PARIS ¿ ExonHit Therapeutics SA entered an alliance with BioMirieux-Pierre Fabre for the development of ExonHit¿s cancer diagnostic, Proof-Hit, in the breast and colon cancer areas.

Proof-Hit is a set of molecular cancer diagnostic tools designed to identify which patients at advanced stages of cancer will respond to conventional or novel chemotherapy treatment regimens. Proof-Hit is ExonHit¿s leading pharmacogenomics product and is based on the company¿s DATAS technology (differential analysis of transcripts with alternative splicing). It is in clinical trials and ExonHit said it hopes to have the product on the market by 2004.

Under the agreement, Paris-based ExonHit will apply its DATAS technology to Lyon, France-based BioMirieux¿s clinical collections of biopsies and blood samples taken from patients with breast or colon cancer to define genetic signatures that will then be compiled on its Proof-Hit macroarrays. The signatures allow for the characterization of specific cancers present in the tissues and the determination of an individual patient¿s response to a given treatment in advance.

ExonHit CEO Bruno Tocqui told BioWorld International that the deal called for the development of 12 diagnostic products and said the first should reach the market by 2005. The agreement provides for all the data generated by ExonHit Therapeutics to be exclusively licensed to BioMirieux for the commercialization of Proof-Hit diagnostic products, while ExonHit will receive research and development payments and milestones, as well as royalties on the sale of those products.

Tocqui explained that the deal was, to some extent, the downstream component of ExonHit¿s research collaboration with the Paris-based medical establishment, Institut Curie. Under an agreement signed last April, Curie is helping ExonHit validate Proof-Hit genetic signatures in breast cancer patients to demonstrate its ability to diagnose the disease, prognosticate its development and predict patients¿ response to treatment.

Tocqui said the ultimate objective of the collaboration with BioMirieux is to generate diagnostics that will contribute to the discovery and development of personalized therapies for cancer. ExonHit is developing two compounds for the treatment of cancer, EHT-101 and EHT-102, the first of which is due to enter Phase I trials in 2003.

BioMirieux-Pierre Fabre focuses on seven therapeutic fields, including cancer and cardiovascular disease. In late November, it concluded a research collaboration agreement with another French biotechnology firm, Genfit SA, of Lille, for the identification of molecular mechanisms of action of new drug candidates for cardiovascular disease.

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