28 minute read
REGIONAL SPOTLIGHT RÉGION EN VEDETTE ATLANTIC PROVINCES PARTNER TO CREATE ATLANTIC CLINICAL TRIALS NETWORK
Atlantic Provinces Partner to Create Atlantic Clinical Trials Network Les provinces de l’Atlantique s’associent pour créer le Réseau d’essais cliniques de l’Atlantique
ON JUNE 14, 2022, SENIOR LEADERS FROM THE FOUR ATLANTIC PROVINCES JOINTLY ANNOUNCED THE Atlantic Clinical Trials Network (ACTN) at the BIO International Convention in San Diego, the world’s largest event focused on biotechnology.
Driven by agility and the ability to get the right partners to the table at the right time, ACTN is creating a single point of entry for researchers, partners, and patients. Initiated by Nova Scotia Health and co-led with IWK Health, Eastern Health, Vitalité Health Network, Horizon Health Network, and Health PEI, the network is focused on boosting research and innovation, bringing new healthcare opportunities to those living in the region, and positioning the region as a world-leader in clinical trials.
Michelle Thompson, Minister of Health and Wellness for Nova Scotia, Dr. Andrew Furey, Premier of Newfoundland and Labrador, Dennis King, Premier of Prince Edward Island, and Dorothy Shepard, Minister of Health for New Brunswick were on hand at the convention to speak about the value of this regional partnership in attracting clinical trials investment in Atlantic Canada.
“We are pleased to partner with our Atlantic colleagues to further important research that will benefit Atlantic Canadians and people around the world,” said Minister Thompson. “Innovation drives research and better outcomes for patients. This partnership will support the best talent, create new opportunities for clinicians and
LE 14 JUIN 2022, LES HAUTS DIRIGEANTS DES QUATRE PROVINCES DE L’ATLANTIQUE ONT ANNONCÉ conjointement la création du Réseau d’essais cliniques de l’Atlantique (ACTN) lors du congrès international BIO à San Diego, le plus grand événement mondial en biotechnologie.
Grâce à son agilité et à sa capacité à réunir les bons partenaires au bon moment, l’ACTN crée un point d’entrée unique pour les chercheurs, les partenaires et les patients. Créé par le ministère de la Santé de la Nouvelle-Écosse et codirigé par le IWK Health Centre, Eastern Health, le Réseau de santé Vitalité, le Réseau de santé Horizon et Santé Î.-P.-É., le réseau vise à stimuler la recherche et l’innovation, à offrir de nouvelles possibilités de soins de santé aux habitants de la région et à positionner la région parmi les chefs de file mondiaux en matière d’essais cliniques.
Michelle Thompson, ministre de la Santé et du Mieux-être de la Nouvelle-Écosse, Andrew Furey, Premier ministre de Terre-Neuve-et-Labrador, Dennis King, Premier ministre de l’Île-du-Prince-Édouard, et Dorothy Shepard, ministre de la Santé du Nouveau-Brunswick, étaient présents au congrès pour souligner la valeur de ce partenariat régional en vue d’attirer des investissements dans les essais cliniques au Canada atlantique.
« Nous sommes heureux de nous associer à nos collègues de l’Atlantique pour faire avancer des recherches importantes qui profiteront aux Canadiens de l’Atlantique et aux personnes du monde entier », a déclaré le ministre Thompson. « L’innovation est le moteur de la recherche et permet d’offrir de meilleurs résultats aux patients. Ce partenariat permettra de faire appel aux meilleurs talents, de créer de nouvelles perspectives pour les cliniciens et de proposer des options de traitement de pointe qui pourront potentiellement façonner la pratique clinique nationale, voire mondiale. »
L’approche régionale de l’ACTN offrira l’accès à une population de 2,5 millions de personnes réparties dans quatre provinces, ce qui permettra de tirer parti de certaines données démographiques uniques. La région présente les niveaux de maladies chroniques les plus élevés au Canada, maladies dans certains cas associées à des comorbidités complexes; elle compte l’une des populations les plus âgées du pays; elle comprend de multiples nations fondatrices, qui offrent des données génétiques uniques et présentent une
from L-R Honourable Andrew Furey, Premier of Newfoundland and Labrador, Honourable Denny King, Premier Prince Edward Island, Honourable Dorothy Shephard, Minister of Healthy and Inclusive Communities, New Brunswick, Honourable Michelle Thompson, Minister of Health and Wellness, Nova Scotia / de gauche à droite Honorable Andrew Furey, premier ministre de Terre-Neuve-et-Labrador, honorable Denny King, premier ministre de l’Île-du-Prince-Édouard, honorable Dorothy Shephard, ministre des Communautés saines et inclusives, Nouveau-Brunswick, honorable Michelle Thompson, ministre de la Santé et du Mieux-être, Nouvelle-Écosse.
