HDT Bio Launches Canadian Clinical Program for Brain Cancer Treatment

HDT Bio Corp. has established its Canadian subsidiary, HDT Bio Canada Inc., to advance its cancer immunotherapy programs through Canadian clinical development, manufacturing, and regulatory pathways. The company is partnering with McGill University and its research hospital, The Neuro, to conduct a Phase 1 clinical evaluation of HDT-401, an investigational, locally administered immune activator designed for glioblastoma.

HDT-401 has previously been administered to glioblastoma patients under compassionate use protocols, yielding encouraging results that have informed the design of the formal Phase 1 trial. HDT Bio Canada has completed a pre-Clinical Trial Application meeting with Health Canada and is progressing towards CTA submission. This marks a significant step in bringing the novel therapy closer to Canadian patients.

The planned Phase 1 study will be conducted at The Neuro in Montreal, involving clinical and scientific experts from McGill-affiliated institutions. Glioblastoma remains one of the most aggressive and lethal brain cancers, with limited treatment options and a poor prognosis. HDT-401 combines the Riboxxim molecule, licensed from Germany's Riboxx GmbH, with HDT Bio's proprietary LION™ nucleic acid delivery platform, which has a substantial track record from over 6,000 patient treatments in prior clinical programs.

HDT Bio is further demonstrating its commitment to Canada by advancing a breast cancer vaccine program domestically. The company has also secured a manufacturing partnership with Northern RNA Inc. in Calgary for GMP production, bolstering Canada's advanced biomanufacturing capabilities and ensuring Canadian patients can access cutting-edge therapies.