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.
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.
AB-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.