Lund, Sweden – 22 April 2013 - BioInvent International (OMXS:BINV) announced today that the first patient has been treated in a phase II study of the drug candidate BI-505, developed for the treatment of multiple myeloma. The study is conducted in patients with asymptomatic myeloma (called “smoldering multiple myeloma”). Smoldering myeloma patients have not developed symptoms of disease and the condition can be detected only in laboratory tests. The current study involves up to 10 patients and evaluates disease activity following treatment with BI-505. Secondary objectives include safety, pharmacokinetics and assessment of biomarkers.
Cristina Glad, CEO of BioInvent, commented: “BI-505 is one example of BioInvent's capability to initiate in-house clinical projects, based on our own F.I.R.S.T™ technology and biological expertise. The first clinical study of BI-505 achieved our goals. The candidate drug was well tolerated and indicated therapeutic effect, since seven of a total of 29 patients with advanced multiple myeloma demonstrated stable disease for at least two months. The start of this phase II study is another important step forward for BI-505 and we believe that BI-505 has the potential to address a major unmet need in a broad population of patients.”
The candidate drug BI-505 is a human antibody that specifically binds to the ICAM-1 adhesion protein (also known as CD54). Expression of ICAM -1 is increased on myeloma cells, which makes it a suitable target for a candidate drug. BI-505 exerts its antimyeloma activity by inducing 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. Preclinical data also demonstrate significantly enhanced anti-myeloma activity when the approved drugs Velcade® or Revlimid® is combined with BI-505 compared to single agent treatment.
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. 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.
The number of newly diagnosed patients with multiple myeloma worldwide is estimated to more than 40,000 per year.
BI-505 has received Orphan Drug Designation in both Europe and the US for the indication multiple myeloma. This provides BioInvent with market exclusivity for treatment of multiple myeloma with an antibody against ICAM-1 for up to 10 years after marketing approval is granted.
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company focused on discovery and development of innovative antibody-based drugs against cancer. The Company's pipeline currently includes three product candidates for the treatment of cancer.
The company's competitive position is underpinned by n-CoDeR®, a proprietary antibody development platform. The scope and strength of this platform is also used to develop antibody-based drugs in collaboration with partners who finance the development of the new drug, and provide BioInvent the right to milestone payments and royalties on sales. These partners include Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe and Servier. More information is available at www.bioinvent.com.
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The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same was as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Information disclosed in this press release is provided herein pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 8.30 a.m. CET on April 22, 2013.