Canadian biotechnology firm Alethia Biotherapeutics has submitted a clinical trial application (CTA) seeking approval from Health Canada to begin a Phase I clinical trial with AB-16B5, a fully humanised monoclonal antibody, to treat patients with advanced solid tumours.
The Phase I trial of AB-16B5, which inhibits epithelial to mesenchymal transition (EMT), will be conducted in these patients.
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Dosing is expected to start in the second quarter of 2015, while the trial is designed to address safety, tolerability and pharmacokinetics across multiple ascending doses of AB-16B5.
Alethia Biotherapeutics CEO Yves Cornellier said: "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."
IBC Generium chief business officer Daniil Talyanskiy said: "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."
The trial design also permits evaluation and monitoring of both pharmacodynamic biomarkers of EMT and circulating tumour cells.
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By GlobalDataAB-16B5 is developed as part of collaboration between Alethia and the National Research Council of Canada (NRC).
Alethia chief scientific officer Dr Mario Filion said: "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 tumour 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 tumour cancer."
AB-16B5 targets secreted clusterin, an important extracellular inducer of EMT, and researchers from NRC’s Biologics programme were the first to identify secreted clusterin as a target for therapeutic antibodies.
