Washington Editor

Alethia Biotherapeutics Inc. has entered into a licensing agreement with Canada's National Research Council Biotechnology Research Institute (NRC-BRI) for the worldwide therapeutic and diagnostic rights to Clusterin-specific antibodies.

Under the deal, Alethia will obtain a family of high-affinity antibodies that block the function of secreted Clusterin to prevent tumor invasion.

The Montreal-based company also is gaining access to the NRC-BRI's expertise in the humanization and production of therapeutics antibodies, which will aid the firm in accelerating the development of the monoclonals to the clinical stage, Mario Filion, Alethia's executive vice president and chief scientific officer, told BioWorld Today.

Financial terms of the deal were not disclosed.

Clusterin, a secreted glycoprotein that is implicated in several physiological processes ranging from chaperon action to apoptosis regulation, has been studied for over a decade, but its implications as an oncology target only now are starting to emerge, Filion said.

Increasing evidence points to epithelial-to-mesenchymal transition (EMT) as a possible mechanism responsible for tumor invasion, or metastasis, he said.

During EMT, a process normally involved in embryogenesis and wound healing, epithelial cells lose adherence, become migratory and change into mesenchymal cells that display properties that facilitate the invasion of tumors to other sites.

Secreted Clusterin, according to NRC-BRI, a Canadian governmental organization, not only is stimulated, but directly implicated in EMT.

"This link between EMT and Clusterin is new," Filion added.

Clusterin, he explained, represents a novel target for EMT transition. NRC-BRI researchers have identified the region of Clusterin directly involved in EMT, and monoclonal antibodies targeting that part of the protein have shown efficacy in animal models of metastatic breast cancer, Filion noted.

Alethia will use NRC-BRI's research as a foundation for further preclinical and clinical development of anti-Clusterin antibodies, he said.

Alethia plans to develop the antibodies to target breast cancer, Filion said. Secondary targets the firm is considering for future study for the anti-Clusterin antibodies include cancers of the lung and colon, he added. Alethia hopes to have a compound ready for testing in Phase I clinical trials in about two years, Filion said.

It is the second deal in as many days focused on the newly developing EMT market. Melville, N.Y.-based OSI Pharmaceuticals Inc. and AVEO Pharmaceuticals, of Cambridge, Mass., announced a deal Monday to develop therapies to target the underlying mechanisms of EMT in cancer. (See BioWorld Today, Oct. 3, 2007.)

Under that deal, AVEO will provide OSI access to its databases of tumor targets focusing on tumor maintenance genes that drive EMT. AVEO also is providing OSI access to its Human Response Prediction platform to discover drug compounds targeting EMT.

The Alethia licensing agreement with NRC-BRI complements Alethia's current development programs focusing on ovarian cancer and severe bone loss due to metastatic cancer, Filion said.

In March, Alethia announced that it had entered into a deal with San Diego-based BioSite Inc. to develop recombinant monoclonal antibodies against ovarian cancer targets. (See BioWorld Today, March 14, 2007.)

Alethia, a privately-held firm founded in 2002, also is engaged in the preclinical development of Isogranulatimide, a chemosensitizer to improve the response of tumors to chemotherapeutic drugs in ovarian and colorectal cancer.

"We now have convincing in vivo studies that confirm Isogranulatimide's function as a chemosensitizer," Filion said.

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