Dr. Serge Gauthier
Director, AD Research Unit, McGill Centre for Studies in Aging
Dr. Danica Stanimirovic
Director, R&D, NRC’s Human Health Therapeutics Research Centre
Dr. T. Nathan Yoganathan
Executive, KalGene Pharmaceuticals
Dr. Jacki Jenuth
Partner, Lumira Ventures, & Chairperson, Board of Directors, Kalgene Pharmaceuticals
Alzheimer’s disease is the single greatest cause of disability and debilitation in Canada’s senior population, with an estimated half-million people affected. Dementia had a direct cost to Canadians of $8.6 billion in 2018, and in the absence of disease-modifying therapy, it’s predicted to grow to $87.3 billion in 2035, with disproportionately large indirect costs reflecting the huge impact on the lives and productivity of caregivers.
The Canadian national dementia strategy was released in June 2019 and calls for a three-pronged approach that embraces patient care, basic research, and drug development. Our challenge here in Canada is to coordinate our remarkably well-structured and integrated medical system, our world-class academic and clinical capabilities in neuroscience, our creative medical technology and devices sector, and our expertise in artificial intelligence (AI) to leverage clinical breakthroughs in the treatment of Alzheimer’s to craft solutions both nationally and internationally.
The Canadian biotech company KalGene Pharmaceuticals is adopting a broad view of the field as it undertakes its development of a potential disease-modifying drug for Alzheimer’s, currently known as KG207. KalGene is collaborating with the National Research Council of Canada (NRC), where KG207 — a bi-specific fusion protein — was designed to efficiently access and remove the neurotoxic amyloid oligomers that are found in the brains of Alzheimer’s patients.
“NRC innovations that have been incorporated into the design of KG207 will improve brain penetration, accelerate removal of toxic amyloid, and reduce inflammatory responses in the brain. We hope the accelerated efficacy and reduced side effects observed in pre-clinical studies will be translated into the clinical phase,” says Dr. Danica Stanimirovic, R&D Director for the NRC’s Human Health Therapeutics Research Centre.
We’ll be using the most advanced clinical diagnostic techniques […] which are essential elements to conducting successful trials in early Alzheimer’s patients.Dr. Serge Gauthier, Director, AD Research Unit at the McGill Centre for Studies in Aging
“Kalgene’s approach is designed to address significant shortcomings of current antibody-based approaches in the clinic,” says Dr. Jacki Jenuth of Lumira Ventures, Chairperson of Kalgene’s Board of Directors. “KG207, Kalgene’s lead, has been engineered to target toxic soluble oligomeric amyloid while minimizing safety issues associated with edema and micro bleeds. The company will completing its pre-clinical activities next year and will enter the clinic shortly after.”
Dr. John Gillard, a highly experienced Canadian biotech expert and KalGene’s Senior Vice President of R&D, notes: “KG207 avoids the two key limitations that have plagued all antibody-based approaches, including aducanumab: firstly, a mechanism which doesn’t activate the brain’s immune system to remove a range of amyloid species, risking neuro-inflammation, edema, and microbleeds; and secondly, the design of the molecule facilitates crossing the protective membrane, referred to as the blood-brain barrier, permitting improved delivery to the brain and resulting therapeutic effect.”
KalGene executive Dr. T. Nathan Yoganathan notes that, “in collaboration with the NRC we’ve developed a high-yield biomanufacturing process to permit adequate drug supply with reduced costs.”
In order to identify novel and accessible diagnostic approaches, KalGene is working collaboratively with the Pan-Canadian Alliance for AI Based Diagnostic and Treatment for Alzheimer’s (PCAA). PCAA is an alliance of industry players, universities, hospitals, research foundations, and networks working together to create a national ecosystem for accelerating innovations in the diagnosis and treatment of Alzheimer’s disease in Canada.
“To develop a precision medicine for Alzheimer’s,” says Dr. Serge Gauthier, Director, AD Research Unit at the McGill Centre for Studies in Aging, and the co-chair of PCAA, “we need to select early Alzheimer’s patients with amyloid target-dependent disease, whose disease-progression risk can be quantified. We’ll be using the most advanced clinical diagnostic techniques via gold-standard biomarkers, to select amyloid, tau, and other emerging targets, which are essential elements to conducting successful trials in early Alzheimer’s patients.”
According to PCAA industry member Liam Kaufman, Co-Founder and CEO of Winterlight Labs, “Winterlight is excited to work with the alliance to further develop and refine its speech-based digital biomarkers for patient selection and monitoring response-to-therapy in Alzheimer’s disease.” Dr. Mario Masellis from the Sunnybrook Research Institute at the University of Toronto is working with the Alliance to develop new collective AI-based tools with the goal of expanding the diagnosis and management of Alzheimer’s disease and related dementias.
In support of Canada’s national dementia strategy, the alliance will develop a precision medicine framework for Alzheimer’s disease diagnosis, prognosis, prevention, and treatment — leveraging the latest technologies in molecular diagnostics, medical imaging, bioinformatics, and health care analytics.