Cytheris Announces Notice of Allowance for U.S. Patent Covering its IL-7

10-Jul-2009 - France

Cytheris SA announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "IL-7 Drug Substance, Composition, Preparation and Uses", US Patent Application Number 10/522,883. The Notice of Allowance is the USPTO's official communication that the Company's application has successfully completed examination and that a patent will be issued.

"Once issued, this patent along with other previously issued patents will provide broad protection for Cytheris' recombinant human interleukin-7 (CYT107), a critical immune-modulator for immune T-cell recovery and enhancement, and extend this protection in the U.S. to 2022," said Michel Morre, DVM, President and CEO of Cytheris.

This patent covers the efficient IL-7 pharmaceutical composition which should contain not only the specific IL-7 conformer as the major constituent, but should also be essentially devoid of other conformers or IL-7 molecular variants, previously considered as active products. The patent incorporates the combination of all this information as necessary to design and produce an ideal IL-7 pharmaceutical composition. The patent stems from the unexpected discovery that the long term activity of recombinant IL-7 is mostly expressed by a specific conformer and that other conformers, potential product-related substances, product-related impurities, and process-related impurities, which would normally be included in the specification of the drug substance and/or drug product, although bioactive, should be strictly minimized because they are able to trigger an immune reaction against the desired IL-7 molecule.

Considerable evidence from basic immunology, preclinical models and, more recently, from clinical studies, confirms the unique role of IL-7 in the functioning of the immune system and especially in providing the right cells in sufficient numbers to support and improve specific immune responses against infectious agents and malignant cells. In that light, as with EPO for red blood cells and G-CSF for neutrophils, IL-7 plays a pivotal role in supporting T cell expansion and function.

IL-7 was originally discovered by Immunex Corporation (now part of Amgen) and through a process of intellectual property acquisition resulting from several mergers, the compound eventually ended up at what is today Sanofi-Aventis, from whom Cytheris holds the exclusive worldwide license. Cytheris also holds the rights to an additional IL-7 patent family acquired under an exclusive worldwide license from the Washington Research Foundation of the University of Washington, Seattle.

As the exclusive licensee, Cytheris holds all original patents protecting IL-7 and various uses including the use for T cell expansion and for enhancing humoral and cellular immunity.

In addition Cytheris has filed patent applications protecting the purified protein as a drug substance for therapeutic use with the correct disulfide bridging, the appropriate glycosylation profile and polypeptidic purity. These patents also protect various hyperglycosylated analogs and various fusion proteins.

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