Corporate | 6 February 2012 07:10

WILEX AG receives funding from the German Federal Ministry of Education and Research for the development of WX-037 as part of the ‘m4 cluster initiative’

WILEX AG / Key word(s): Agreement/Research Update

06.02.2012 / 07:10

PRESS RELEASE

WILEX receives funding from the German Federal Ministry of Education and Research for the development of WX-037 as part of the 'm ⁴ cluster initiative'

Munich, Germany, 06 February 2012. WILEX AG (ISIN DE0006614720 / WL6 / FSE) today announced that it has been granted funding of up to EUR 2.6 million from the German Federal Ministry of Education and Research (BMBF) for the pre-clinical and clinical development of its PI3K inhibitor WX-037. The money will be provided as part of the Munich Leading-Edge Cluster initiative 'm ^4- – Personalised Medicine and Targeted Therapies'.

WILEX will use the grant to continue the pre-clinical development work for WX-037 and prepare clinical Phase I trials. The oral substance WX-037 has been defined as the lead compound for the PI3K inhibitor project. Initial pre-clinical toxicity studies as well as GMP (Good Manufacturing Practice) synthesis and development have already been completed. In the project, WX-037 is to be tested in pre-clinical models as a monotherapy and in combination with the MEK inhibitor WX-554 prior to clinical development in cancer patients.

Dr. Paul Bevan, Head of Research and Development and member of the Executive Management Board of WILEX AG, commented: 'We are delighted to have a project that could make a key contribution in the m ⁴ leading-edge cluster. We believe that our product candidates WX-037 and WX-554 have excellent therapeutic potential and we look forward to moving the PI3K inhibitor into clinical development. Funding from the BMBF will support us in developing this targeted approach to tumour therapy.'

Both small-molecule inhibitors were brought into the WILEX development portfolio in 2009 as part of the strategic alliance with UCB Pharma S.A. WILEX completed the Phase I programme in healthy volunteers with the MEK inhibitor WX-554 and is preparing a Phase Ib/ll trial in cancer patients. WX-554 and WX-037 inhibit different signal pathways that play a significant role in tumour growth, and may be developed in indications such as cancer of the lung, liver, intestine, kidney or breast.

This project provides an opportunity to draw on a range of partnerships between institutions within the scope of the m ⁴ cluster of 'Personalised Medicine'. The biobank and biomarker network may be deployed in trials to demonstrate the overexpression of the PI3K and MEK kinase signal transduction pathways and to develop patient selection. The project may also utilise the infrastructure of the m⁴ Trial Service Center and host patient trials at this centre.

About the Munich Biotech Cluster m ⁴ and the BMBF Leading-Edge Cluster Competition
A number of biotechnology and pharmaceutical companies, hospitals and research institutes within the Greater Munich area have joined forces with the BioM cluster management company in a joint initiative that will use the strategy model 'm ⁴ – Personalized Medicine and Targeted Therapies – A new dimension in drug development' to overcome the core challenges and issues surrounding modern drug development processes. Having all parties collaborate in a network from an early stage is intended to make the development, review and approval of targeted drugs more efficient. The m ⁴ cluster was one of the second-round winners in the Leading-Edge Cluster Competition in 2010. Funding of around EUR 40 million granted by the Federal Ministry of Education and Research will be matched by participating industry partners contributing at least the equivalent amount from their own resources. Bavaria is providing state funding of EUR 2 million for cluster management development and also making another EUR 8.5 million available for a state-wide pre-seed funding programme for personalised medicine (m ⁴ Award). Over the next five years, this means that almost EUR 100 million will be available for developing Munich into an 'International Center of Excellence in Personalized Medicine and Targeted Therapies' – safeguarding and improving the region's ability to compete sustainably, attract international interest and maintain growth. Further information: www.m4.de and www.spitzencluster.de.

About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company's therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma GmbH gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX's customers and partners include leading international pharmaceutical companies. Website: http://www.wilex.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6

Kontakt
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 Munich, Germany
Phone: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com

This communication contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as 'estimates', 'believes', 'expects', 'may', 'will' 'should' 'future', 'potential' or similar expressions or by a general discussion of the Company's strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

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Language:	English
Company:	WILEX AG
	Grillparzerstr. 10
	81675 München
	Germany
Phone:	+49 (0)89 41 31 38 – 0
Fax:	+49 (0)89 41 31 38 – 99
E-mail:	info@wilex.com
Internet:	www.wilex.com
ISIN:	DE0006614720
WKN:	661472
Listed:	Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart

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