BioInvent granted US patent for BI-505 and apoptosis-inducing ICAM-1 antibodies

Regulatory News:

BioInvent International (OMXS: BINV) today announced that the company has been granted a US patent covering the antibody drug candidate BI-505, initially in phase II development for the treatment of multiple myeloma. The patent has broad coverage and protects development of any apoptosis-inducing ICAM-1 antibody.

We are very pleased to get this important patent granted in the U.S. It provides broad protection for BI-505 which was developed using our unique target and antibody drug discovery platform F.I.R.S.T™,” said Björn Frendéus, BioInvent´s Chief Scientific Officer . "With many targets being known, securing robust intellectual property is presently a major challenge in drug-development. This patent is based on the discovery of novel functions of a known target and demonstrates our ability to identify competitive antibodies and generate IP using the F.I.R.S.T™ platform”.

To the editors:

About BI-505

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 elevated in tumour cells, which makes it a suitable target for a candidate drug. BI-505 has a new mechanism involving induction of programmed cell death (apoptosis) of myeloma cells and triggering of patient's immune cells, macrophages, to attack and kill myeloma cells. In several animal models, BI-505 proved to be very effective at killing tumours and more effective than existing drugs.

BI-505 has received Orphan Drug Designation in both Europe and the US for the indication multiple myeloma. This provides BI-505 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 number of newly diagnosed patients with multiple myeloma worldwide is estimated at more than 40,000 per year.

A phase I study of BI-505 on patients in advanced stages of the malignant disease multiple myeloma was reported in January 2013. BI-505 showed a good safety profile and in those dosage groups to which extended therapy was offered, 24% of these severely ill patients demonstrated stable disease for at least two months, indicating a beneficial effect of BI-505. Optimal dose was determined according to the study protocol and will be used in forthcoming clinical trials.

BI-505 has the potential to be developed both as mono therapy and combination therapy. BioInvent intends to find a development partner for BI-505 and to take a strategic decision on continued product development in cooperation with that partner.

About F.I.R.S.T™

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, that show the most promising characteristics in primary patient cancer or immune cells. Antibodies may exert their therapeutic function by targeting ligand-receptor signalling pathways (target biology) and dynamic triggering of patient’s own anticancer immune defence mechanisms (antibody biology). F.I.R.S.T™ allows for the selection of functionally superior high-affinity antibodies based on both target and antibody biologies 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. BI-505 is the furthest advanced antibody out of several that have emerged from the F.I.R.S.T™ platform.

About BioInvent

BioInvent International AB (STO:BINV) is a research-based pharmaceutical company focused on discovery and development of innovative antibody-based drugs against cancer.

The company has unique expertise in antibody drug development from initial concept to late clinical phase. The screening tool F.I.R.S.TTM and the antibody library n-CoDeR® are two patented tools that enable identification of relevant human antibodies and disease targets during the discovery phase. The scope and strength of this platform is also used to develop antibody-based drugs in collaboration with partners who finance the development of new drugs, and provide BioInvent with the right to milestone payments and royalties on sales. These partners include Bayer Pharma, Daiichi Sankyo, Les Laboratoires Servier and Mitsubishi Tanabe Pharma. More information is available at www.bioinvent.com.

The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way 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.

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