cutting-edge treatment options that can potentially shape national or global clinical practice.”
The regional approach of ACTN will increase access to a patient population of 2.5 million across four provinces, which will allow for the leveraging of some unique demographics. The region has the highest levels of chronic disease in Canada with complex comorbidities; is home to one of the oldest populations in the country; includes multiple founder populations, which provide unique genetic insights with a high prevalence of rare disease; and has some of the highest rates of autoimmune diseases in Canada.
“We are thrilled to be working with our colleagues in New Brunswick, Newfoundland and Labrador, and Prince Edward Island on this important initiative,” said Dr. Gail Tomblin Murphy, Vice President Research, Innovation and Discovery and Chief Nurse Executive at Nova Scotia Health. “We believe that research is care and caring for our patients is our primary driver. This is a significant opportunity to improve health and health care for those in our region.”
With patient care as the number one priority for ACTN, members of the network recognize that patient engagement throughout the clinical trial lifecycle is essential. That’s why key partners include over 50 patient advisory groups, and patient’s voices are of utmost importance in the design of strategies to optimize patient support services, patient education, communications, and clinical trial design to proactively ensure and improve quality of care.
“Canada’s national biotech ecosystem stretches from coast-to-coast and is built upon a network of vibrant biotech clusters located in every province,” said Andrew Casey, President and CEO of BIOTECanada. “The Atlantic Canada cluster is notably strong with its diverse mix of world-class universities, research institutes, start-ups, small and medium enterprises, and large multinational corporations all connected and supporting a highly skilled workforce. The creation of the Atlantic Clinical Trials Network is another important foundational piece which will further strengthen the region’s biotech ecosystem.
The initiative also represents an important investment by multinational pharmaceutical companies to enhance the environment of discovery and drug development. Ultimately, in addition to the economic value, this investment will support the development of high-value, next generation solutions for patients in Canada and around the world.”
The network has already demonstrated impact through early-stage partnerships with industry and a shared focus on increasing capacity and access to clinical trials while bolstering the economic health investment in the Atlantic region for the benefit of patients. Members are looking forward to working elbow-to-elbow with partners to co-create a research ecosystem that works for all parties involved.
prévalence élevée de maladies rares; enfin, les taux de maladies auto-immunes y sont parmi les plus élevés au Canada.
« Nous sommes ravis de collaborer avec nos collègues du Nouveau-Brunswick, de Terre-Neuve-et-Labrador et de l’Île-du-Prince-Édouard dans le cadre de cet important projet », a déclaré Gail Tomblin Murphy, vice-présidente de la recherche, de l’innovation et de la découverte et infirmière en chef de Santé Nouvelle-Écosse. « Nous pensons que la recherche est en soi une forme de soin, et les soins apportés à nos patients constituent notre principal moteur. Une occasion importante nous est offerte d’améliorer la santé des habitants de notre région et les soins qui leur sont donnés. »
Les soins aux patients sont la priorité numéro un de l’ACTN, mais les membres du réseau ont conscience du fait que la participation des patients tout au long du cycle de vie des essais cliniques est essentielle. C’est pourquoi les partenaires clés comprennent plus de 50 groupes consultatifs de patients. En effet, la voix des patients est de la plus haute importance lors de l’élaboration de stratégies visant à optimiser les services d’aide aux patients, l’éducation des patients, les communications et la conception des essais cliniques en vue de garantir et d’améliorer de manière proactive la qualité des soins.
