Alethia Biotherapeutics Submits a Clinical Trial Application (CTA) for a Phase I Study with AB-16B5, an Inhibitor of EMT in Patients with Advanced Cancers

20 February 2015

Alethia Biotherapeutics Inc., a privately held biotechnology company, announced that it has submitted a Clinical Trial Application (CTA) with Health Canada to initiate a Phase I clinical trial with AB-16B5, a fully humanized monoclonal antibody that inhibits epithelial to mesenchymal transition (EMT). 
The Phase I clinical trial will be conducted in patients with advanced solid tumors and the Company expects to initiate dosing in 2Q 2015. 
We are extremely pleased to have achieved this important milestone in the development of AB-16B5 and to continue to advance this promising antibody product in collaboration with our strategic partner, IBC Generium ,” stated Yves Cornellier, CEO of Alethia Biotherapeutics. 
The rapid progress Alethia and IBC Generium have made to advance AB-16B5 to this milestone is a testament to the quality of our partnership" commented Daniil Talyanskiy, Chief Business Officer at IBC Generium. The phase I study is designed to address safety, tolerability and pharmacokinetics across multiple ascending doses of AB-16B5. The design also permits for the evaluation and monitoring of both pharmacodynamic biomarkers of EMT and circulating tumor cells. 
Dr. Mario Filion, Chief Scientific Officer commented: “Based on the results of our pre-clinical studies, we believe inhibiting EMT with AB-16B5 may both enhance the response to chemotherapy, by addressing a major mechanism of resistance, and reduce tumor invasion. Our hope is that these characteristics will translate into clinical benefit and that AB-16B5 will address a significant unmet medical need in patients who suffer from an advanced solid tumor cancer”.

About AB-16B5 
AB-16B5 is a fully humanized monoclonal antibody developed from a collaboration between Alethia and the National Research Council of Canada (NRC) in Montreal. AB-16B5 targets secreted clusterin, an important extracellular inducer of EMT, and it was researchers from NRC’s Biologics program who were the first to identify secreted clusterin as a target for therapeutic antibodies. There are significant published reports indicating that tumor cell EMT has an important role in cancer progression. EMT enables epithelial tumor cells that were previously noninvasive and non-metastatic, to move from the primary tumor, invade surrounding tissues, and enter the bloodstream where they disseminate and proliferate at secondary sites. In addition, epithelial cancer cells that undergo EMT gain characteristics that are similar to cancer stem cells, including resistance to cytotoxic chemotherapy- and radiotherapy. 

About Alethia Biotherapeutics Inc. 
Alethia is a privately held biotechnology company based in Montreal. Alethia develops monoclonal antibody therapeutics against novel clinically relevant targets identified using its patented STAR discovery technology. In addition to AB-16B5, Alethia is developing AB-25E9, a first-in-class bone anti-resorptive for the treatment of cancer￾induced bone loss as well AB-3A4, an antibody drug conjugate for the treatment of ovarian cancer and triple-negative breast cancer. Alethia is funded with top-tier investors committed to the success of the Company notably, Agechem Venture Fund, BDC Capital and GO Capital.

About IBC Generium 
The International Biotechnology Center “Generium”, (LLC IBC Generium) is a private scientific research and development company founded in Russia in 2011. IBC Generium is a rapidly growing company with current portfolio of more than 30 innovative biotechnology-based medications and cell-based technologies. IBC Generium is oriented on international collaboration and exchange of experience for new discoveries

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