Lund, Sweden – 16 April 2013 – BioInvent International AB (OMXS:BINV), a biotech company developing novel antibody therapeutics for treatment of cancer, today announced that the April 15, 2013 online issue of the highly prestigious cancer research journal Cancer Cell features a data publication demonstrating potent anti-cancer activity of BI-505 in multiple preclinical myeloma tumor models. BI-505 is currently in Phase I clinical testing and is furthest ahead among several novel antibody candidates that have emerged from the company’s unique function-first platform “F.I.R.S.T.?”, which enables combined target and antibody drug discovery.
“BI-505 is BioInvent’s first therapeutic antibody isolated by target unbiased functional screening to enter clinical trials. BioInvent researchers identified this antibody based on its significant ability to confer tumor cell death in preclinical B cell cancer models, amongst tens of billions antibodies present in the company’s human antibody library n CoDeR®”, said Björn Frendéus, Ph.D., Vice President, Preclinical Research of BioInvent International AB and senior author on the paper. “BI-505 binds very specifically to intercellular adhesion molecule 1 (ICAM-1), a receptor which is highly expressed on multiple myeloma cancer cells as well as implicated in myeloma pathogenesis and development of drug-resistance, the current inevitable end-stage of this aggressive disease”.
ICAM-1 is a cell adhesion molecule that has previously been pursued as target for antibody based therapy, but then in chronic inflammatory and autoimmune diseases, based on its well-characterized role in inflammation. Cristina Glad, CEO of BioInvent, said, “BI-505 is one of several antibodies that BioInvent is developing for treatment of cancer. BI-505 induces cell death in target tumor cells and activates host antitumor immunity in a manner that would not have been predicted from currently available information on the biology of ICAM-1. This molecule illustrates how our unique F.I.R.S.T.™ platform broadens the therapeutic target space by uncovering previously unrecognized functions of known targets, pointing to their therapeutic utility in new indications”.
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.
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.
The F.I.R.S.T.™ screening system is based on BioInvent’s n-CoDeR® library and is a proprietary antibody technology for “fishing” library antibodies targeting surface receptors, “antigens”, which show promising characteristics in primary cancer patient cells. This functional approach to target identification allows for the selection of functionally superior high-affinity antibodies at an early stage in the drug discovery process. F.I.R.S.T.™ is an acronym for Functional Interrogation of Recombinant antibody librarieS for Therapeutic candidates. The n-CoDeR® library contains more than 20 billion (2 x 10¹º) highly diverse, fully human antibody fragments.
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 16, 2013.