« L’écosystème biotechnologique national du Canada s’étend d’un océan à l’autre et repose sur un réseau de pôles biotechnologiques dynamiques qui parcourt l’ensemble des provinces », explique Andrew Casey, président et chef de la direction de BIOTECanada. « Le pôle des provinces de l’Atlantique est particulièrement fort grâce à son mélange diversifié d’universités de classe mondiale, d’instituts de recherche, d’entreprises en démarrage, de petites et moyennes entreprises et de grandes sociétés multinationales, tous reliés et faisant appel à une main-d’œuvre hautement qualifiée. La création du Réseau atlantique d’essais cliniques est une autre pièce majeure qui renforcera l’écosystème biotechnologique dans la région.
Le projet représente également un investissement important de la part des multinationales pharmaceutiques pour améliorer l’environnement de la recherchedéveloppement en matière de médicaments. En fin de compte, en plus de la valeur économique, cet investissement favorisera le développement de solutions de nouvelle génération de grande valeur pour les patients du Canada et du monde entier. »
Le réseau a déjà démontré son efficacité grâce à des partenariats avec l’industrie aux premières étapes de développement et à l’établissement d’un objectif commun : accroître la capacité et l’accès aux essais cliniques tout en renforçant l’investissement dans la santé économique de la région de l’Atlantique au profit des patients. Les membres sont ravis de travailler main dans la main avec les partenaires afin de créer avec eux un écosystème de recherche opérationnel pour toutes les parties concernées.
Training Institute Advancing Growth of Burgeoning Canadian Biomanufacturing Industry
THE CANADIAN ADVANCED THERAPIES TRAINING INSTITUTE (CATTI) IS CONTRIBUTING TO THE FAST GROWING biomanufacturing industry in Canada by offering e-learning and onsite programs to help new and existing employees meet exacting skills requirements.
“CATTI’s evolution happened as a response to a pull from the sector,” says Chief Scientific Officer Craig Hasilo, who is based in Montreal. “The number of positions that need to be filled within the various biomanufacturing roles in Canada is substantial - in the order of thousands within even the next five years.”
CATTI provides the excellence required to fill that need for qualified talent and continue growing a Canadian industry that is gaining international recognition for its talents and accomplishments.
Its curriculum has been organized into five themes, covering everything from current Good Manufacturing Practices (cGMP) Foundations, Aseptic Cleanroom Systems, Manufacturing (upstream, downstream and fill-finish), to Quality and Regulatory. Participants can take courses in all five themes if they wish, select predefined learning paths, stack in the individual courses necessary to fulfill their particular career and company needs, or participate in individual courses for career progression and retraining as per GMP requirements.
CATTI provides fit-for-purpose training programs amongst a qualified course list.
“Our overall aim is to deliver people up to specific job role competencies within approximately six weeks of training. It can be any variation of single courses, for example, the Planning for Cell Therapy Clinical Trial Applications course that we’ve recently launched,” explains Hasilo.
“We offer hands-on practicum to deliver not just the theory, but the practical skill sets that people will require to be able to excel in this work environment, and to be as prepared as possible for what they may encounter when they reach the job site,” he elaborates.
“The CATTI courses provide candidates with a safe space to practice, develop and hone their skill sets under a lens of industry best practices so that when they get to the workforce they are the most qualified that they could possibly be,” Hasilo adds.
“The programs that we have can be considered best in class. They have been carefully reviewed by a committee of cell and gene therapy experts who work in this field,” says Andre Mumme, CATTI’s Montreal-based Director of Business Development and Partnerships.
The company’s education committee consists of 18 subject matter experts, who are responsible for complying with cGMP requirements and training their staff forces. They help review the curriculum, iron out any wrinkles, and determine if there are any gaps in training opportunities that need to be further developed.
