Date: 2013-04-16
Type of
information: Publication of results in a medical journal
phase: preclinical
Announcement: publication of results in Cancer Cell
Company: BioInvent (Sweden)
Product: BI-505
Action
mechanism:
- monoclonal antibody. BI-505 is a fully human, monoclonal antibody developed from BioInvent’s proprietary screening platform FIRST™, a function first approach to antibody drug discovery, which in its turn builds on BioInvent’s extensive n-CoDeR® library. BI-505 binds to the cell-surface protein ICAM-1 (Inter-Cellular Adhesion Molecule-1), which has been shown to be overexpressed in multiple myeloma cell lines and primary patient myeloma cells. BioInvent has shown in animal models for multiple myeloma that BI-505 kills tumor cells through induction of both programmed cell death and Fc gamma receptor dependent anti-tumour immunity. BI-505 is currently being investigated in a phase I clinical trial involving approximately 35 patients at clinical centres both in the US and EU.
Disease:
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On April 16, 2013, BioInvent International has announced that the April 15, 2013 online issue of Cancer Cell features a data publication demonstrating potent anti-cancer activity of BI-505 in multiple preclinical myeloma tumor models. The product is currently in Phase I clinical testing and the study of BI-505 in patients in advanced stages of the malignant disease multiple myeloma were reported earlier this year. 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.
• On December 12, 2011, BioInvent International has announced that new preclinical data has been presented on its BI-505 programme that demonstrates anti-cancer activity in multiple myeloma and beneficial effect on bone density. The results were presented at the American Society of Hematology (ASH) Annual Meeting, San Diego, USA on Sunday 11 December 2011. The study was conducted by researchers at the University of Utah, Salt Lake City, USA under the direction of Professor Guido Tricot.
Compared to untreated controls, BI-505 treated animals showed a significant reduction (p-value <0.01) of tumour burden induced by primary human multiple myeloma cells as measured by human IgG levels. The active control, bortezomid (Velcade®*, Takeda/ Millennium) also showed significant effect (p-value <0.01) over the placebo control.
A second outcome investigated in the study was bone resorption. This is very important to multiple myeloma patients because, as the disease progresses, lysis, or breakdown, of bone causes increasing pain. This lysis is caused by the shift in balance in favour of osteoclasts, the bone cells in charge of skeletal breakdown, over osteoblasts, bone cells promoting build-up. The study demonstrated that both BI-505 and Velcade had a favourable effect on bone mineral density. In a previous animal model BioInvent has also shown BI-505 to prolong survival compared to Velcade®.
Is
general: Yes
