Alethia BioTherapeutics, Inc. Announces in-Licensing of a Peptide for Imaging of Solid Tumors in vivo and Positive Pre-Clinical Results of AB-16B5 in Prostate and Breast Cancer

MONTREAL, QUEBEC--(Marketwire - December 07, 2009) - Alethia Biotherapeutics Inc., a privately held biotechnology company, announced today that it has obtained from the National Research Council Biotechnology Research Institute (NRC-BRI) the exclusive worldwide diagnostic rights to a peptide that specifically binds to tumor-associated clusterin.

This peptide was identified by phage display and shown to be a strong and specific binder of human clusterin as measured using sensitive methods such as nuclear magnetic resonance and surface plasmon resonance. The ability of the peptide, designated P3378, to specifically home to and image tumors in vivo when fluorescently labeled with a Near Infra Red probe was demonstrated by real-time imaging on live tumor-bearing mice.

"With the perspective of initiating clinical studies in the near future, we felt it was important to undertake the development of a companion diagnostic test with the goals of accurately identifying the cancer patients who would benefit the most from an anti-clusterin-based therapy and a monitoring of response to treatment. This peptide constitutes the basis for the development of a new molecular imaging tool that will accurately detect tumor-associated clusterin in cancer patients," said Mario Filion, Ph.D., Executive VP and Chief Scientific Officer of Alethia.

This transaction with the NRC-BRI follows a previous license agreement concluded in October 2007 concerning a family of monoclonal antibodies (mAbs) that bind specifically to tumor-associated clusterin. Clusterin secreted from cancer cells has recently been identified as a potent inducer of the epithelial-to-mesenchymal transition (EMT), a process that contributes to metastatic invasion of tumors. The lead mAb product, AB-16B5, is currently in pre-clinical development in several animal models of metastatic cancer, including invasive breast cancer and hormone-resistant prostate cancer. To date, studies revealed that treatment of tumor-harboring mice with AB-16B5 reduced the growth of tumors in combination with chemotherapy. These findings are in complete agreement with the predicted role of tumor-associated clusterin as a potent inducer of chemo-resistance in tumor cells. Additionally, AB-16B5 effectively reduced the spread of tumor cells to secondary organs such as the lungs and the bones, confirming the ability of this anti-clusterin mAb to inhibit EMT in vivo.

"The concept that EMT is an important cellular mechanism leading to tumor progression is now widely accepted. Tumor-associated clusterin is emerging as one the most specific regulators of EMT and AB-16B5 is one of the rare therapeutic mAbs that directly targets this important biological process. Its therapeutic effects hold much promise to control metastasis from breast and prostate tumors, in addition to enhancing the response to chemotherapeutic drugs. With the recent progress accomplished in this therapeutic program, Alethia is now at the doorstep of IND filing," added Mario Filion.

"We are very pleased about this new transaction with the NRC-BRI. The addition of this imaging peptide to our mAb product portfolio consolidates our position in the development of targeted therapies and underscores the increasing importance of offering personalized medicine solutions to health care providers," said Yves Cornellier, Alethia's President and Chief Executive Officer.

About Alethia Biotherapeutics Inc.

Alethia is a privately held, Montreal-based biotechnology company that was created in 2002. Alethia is developing innovative therapeutic approaches in areas of unmet medical needs. The Company is currently focusing on cancer-associated epithelial-to-mesenchymal transition, ovarian cancer, and on cancer-induced bone loss, three areas for which there are very few therapeutic options. Alethia capitalizes on its capacity to identify and validate disease-specific targets for the development of highly focused monoclonal-based therapeutics.