CATTI, which was officially incorporated in 2021, has offices in Montreal and Toronto, as well as a practical, CL2 lab-based, training centre for specialized hands-on training at the University of Guelph, about an hour’s drive west of Toronto. This enables CATTI the capacity to focus on providing participants skills development in both GMP and CGT-specific skills in manufacturing stem cells, T-cells, MSCs and viral vector production. Participants will undergo skills verifications through program assessments and online examination to ensure competency requirements have been met.
“Participants can expect to learn best practices in CGT (Cell and Gene Therapy) manufacturing from expert instructors that have been on the front line, that have helped initialize new facilities, trained their staff forces and have worked directly on production. We have outstanding trainers,” notes Hasilo, who adds that subject
matter experts know exactly what it takes to produce the therapeutics, and to deliver safe products to patients.
CATTI is led by a consortium of two highly successful Networks of Centers of Excellence in Canada – the Center for the Commercialization of Regenerative Medicine [CCRM] and CellCAN Regenerative Medicine and Cell Therapy Network, which is a knowledge mobilization company. This provides a unique opportunity for CATTI to leverage the strengths and synergies of both organizations to contribute substantially to growing the cell and gene therapy sector in Canada.
“It’s an opportunity to learn from experience. Our combined network of CellCAN and CCRM is in the hundreds of global experts. We have a very niche specific set of experts to tap into,” Hasilo stresses.
“CATTI is new but as CellCAN and CCRM we’ve trained hundreds of people for the better part of at least half a decade now. The programs have been successful and
BENEFITS TO TRAINEES: Work ready qualifications, GMP cleanroom workflow exposure, gain experience on new technologies, gain an understanding of manufacturing and quality requirements for CGT production, and industry recognized certification of practical skills in high demand.
BENEFITS TO EMPLOYERS: Fast track training with no risk to production environments, decrease time to generate productive and autonomous HQP, reduce the strain on staff resources for training, expose HQP to new technologies prior to adopting them into process workflows, and standardize the base skillset of your labour force they’ve been internationally recognized. Now they’re becoming more and more impactful and appropriate for the sector under the umbrella of CATTI,” he adds.
CATTI is also working with universities and bio-hubs across Canada to meet customer needs. At universities, for example, graduate and postgraduate students will be exposed to the CATTI training curriculum. This knowledge will be required to work in this field and will enable future employees to be job ready for the biomanufacturing marketplace, Mumme explains.
“Within Canada, there are some pockets of fantastic expertise, whether it be cancer immunotherapies or gene therapy, that are working on tools that help to edit and correct the problems that might exist in peoples’ genomes to alleviate the burden of disease from medications,” says Hasilo.
With a renewed focus on both rare diseases and diseases that more broadly affect more of the population, such as cardiac disease and diabetes, there is a tremendous need for greater talent development to help produce these therapeutics. As new therapeutics are introduced, especially those that are life-saving or lifealtering, patients are able to access them faster, says Hasilo.
For example, the COVID-19 pandemic brought forth a whole new focus on nucleic acid manufacturing for mRNA vaccine potential, and it is expected there will be a host of other types of therapies impacted by that same type of technology.
“We’re seeing a bubbling of the ecosystem. We’re seeing companies pop up in support of many of these manufacturing sites. So it’s a very exciting time for our niche,” Hasilo emphasizes.
catti.ca
History. Expertise. Transformation:
Manitoba –A Centre for Ag Biotech
MANITOBA IS NOT ONLY THE CENTRE OF CANADIAN CROP PRODUCTION BUT IS THE CENTRE FOR AGRICULTURAL BIOTECHNOLOGY (ag biotech) innovation. Researchers and industry are contributing to the advancement of crop productivity production enhancement and improving food security at global level.
