US-based clinical-stage biotechnology company HDT Bio Corp announced on Sunday the establishment of HDT Bio Canada Inc, its Canadian subsidiary, formed to advance its cancer immunotherapy programs through Canadian clinical development, Canadian manufacturing, and Canadian regulatory pathways.

The company has partnered with McGill University and The Neuro (Montreal Neurological Institute-Hospital) for the clinical development of HDT-401, its investigational locally administered immune activator for glioblastoma.

HDT-401 has already been administered to glioblastoma patients under compassionate use protocols. According to the company, the results were encouraging enough to inform and shape the design of a formal Phase 1 clinical trial. HDT Bio Canada has completed a pre-Clinical Trial Application meeting with Health Canada, a required regulatory step on the path to trial initiation, and has received constructive feedback that advances the programme toward CTA submission.

HDT-401 combines Riboxxim, a precisely engineered molecule licensed from Riboxx GmbH of Dresden, Germany, with HDT Bio's proprietary LION nucleic acid delivery platform. It is designed to activate innate immune sensing directly within the tumour bed, converting the glioblastoma microenvironment from immune-suppressed to immune-engaged. The approach is intended to induce inflammatory cytokines, recruit immune effector cells, and support local immune recognition of tumour tissue. Local administration into the tumour or surgical cavity concentrates immune activation at the site of disease while limiting systemic exposure.