The initiative marks the debut of HDT Bio Canada Inc., a subsidiary focused on localizing clinical development, regulatory navigation, and manufacturing. HDT-401 is designed to be injected directly into the tumor bed or surgical cavity, aiming to transform the tumor’s immunosuppressive environment into one that triggers an active immune response. By concentrating the treatment at the site of the disease, researchers hope to recruit immune effector cells while minimizing the systemic side effects that have hampered previous immunotherapies.
Dr. Roberto Diaz, a lead investigator at The Neuro of McGill University, noted that the current standard of care—resection followed by radiation and chemotherapy—is insufficient against the aggressive nature of the disease. Early data from compassionate use protocols served as the foundation for the upcoming Phase 1 trial, which has already cleared initial consultations with Health Canada. The program utilizes a combination of Riboxxim, an engineered molecule from Germany’s Riboxx GmbH, and HDT Bio’s proprietary LION nucleic acid delivery platform, which has been tested in over 6,000 patients across various studies.

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