The Manitoba ag biotech sector revenues were 5.36 billion in 2021 with over 360 companies currently here. Agritech or Ag biotech is the fastest growing industry in Manitoba and it is projected to have over 700 new jobs in the next 3 years and currently employs 8500 people, researchers and scientists. As an industry association, the Bioscience Association Manitoba (BAM) is an ardent advocate for ag biotech. Since it’s inception, BAM has been a trusted resource and connector focusing on enabling the success of our members in the areas of plant genomics, precision agriculture, health treatments for animals, and health food and ingredients. These sectors offer new business opportunities that enable our entrepreneurs to think about creating disruptive businesses and new innovative technologies.
XITEBIO
Based in Winnipeg, XiteBio is an agriculture company engaged in crop inputs and agriculture supplements for Canadian, American, European, and South American markets. XiteBio Technologies is creating innovative, cost-competitive, eco-friendly liquid inoculant product lines that improve crop health of their crops leading to better yields. MSPREBIOTIC AND SOLNUL
MSP Starch Products Inc. (MSP) offers Solnul, a proprietary prebiotic resistant starch produced through the upcycling of aqueous raw material from potato manufacturing. It is the first Canadian company to receive certification for Solnul from UpcycledFood.org, an NGO focused on reducing food waste. Dietary supplement and food companies that incorporate ca. 10% of Solnul can use a front of pack logo “Upcycled Certified” to inform consumers of their efforts in environmental sustainability and is a great example of the circular economy at work in Manitoba!
PRAIRIE FAVA
Prairie Fava (PF) was established in 2014 in Glenboro Manitoba, as a manufacturer focused only on fava as a whole food ingredient supplying whole bean, dehulled splits, raw and precooked flour, flakes and grits. PF is integrated and specialized in the commercial production, selling, and marketing of fava bean food ingredients offering complete traceability and control from seed to end product, In 2020, PF partnered with Roquette LLC in a large Protein Industries Canada funded project focused on technology development and commercialization of high-quality plant protein ingredients and consumer products from fava.
CONVIRON
Conviron is a global leader in precision reach-in plant growth chambers, walk-in rooms and custom controlled environments for plant research, cannabis production and plant-derived pharmaceutical applications. Founded in 1964, they are the only manufacturer singularly focused on the technology and science of plant growth in controlled environments. Conviron has developed specialized expertise and understanding in plant responses to controlled environmental factors. They are the most highly cited plant growth chamber and room manufacturer in thousands of peer reviewed academic publications around the world.
KGS GROUP
The effects of climate change, coupled with the rising costs of land, machinery, fuel, pesticides and fertilizers, have agricultural producers looking for alternative, innovative solutions to increase yields. Bio-inoculants, natural micro-organisms applied to soil or plants to improve soil health, may be one such solution. KGS Group in collaboration with University of Manitoba researchers have developed two bio-inoculant strains, KGS-2 and KGS-3, to help farmers tackle the many challenges they face today in an environmentally friendly way.
Manitoba has a long history of enabling the ag biotech industry to fully realize value-added applications for their crops and livestock. The development of consumer ready products especially in food and health, can bring significant economic returns and improved incomes for primary producers. Manitoba is home to 24 world class agrifood research and development center that work in parallel to support farm to fork innovations.
THE FOOD DEVELOPMENT CENTRE
With over thirty years of expertise, the Food Development Centre (FDC) excels in food research combining product commercialization with technical and research assistance for agri-food businesses, with a service focus on plant and animal protein products and ingredients. FDC offers laboratory trials to commercial readiness of food product prototypes and food ingredients. RICHARDSON CENTRE FOR FOOD TECHNOLOGY AND RESEARCH
As part of the University of Manitoba, the RCFTR is an important research partner in the ag biotech cluster. The Centre is available to the agri-food, natural health product, and pharmaceutical industries to determine structure, function, efficacy, and safety through controlled animal and human studies. A unique Pilot Plant supports the manufacturing process from prototype through to commercial scale-up including capabilities for the extraction of bio-actives from plant material or food products.
