IN 2016, AN ESTIMATED 564,000 CANADIANS SUFFERED FROM DEMENTIA. By 2031, says the Alzheimer’s Society of Canada, that figure will rise to 937,000. In the US it is estimated that the Alzheimer’s burden will triple from 5.3 million people today to 16 million by 2050. Worldwide, nearly 44 million people have or are living with an Alzheimer’s related disease. In 2016, the cost to Canada’s health care system, and to those who live with dementia, was estimated at $10.4 billion. By 2031, that total will likely reach $16.6 billion. In 2014, the direct costs of caring for people living with the disease was estimated to total well over $210 billion in the US.
Clearly, the need to act, to improve treatment and to pursue the eventual prevention of Alzheimer’s disease, is great. Fortunately, while the need is great, so is the response. In the US alone, approximately $991 million was spent on Alzheimer’s disease and dementia-related research in 2016. The Alzheimer’s disease therapeutics and diagnostics market alone reached more $6.7 billion. Among those leading the way is KalGene Pharmaceuticals, a privately held Canadian company working in partnership with leading clinician-scientists and academic institutions. One of the key reasons KalGene believes it is on the road to success, says its president and chief scientific officer, is because the road it has chosen to take accounts for the multiple failures of the past: It must attack the true pathological target, efficiently deliver the drug to the brain and select the patient group by utilizing novel AI technology which can best benefit from the drug treatment.
“It’s true, we have taken a novel approach to slowing down the progression of Alzheimer’s disease,” says Dr. T. Nathan Yoganathan. “A major obstacle to treating neurodegenerative diseases like Alzheimer’s is delivering therapeutics past the blood-brain barrier. Using technology licensed from the National Research Council of Canada, we’re overcoming that obstacle. As a result, our development candidate is able to pass through the blood-brain barrier, rapidly inducing brain and CSF-amyloid-beta clearance. Studies to date have indicated dramatic plaque removal.”
“The treatment we developed at the NRC and licensed to Kalgene is one of the first in the field to effectively deliver Alzheimer’s medicine to the target site inside the brain, using our revolutionary blood-brain barrier carriers, says Dr. Balu Chakravarthy, Team Leader, Central Nervous System Pharmacology at the NRC’s Human Health Therapeutics Research Centre.
KalGene’s work – and its success – has not gone unnoticed. Late last year, the firm received significant financial support from a syndicated investment led by Lumira Capital. Also participating in the transaction were Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices. François Gilbert, CEO of Anges Québec and Anges Québec Capital, explained the decision to support KalGene this way: “We were impressed by the quality of the science behind KalGene and their approach to Alzheimer’s treatments. We know that important challenges lie ahead in this race to tackle Alzheimer’s disease, but we are confident that the KalGene team has what it takes to succeed.”
If Dr. Yoganathan shares that optimism – and he does – he says it’s largely because of KalGene’s ability to attract and work with key partners, including the National Research Council of Canada and McGill University, where a number of the lead clinicians and researchers are located. “The scientists there deserve a lot of credit for what we’ve accomplished,” he says. “No doubt, their contributions have helped us move forward with confidence. The Douglas Hospital is at the forefront of AD clinical research. We will be employing brain imaging and are developing an innovative AI-based approach for patient monitoring which will allow us to progress rapidly, once the therapeutic enters the clinic.”
Dr. John Gillard, KalGene VP, Product Development, is a seasoned researcher and drug developer, he expresses his enthusiasm for the project as a “remarkable example of a collaborative venture, combining the best of Canadian drug design ingenuity with world-leading clinical insight to create a molecule with a real promise, and which I am proud to move forward.” The drug product is being bio-manufactured in Canada using a process developed by the team at the National Research Council Human Health Division in Montreal.
And forward is definitely the direction KalGene is heading. Dr. Yoganathan expects the company to hold the first clinical trial of its Alzheimer’s therapeutic candidate at McGill University in 2019. The company has worked closely with the McGill Centre for Aging over the past 2 years to characterise the molecule in a battery of tests resembling the proposed clinical study. Dr. Pedro Rosa Neto is the Assoc. Director at the Centre for Aging, who will also oversee the clinical trial. He says “We have had contributions from Canada’s leading Brain Research Foundations, Weston Brain Foundation, Ontario Brain Institute (OBI), Brain Canada and CQDM so we understand the workings of this molecule so well now. We have seen success in all the studies to date and we are now actively recruiting patients with the best chance of demonstrating a clinical effect”, He says the safety studies are expected to last about three months, the initial efficacy study a little less than a year.
In the meanwhile, KalGene will continue to pursue the development path it has chosen, confident that its approach towards Alzheimer’s Disease modification is the right one. Not only are we confident that we are headed in the direction, we’re carrying out our studies with the right partners … With the commitment of talented scientists, drug developers and clinicians; and the financial support from our investors, foundations, public agencies and granting sources we’ve created a dynamic biotechnology collaborative program well suited to develop a breakthrough therapy for this terrible disease.
This article was originally published in the Spring 2018 edition of the BIOTECanada Magazine. You can find a copy of the article here: KalGene.BIOTEC