeloma

Therapeutic area: Cancer - Oncology

Country: USA, Belgium, Denmark, Sweden

Trial details:

• 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. (NCT01025206)

Latest news:

• • On April 4, 2013, BioInvent International has announced that the previously communicated positive results from a phase I trial of BI-505 are presented at The International Myeloma Workshop in Kyoto, Japan. The first results from the phase I study of BI-505 in patients in advanced stages of the malignant disease multiple myeloma were reported earlier this year (see below). The preliminary analysis showed that BI-505 has an advantageous safety profile. In dose groups where extended therapy was offered, 24% of these severely ill patients demonstrated stable disease for at least two months, indicating effect of BI-505. At the same meeting, new preclinical data is also presented showing significantly enhanced anti-myeloma activity when the approved drugs Velcade® or Revlimid® is combined with BI-505 compared to single agent treatment. Combined treatment was evaluated in two different experimental models and the drugs were given in a similar way as to patients with myeloma. In one of the models enhanced survival was observed following combination therapy with BI-505, compared to single agent treatment with the approved drugs. In the second model, complete remission was observed in the majority of animals when combining BI-505 with Revlimid® or Velcade®. BioInvent will now continue the studies on the product with a new smaller trial in patients with asymptomatic multiple myeloma.
• • On January 24, 2013,  BioInvent International has announced the first results from the BI-505 phase I study in patients with multiple myeloma. 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. 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 clinical trial which has already been approved by the health authorities.

Is general: Yes