PRAIRIE RESEARCH KITCHEN, RED RIVER COLLEGE POLYTECH
The commercialization of agri-food depends not only on supply of raw materials which are in abundance in Manitoba, but on taste and appearance of the final consumer ready product. The Prairie Research Kitchen (PRK) is the leading Culinary Research & Innovation program in Western Canada devoted to combining food science with culinary arts to develop incredible products. Located at Red River College’s School of Hospitality and Culinary Arts, PRK has access to five modern kitchens and bake labs, two restaurants, and a mixology lab.
WHY MANITOBA?
Traditionally known as the gateway to the West, Manitoba is quickly becoming the Gateway to the World.
Manitoba’s bioscience industry, while gaining strength and momentum, will continue to drive the bioeconomy to the next level through collaborations and partnerships across the country and around the world.
Steady as a strategic marathon runner, Ceapro is winning the race.
As they Celebrate 25 years, Edmonton-based Ceapro Inc. is a rapidly ascending star in biotech, outperforming the market with its disruptive technologies and naturally sourced bio-actives for cosmeceuticals, nutraceuticals, and pharmaceuticals.
IN AN AGE OF SOARING APPETITES FOR NATURALLY SOURCED, ORGANIC, AND VEGAN PRODUCTS, “FUNCTIONAL” FOODS AND BEVERAGES, and green/carbonneutral technologies, Edmonton – based biotech Ceapro Inc. is well positioned to deliver. Ceapro (which stands for CEreal Advanced PROcessing) develops proprietary extraction and processing technologies, and applies these technologies to produce potent, naturally sourced bio-actives and unique complexes from renewable plant resources.
While you may not have heard the name Ceapro, there is a high likelihood that you use brands containing the Company’s active ingredients; Aveeno, Neutrogena, Dove, Lubriderm, The Body Shop, Burt’s Bees, Nexcare, Philosophie, Gilles Gagnon, CEAPRO CEO Jergens, and Roc to name a few. Founded in 1997, Ceapro’s thriving base business selling their active ingredients into the personal care and cosmeceutical markets has generated steady growth, fuelled by their top two value drivers: oat beta glucan and avenanthramides (powerful anti-inflammatories and antioxidants extracted from oats using the company’s proprietary extraction technologies.) After successfully managing through some challenging years, the company is now in an enviable position. In a market where investment in biotech is slowing, Ceapro is thriving. While many are unfortunately sitting at historical lows, Ceapro’s stock hit a fifty-two - week high this month, after seeing its growth rate triple over the last 18 months, and with a
steady flow of positive news regarding research partnerships, positive study results, and plans to expand into new markets. Profit margins also jumped by an impressive 50% over the last year, largely due to efficiencies achieved in production, and a growing appetite for Ceapro’s flagship value driver; avenanthramides. With zero debt, one of the healthiest balance sheets in the industry, and multiple assets in development with a staggering number of potential therapeutic applications, Ceapro is poised for an explosion in potential growth fueled by out-licensing of their proprietary technologies and the plethora of innovative products they have enabled.
When seasoned pharma executive Gilles Gagnon became CEO in 2012, he focused the company on marketing two key value drivers, exclusively to the cosmetic and personal care product industries, while setting in motion a ten-year plan to develop their broader potential applications in healthcare. Ten years later, a profitable base business has successfully fueled a steady stream of re-investment into research and development of these same active ingredients for nutraceutical and pharmaceutical applications, as well as the application of their disruptive proprietary Pressurized Gas Expanded Technology (PGX) toward the development of new therapeutic candidates. “After seeing strong consistent growth of our thriving base cosmeceutical business over the last 10 years, 2021 was our best year on record, and based on the first half results for 2022 and our strong pipeline, this trend is likely to continue to
accelerate.” Gilles Gagnon
The market for oat beta glucan and avenanthramides is growing rapidly and remains largely untapped. Based on their powerful antioxidant and anti-inflammatory properties and very favorable safety profiles, both have a staggering number of clinical and nutritional applications across multiple therapeutic areas, most notably cardiovascular and respiratory medicine, a myriad of inflammatory diseases, oncology, and dermatology (everything from anti-aging to wound healing).
