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FEDERAL PERSPECTIVE LE POINT DE VUE FÉDÉRAL An ambitious plan for Canada’s Biotech Industry
An ambitious plan for Canada’s biotech industry Un plan ambitieux pour l’industrie canadienne de la biotechnologie
by the Honourable François-Philippe Champagne, P.C., M.P. Minister of Innovation, Science and Industry par l’honorable François-Philippe Champagne, C.P., député Ministre de l’innovation, des Sciences et de l’Industrie
MOST CANADIANS KNOW ABOUT THE IMPORTANT ROLE CANADA PLAYED IN THE DISCOVERY OF INSULIN, A LIFE-SAVING DISCOVERY that has improved the lives of countless diabetics around the world. But many are not aware that Canadian scientists have also been instrumental in discoveries related to the polio and Ebola vaccines, or that it was in a Canadian lab that a compound was developed to stunt HIV’s vicious rate of replication. These innovations have literally saved millions of lives globally and are examples of the life-saving work being done right here at home.
When the COVID-19 pandemic began, our government knew the answer to solve this global challenge was through science. That’s why we acted quickly to make major investments to build up the sector and to help Canadians cope with the pandemic. Our government’s response was focused not only on the short-term strategic solutions but also on developing a long-term vision for Canada’s recovery.
Thanks to these early investments to fight the pandemic, we are helping homegrown firms like AbCellera, BIOVECTRA and Medicago, and many others, across the country grow. Our goal it to reinforce the overall strength of our domestic sector. To date, we have supported 29 Canadian COVID-19 biomanufacturing, vaccines and therapeutics projects through the Strategic Innovation Fund, Next Generation Manufacturing Canada, the National Research Council of Canada, and many other government agencies and partners.1
As the minister responsible for innovation, science, and industry, and as the former minister for foreign affairs, I am proud to see that by supporting the long-term resilience of our domestic biomanufacturing capacity, we have also attracted the attention of the world. We have seen global firms like Moderna, Sanofi and Merck initiate new operations here.
NOUS CONNAISSONS BIEN LE RÔLE IMPORTANT QUE LE CANADA A JOUÉ DANS LA DÉCOUVERTE DE L’INSULINE, qui améliore la vie d’innombrables diabétiques dans le monde. Cependant, peu savent que des scientifiques canadiens ont joué un rôle crucial dans des découvertes liées aux vaccins contre la poliomyélite et la maladie à virus Ebola, et que c’est dans un laboratoire canadien qu’a été mise au point une substance qui ralentit la réplication du VIH. Ces innovations ont sauvé des millions de vies et sont des exemples du travail salutaire qui s’effectue dans notre pays.
Dès l’éclosion de la pandémie, le gouvernement a misé sur la science pour contrer ce fléau mondial. Nous avons dégagé des sommes importantes pour reconstruire le secteur de la biofabrication et des sciences de la vie et aider les Canadiens à traverser la crise. Nous avons mis l’accent sur des solutions stratégiques et immédiates conjuguées avec une vision à long terme pour assurer une reprise économique prospère et durable.
Nos investissements pour lutter contre la pandémie ont aidé et aident encore des entreprises canadiennes comme AbCellera, BIOVECTRA et Medicago, et bien d’autres encore, à prendre de l’expansion. Notre objectif est de renforcer le secteur dans son ensemble. À ce jour, nous avons annoncé 30 projets dans l’écosystème de la biofabrication, des vaccins et des thérapies, renforçant les capacités nationales d’intervention en cas de pandémie et innovation en sciences de la vie par l’entremise du Fonds stratégique pour l’innovation, de Next Generation Manufacturing Canada, du Conseil national de recherches Canada et de nombreux autres partenaires des secteurs public et privé1 . À titre de ministre de l’Innovation, des Sciences et de l’Industrie et d’ancien ministre des Affaires étrangères, je suis fier de voir que les mesures pour assurer la résilience à long terme de la capacité nationale de biofabrication ont attiré l’attention du monde entier. Des multinationales comme Moderna, Sanofi et
When the COVID-19 pandemic began, our government knew the answer to solve this global challenge was through science. That’s why we acted quickly to make major investments to build up the sector and to help Canadians cope with the pandemic. Our government’s response was focused not only on the short-term strategic solutions but also on developing a long-term vision for Canada’s recovery.
