Wellesley, Mass. — Coley Pharmaceutical Group, here, announced this week (November 25, 2003) that the U.S. Patent and Trademark Office has issued U. S. Patent # 6,653,292 titled “Methods Of Treating Cancer Using Immunostimulatory Oligonucleotides”. The patent broadly protects the use of immune stimulatory CpG oligonucleotides (CpG TLR9 agonists) to treat or prevent cancer or to enhance multimodal cancer treatment regimens.

The patent, according to the company, covers a family of synthetic oligonucleotides that contain CpG motifs. Cancer treatment applications protected by this patent include CpG TLR9 agonist monotherapy and combination therapies where CpG TLR9 agonists are used to enhance the anti-cancer activity of other regimens, including anti-tumor antibodies, chemotherapies, bone marrow transplantation and immunotherapeutic agents.

“This patent is noteworthy in that it protects the use of a wide range ofCpG TLR9 agonist drugs as both monotherapy and as part of multi drug therapyfor cancers,” Robert L. Bratzler, Coley president and chief executive officer, said. “Our lead CpG TLR9 agonist, ProMune(TM), has been administered to over 400 subjects to date and has been shown to have anti-tumor activity in five different cancers. Randomized Phase II trials in melanoma and non-small cell lung cancer are underway.”

The technology covered in patent # 6,653,292 is part of the patent estate licensed by Coley from the University of Iowa and the U.S. National Institutes of Health. A Coley spokesman said that to date the company has been granted 11 U.S. Patents, covering key aspects of the company’s CpG TLR9 antagonist technologies. In addition, Coley has filed more than 76 patent applications in the U.S. and abroad, the spokesman said.

About CpG TLR9 Agonists for Cancers

The use of short, synthetic oligonucleotides, such as Coley’s CpG TLR9agonists, represents a highly specific, targeted approach to stimulating thebody’s immune system to combat disease, to bolstering the efficacy of vaccinesand to redirect inappropriate immune response, the company said in a release. Coley is developing this new class of molecules for the treatment of cancers, Hepatitis C, allergy and asthma, as well as for the improvement of vaccines.

This class of molecules interacts with an innate immune system receptor, Toll-Like Receptor 9 (TLR9), found in certain dendritic cells and B cells, triggering a chemokine and cytokine cascade that activates both the innate and adaptive arms of the immune system for powerful, sustained and targeted immune responses, the company reported.