HDT Bio Canada Inc. partners with McGill University and The Neuro to advance HDT-401, an investigational locally administered RNA immune activator, into Phase 1 clinical evaluation for glioblastoma in Canada

MONTREAL and SEATTLE, July 12, 2026 /PRNewswire/ — Among the deadliest of brain cancers, glioblastoma kills virtually everyone diagnosed, and usually within 15 months. Decades of research have produced virtually no improvement. No approved immunotherapy has ever demonstrated a survival benefit.

That may be about to change. HDT Bio Corp. has announced 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. 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 program toward CTA submission.

The planned Phase 1 study will be conducted in collaboration with Roberto Diaz, MD, PhD of The Neuro of McGill University at, along with clinical and scientific experts across McGill-affiliated institutions in Montreal. “When you operate on these patients, you understand the problem in a way that is difficult to convey. You resect what you can. You know what remains. And you know the current tools are not enough,” said Dr. Diaz. “This program is about changing that.”

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. The LION™ platform has been evaluated in more than 6,000 patients across multiple clinical programs, providing an extensive foundation of clinical experience.

“Glioblastoma patients have waited decades for something new,” said Steven Reed, PhD, Chief Executive Officer of HDT Bio Corp. “We have treated patients with HDT-401 under compassionate use. What we observed was encouraging. That is why we are moving as fast as we can to get this into a formal trial in Canada, with one of the world’s great brain cancer research teams. Our commitment to Canada is significant. We are developing products here, working through Canadian regulatory pathways, and supporting Canadian manufacturing capability. Canadian patients and Canadian science are at the center of this program.”

HDT-401 is designed to activate innate immune sensing directly within the tumor 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 tumor tissue. Local administration into the tumor or surgical cavity concentrates immune activation at the site of disease while limiting systemic exposure.

“Riboxxim was engineered to solve a problem that earlier TLR3 agonist technologies have never fully addressed: precise, reproducible immune activation without the unpredictability that limited clinical developments and market access. HDT Bio’s approach of delivering Riboxxim is scientifically compelling because it concentrates immune activation exactly where it is needed most,” said Prof. Dr. Jacques Rohayem, CEO of Riboxx and the inventor of Riboxxim. “The formulation expertise at HDT Bio has contributed an important step in enabling Riboxxim to become a product that can have a major impact on the treatment of glioblastoma and other cancers. I am pleased to see it advancing to the clinic.”

“Glioblastoma remains one of the most difficult cancers to treat because recurrence is common and the tumor environment actively suppresses immune activity,” said Roberto Diaz, MD, PhD of McGill University. “These are real patients with no good options. The tumor’s ability to suppress immune activity locally is one of the central reasons it has resisted every treatment we have thrown at it. An approach that targets that immunosuppressive environment directly, at the tumor bed, is where the science points. That is why I am committed to this program.”

HDT Bio is also advancing a breast cancer vaccine program in Canada, reflecting the company’s broader commitment to Canadian patients and Canadian clinical infrastructure. For that program, the company has engaged Northern RNA Inc. of Calgary as its Canadian GMP manufacturing partner. Northern RNA is a world-class nucleic acid contract manufacturer.

“This is exactly the kind of program Northern RNA was built to support,” said Jared Davis, President and CEO of Northern RNA Inc. “Canadian patients with glioblastoma deserve access to the most innovative treatments being developed anywhere in the world. Manufacturing in Canada, for Canadian patients, with a Canadian clinical partner, is how we help make that happen. We are proud to be part of HDT Bio’s Canadian commitment.”

About Glioblastoma Glioblastoma is the most common and aggressive primary malignant brain tumor in adults. The five-year survival rate is below 5 percent. Standard treatment includes maximal safe surgical resection, radiation therapy, and temozolomide chemotherapy, but recurrence is common and survival remains limited. No approved immunotherapy has demonstrated a survival benefit in glioblastoma to date. Despite its devastating prognosis, glioblastoma receives significantly less research funding than other cancers of comparable lethality, leaving patients with few meaningful treatment advances and an urgent need for innovative clinical approaches. The glioblastoma treatment market exceeds $3 billion annually and is projected to reach $4.46 billion by 2030, underscoring both the scale of the disease burden and the commercial opportunity for effective new therapies.

About HDT-401 HDT-401 is an investigational immune activator designed for local administration into the tumor or surgical cavity. It combines Riboxxim, a precisely engineered TLR3/RIG-I agonist licensed from Riboxx GmbH, with HDT Bio’s proprietary LION™ lipid delivery platform. HDT-401 is intended to stimulate innate immune pathways, promote inflammatory signaling in the tumor microenvironment, and recruit immune cells to support anti-tumor activity. HDT-401 has not been approved by Health Canada, the U.S. Food and Drug Administration, or any other regulatory authority.

About HDT Bio Corp. HDT Bio Corp. is a clinical-stage biotechnology company developing next-generation RNA and immune-activation technologies for oncology and infectious disease. The company’s platforms are designed to enable targeted immune responses across multiple therapeutic areas, including solid tumors and cancer vaccines. The company’s LION™ nucleic acid delivery platform has been evaluated in more than 6,000 patients across multiple clinical programs. HDT Bio Corp. is headquartered in Seattle, Washington.

About HDT Bio Canada Inc. HDT Bio Canada Inc. is HDT Bio Corp.’s Canadian subsidiary, established to advance the company’s Canadian clinical, manufacturing, and regulatory activities. HDT Bio Canada is based in Montreal, Quebec.

About The Neuro (Montreal Neurological Institute-Hospital) The Montreal Neurological Institute-Hospital, known as The Neuro, is a world-leading destination for brain research and advanced neurological care, affiliated with McGill University and the McGill University Health Centre. The Neuro is Canada’s largest university-based research and clinical center dedicated to the study and treatment of the nervous system and its diseases, and is home to internationally recognized expertise in neuro-oncology including glioblastoma.

About McGill University McGill University is one of Canada’s leading research-intensive universities, consistently ranked among the top universities in the world. Located in Montreal, Quebec, McGill attracts students, faculty, and researchers from around the globe and is internationally recognized for excellence in medicine, life sciences, and biomedical research.

About Northern RNA Inc. Northern RNA Inc. is a Calgary, Alberta-based contract development and manufacturing organization specializing in GMP-grade nucleic acid products including mRNA, plasmid DNA, lipid formulations and drug product fill and finish. Northern RNA is committed to building world-class Canadian biomanufacturing capacity in support of Canada’s life sciences sector.

About Riboxx GmbH Riboxx GmbH is a Dresden, Germany-based biotechnology company focused on the development of immune activators such as Riboxxim, targeted to Toll-like Receptors. Riboxxim, its lead molecule, is a chemically defined TLR3/RIG-I agonist engineered for reproducible and precise immune activation with optimal safety-efficacy profile and is manufactured under a GMP process. Riboxxim is licensed to HDT Bio Corp. for use in HDT-401.

Forward-Looking Statements This press release contains forward-looking statements regarding HDT Bio’s clinical development plans, regulatory engagement, and intended initiation and conduct of clinical trials, including those concerning HDT-401. Such statements are based on management’s current expectations and are subject to risks and uncertainties, including delays in regulatory review, clinical trial initiation, enrollment or outcomes, manufacturing or supply considerations, and the receipt of required regulatory and institutional approvals. Actual results may differ materially from those expressed or implied. HDT Bio undertakes no obligation to update any forward-looking statement except as required by law.

Contact:

David Lapointe

HDT Bio Canada, Inc.

david.lapointe@hdt.bio

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SOURCE HDT Bio Corp.