They have made these decisions because they understand the many advantages of partnering with Canada. Whether its our numerous trade deals, our preferential access to markets and global supply chains, or our highly educated and competitively skilled population, we have what’s needed to attract both talent and investments to Canada. We are a country that values stability, predictability and the rule of law. And in these unprecedented times, it is clear that these values will guide not only the immediate investments and innovations we’re seeing but also the long-term growth and resilience of our country’s future.
As we look to a post-pandemic future for Canada, there is no doubt that we must supercharge the amazing potential we’ve seen in this key economic sector. To guide us in this endeavour, we look to our leading scientists, researchers, industry experts, and key stakeholders, in order to develop Canada’s Biomanufacturing and Life Sciences Strategy. This cross-government effort will help ensure that businesses, scientists, researchers and post-secondary institutions have the tools and resources they need to advance future discoveries of vaccines and therapeutics, and that we can grow the domestic talent needed to support our ambitious objectives.
In support of the strategy, the 2021 federal budget devoted more than $2 billion to growing our biomanufacturing and life sciences sector. This funding included $500 million for the Canada Foundation for Innovation to support the bioscience capital and research
Merck ont entrepris de nouvelles activités dans notre pays parce qu’elles savent que le Canada a toutes les ressources pour être un partenaire de choix. De nombreux accords commerciaux, un accès privilégié aux marchés et aux chaînes d’approvisionnement mondiales, une population très instruite et compétente; nous possédons tous les atouts pour attirer les talents et les investissements. Notre pays valorise la stabilité, la prévisibilité et la primauté du droit. En ces temps sans précédent, il est clair que ces valeurs orientent les décisions d’ investissements et d’innovations, de même que celles relatives à la croissance à long terme et à la résilience de notre pays.
L’avenir postpandémique se dessine. Nous avons une occasion de stimuler le potentiel phénoménal de ce secteur économique clé, et nous comptons sur nos plus éminents scientifiques, chercheurs, experts de l’industrie et intervenants clés pour mettre en œuvre la Stratégie en matière de biofabrication et de sciences de la vie. Ce travail pangouvernemental nous permettra de veiller à ce que les entreprises, les scientifiques, les chercheurs et les établissements postsecondaires disposent des outils et des ressources dont ils ont besoin pour faire avancer la recherche sur les vaccins et les thérapies. Il nous permettra également de former un bassin d’experts pour soutenir nos ambitieux objectifs.
En appui à la Stratégie, le budget fédéral de 2021 prévoit plus de 2 milliards de dollars pour la croissance du secteur de la biofabrication et des sciences de la vie. Ce financement comprend 500 millions de dollars pour la Fondation canadienne pour l’innovation. La Fondation répondra ainsi aux besoins en capital et en infrastructure de recherche en sciences biologiques des établissements postsecondaires et
Dès l’éclosion de la pandémie, le gouvernement a misé sur la science pour contrer ce fléau mondial. Nous avons dégagé des sommes importantes pour reconstruire le secteur de la biofabrication et des sciences de la vie et aider les Canadiens à traverser la crise. Nous avons mis l’accent sur des solutions stratégiques et immédiates conjuguées avec une vision à long terme pour assurer une reprise économique prospère et durable.
infrastructure needs of post-secondary institutions and research hospitals across the country. These major investments will also create a new tri-council biomedical research fund; support company creation, scale-up and training activities in the life sciences sector; increase clinical research capacity through a new Canadian Institutes of Health Research clinical trials fund; support stem cell and regenerative medicine research; and further invest in the Vaccine and Infectious Disease Organization to support the development of its vaccine candidates and expand its facility in Saskatoon.
This is all critical groundwork for Canada. These investments will not only help see us through the COVID19 pandemic and address possible future health crises, but they’ll also help to consolidate our long-term approach to Canadian healthcare in areas such as cancer research and various other chronic diseases. That’s why we will continue to support the growth of our domestic life sciences firms. Because it means more life-saving breakthroughs. It means thousands of new well-paying and highly-skilled jobs. And it means a future where Canada is a world leader in preventing, treating and curing all kinds of illness and disease.