These applications are supported by development programs and results from multiple studies in collaboration with institutions including the University of Alberta, the Montreal Heart Institute, the University of Minnesota, and Boston - based Angiogenesis Foundation. “As we celebrate our 25th anniversary, we haven’t even scratched the surface yet, with an abundance of opportunity on the horizon. Because of our very strong financial position we are ready to leverage our multiple assets in development and transform our business model from a manufacturer of bio-active ingredients in cosmeceuticals to a global life sciences company.” says Gagnon.
After demonstrating the efficacy of their avenanthramides formulation in reducing inflammatory markers in exercise-induced inflammation through a research collaboration with the University of Minnesota, the company expects a response for clearance from Health Canada to initiate a Phase 1 study with a Phase 2 extension in collaboration with the Montreal Heart Institute to establish the safety, tolerability, and efficacy of a 30 mg and 240 mg dose of purified avenanthramides to
treat mild inflammation observed in conditions like metabolic syndrome. The Company also entered a research collaboration in 2021 with the Angiogenesis Foundation to characterize the in vivo bioactivity of Ceapro’s oat beta glucan and avenanthramides on angiogenesis, blood vessel repair, wound healing, and tissue regeneration.
While the opportunity to grow the company’s core value drivers is substantial, Ceapro’s biggest growth potential may lie in the application of its patented disruptive technology, PGX. “Over the last 10 years we have methodically executed the strategy of using proceeds from our base business to fuel our eventual expansion into new markets. At the end of the day we not only succeeded, but also discovered a technology along the way that may represent the biggest commercial opportunity for us.” (Gilles Gagnon)
PGX is a disruptive new “green” technology that promises to be a game-changer in drug and bioactive processing and delivery. Addressing a myriad of unmet needs and issues that nutraceutical and pharmaceutical manufacturers grapple with, PGX may make much of what was previously impossible with conventional processing and drying methods possible. “PGX processing will be of interest to manufacturers looking to increase bioavailability and efficacy, reduce processing steps and carbon footprint, eliminate unwanted ingredients or additives from their formulations, increase stability and shelf life, and/or offer new and innovative delivery systems beyond pills and capsules.” says Gagnon.
PGX is a process that instantly dries naturally sourced polymers (like beta-glucans, starches or polysaccharides) into ultralight, highly porous fine powders, granules, or microfibrils that can be uniformly “impregnated” with one or more bio-actives. The process reduces particle size to previously unachievable levels while simultaneously dramatically increasing the available surface area by up to 100 times, potentially increasing bioavailability where far less active drug could be used to produce the same (or greater) therapeutic effect.
Invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta, along with Dr. Bernhard Seifried, now Senior Director of Research and Technology at Ceapro, PGX simultaneously addresses multiple issues that have historically presented significant challenges for drug and nutraceutical manufacturers. “The large specific surface area and unique fibrous morphology make PGX-processed polymers ideal carriers for bioactive compounds or to improve dispersion of hydrophobic materials in an aqueous system. PGX-processed compounds are instantly dissolved and remain evenly dispersed and stable in water, while being essentially free of unwanted odors, colors, flavours or impurities. PGX Technology eliminates the need for toxic solvents or high-heat processing that would otherwise destroy or denature heat-sensitive actives and reduces or eliminates the need for additional processing steps or added ingredients like emulsifiers, stabilizers, preservatives, or bleaching agents. In the same single step, the PGX process also purifies and extends shelf life, and the ability to make even hydrophobic ingredients instantly dispersible in water means transport costs can often be cut significantly for manufacturers as well” says Seifried.
One of the most exciting aspects of PGX is that it could make new delivery systems possible for many drugs or bio-actives that would otherwise need to be delivered as pills or capsules swallowed with water, or delivered intravenously, enabling delivery through inhalation, nasal delivery, or delivery via small alginate thin strips that either instantly dissolve on the tongue or can be applied topically. For example, alginate thin strips can be impregnated with multiple drugs or bio-actives, requiring only a small amount of drug to produce the therapeutic effect. Additionally, the strips are tunable for rapid action or slow release of drug. “This is a significant advantage in terms of compliance. Picture a future where, instead of having to dispense and swallow multiple pills, a senior or
child could be given a single dissolvable strip that instantly dissolves on the tongue or skin. Strips with different bio-actives or drugs can also be layered into one easydissolve strip, and no water for swallowing is required”.
Ceapro has exclusive worldwide rights to market and license PGX processed products across all industrial applications. Presented at multiple conferences worldwide, including the recent 2022 Supercritical Fluids Conference in Montreal, PGX has generated interest across multiple industries. Since licensing from the University of Alberta, the company has leveraged the discovery of PGX toward the development of several innovative therapeutic candidates and products, in collaboration with multiple academic institutions, generating several scientific articles published in peerreviewed journals.
One such partnership is an ongoing research collaboration with McMaster University to develop an inhalable immuno-therapeutic/-prophylactic for COVID-19-induced lung fibrosis. This builds on a larger research collaboration initiated in 2019 aimed at developing innovative drug delivery systems using the PGX technology to optimize drug formulations for areas of high unmet medical needs such as idiopathic lung fibrosis and antibiotic-resistant infections. Due to the tiny particle size PGX can generate, the natural polymers also act as carriers that can deliver active drug deep into tissues that were previously unreachable, like fibrotic tissues deep in the lung. To date, PGX technology has demonstrated the ability to purify and dry yeast beta glucan (YBG) into uniform inhalable particles that can modulate the immune system through a specific mechanism of action. Findings are under peer review and expected to lead to a Phase 1 trial of YBG as an inhaled therapeutic.
One of the first PGX-powered products to reach the market may be functional beverage formulations for nutraceutical applications, including energy and immuneboosting drinks. PGX’s nutraceutical applications are the result of a three-year collaborative project with the University of Alberta aimed at investigating the potential of PGX-processed polymers like yeast beta-glucan and alginate to act as delivery systems to increase the bioavailability of bio-actives like natural energy booster Coenzyme Q10. This research collaboration has generated a wealth of publications and presentations at international scientific conferences. Findings from these studies illustrate the untold potential of the PGX Technology in generating the next generation of products enabling Ceapro to expand into a high-end Life Science company,” commented Gagnon. “While avenanthramides is the asset that drew me to the company years ago, PGX is a game changer. It is a revolutionary platform that could result in the launch of many transformative products that otherwise would not have been possible. Ten years ago, we made the decision to invest in developing this technology, and it has proved to be a pivotal decision. We took a methodical, cautious, stepwise approach in scaling up the technology to avoid common mistakes made when trying to skip steps in a process. We are now ready to out-license applications coming from the use of the technology, and multiple companies have already expressed interest. We took our time to ensure we did not shortchange the process, and now it is ready to pay off.” To support their impending expansion into new markets, Ceapro recently added two seasoned pharma executives to their distinguished board of directors; newly appointed Board Chair Mr. Ronnie Miller who served as CEO of Roche Canada from 2000 to 2022, and Ms. Genevieve Foster, a corporate lawyer with extensive experience in the healthcare sector. Other Board Members include Dr. William Li ( world-renowned physician, scientist, and speaker, New York Times best-selling author, and President, and Co-founder of the Boston-based Angiogenesis Foundation), Dr. Ulrich Kosciessa PH.D. (CEO of Germany-based Photonamic GmbH & Co. KG, and COO of Tokyo – based SBI Pharma), and Mr. Glenn Rourke (former Vice President World Corporate banking at BMO). The Executive Team is also being expanded, with the addition of Sigrun Watson as Chief Revenue officer who will lead the growth strategy, and the expansion into nutraceutical and pharmaceutical markets.
For more information on Ceapro, please visit the Company’s website at www.ceapro.com. (Ceapro trades under the TSX Venture Exchange under “CZO” and on the OTCQX Best Market under “CRPOF”).