As Canada continues to battle COVID-19, we should allow ourselves to be inspired by a few truths that have come to light during the course of this pandemic: first, Canadians are capable of great things when we work together; second, our world-class science and research enterprises deliver innovations that help the world weather tough times; and third, the biomanufacturing and life sciences sector can count on our government’s support in whatever comes next.
des hôpitaux de recherche partout au pays. Cette enveloppe permettra également de créer un nouveau fonds de recherche biomédicale administré par les trois conseils subventionnaires; de soutenir la création d’entreprises et leur expansion; et d’effectuer de la formation dans le secteur des sciences de la vie. En outre, ces sommes serviront à accroître la capacité de recherche clinique grâce à un fonds pour les essais cliniques des Instituts de recherche en santé du Canada; à appuyer la recherche sur les cellules souches et sur la médecine régénératrice; et à investir davantage dans la Vaccine and Infectious Disease Organization pour soutenir la mise au point de ses vaccins candidats et agrandir ses installations à Saskatoon.
Il s’agit d’un travail préparatoire essentiel pour le Canada. Ces investissements nous aideront, non seulement à traverser la pandémie de COVID-19 et à affronter de futures crises sanitaires, mais aussi à consolider notre approche à long terme à l’égard du système de santé dans le domaine de la recherche sur le cancer et sur diverses autres maladies chroniques. Nous continuerons de soutenir la croissance des entreprises canadiennes dans le domaine des sciences de la vie qui réalisent des percées susceptibles de sauver des vies et qui créent des milliers d’emplois hautement spécialisés et bien rémunérés. Nous positionnons le Canada comme chef de file mondial dans le domaine de la prévention, du traitement et de la guérison de toutes sortes de maladies.
La lutte contre la COVID-19 n’est pas terminée. Nous pouvons toutefois en tirer quelques constats: les Canadiens sont capables de grandes choses lorsqu’ils travaillent ensemble; nos scientifiques et chercheurs de calibre mondial continueront d’innover pour aider le Canada et le monde à passer au travers de cette période difficile; et le secteur de la biofabrication et des sciences de la vie pourra continuer à compter sur le gouvernement fédéral pour le soutenir, peu importe ce que nous réserve l’avenir.
Cell and Gene Therapy in Canada:
Leading Companies and the Commercial Opportunity
By Kyle O’Neil and Brendan Wang, Back Bay Life Science Advisors
AS INDUSTRY TRENDS CONTINUE TO POINT TOWARDS INCREASED CONSOLIDATOR INTEREST, THE CANADIAN cell and gene sector is advancing technology and moving towards commercialization. Back Bay Life Science Advisors shares which Canadian companies are progressing technology in the sector and offers a perspective of the inherent nuances of Canada’s unique market dynamics and public health insurance system. “Overview of selected Canadian cell and gene therapy biotech companies” – figure available upon request at www.bblsa.com
THEME #1: CRISPR 2.0
Intellia’s in vivo proof-of-concept CRISPR data from NTLA-2001 in six patients with hereditary transthyretin amyloidosis (hATTR) has spurred extensive investor interest in improved editing technologies (1). Potential improvements to CRISPR/Cas9 aim to overcome limitations such as: 1. Restrictions to specific protospacer adjacent motifs (PAMs), a short DNA sequence (usually 2-6 base pairs) where CRISPR binds to perform its editing function 2. Delivery, which often limits the applicability of CRISPR platforms such as Intellia’s to the liver, where most molecules traffic
Quebec-based Feldan Therapeutics raised ~$16M and published multiple papers on a system of amphiphilic peptides called the “Feldan Shuttle” for CRISPR delivery (2, 3), which potentially addresses one of the key challenges of delivery for DNA editing approaches. The “Shuttle” is a short peptide that circumvents delivery challenges by avoiding endosomal entrapment and can be applied to multiple therapeutic modalities.
THEME #2: CELL THERAPY 2.0
With five launched autologous CAR-T therapies targeting CD19 and BCMA rapidly surpassing $1B in total sales, a variety of platform technologies have been advanced to address the limitations of autologous therapies including: 1. Long manufacturing time that limits their utility for rapidly progressing tumors 2. Safety concerns such as cytokine release syndrome (CRS)
Canadian biotech companies such as Notch Therapeutics are advancing platforms ranging from induced pluripotent stem cell (iPSC) engineered CAR-Ts to innate immune cells and even in vivo engineered CAR-Ts. Given Notch has raised ~$90M to date, the company may look beyond immunooncology with its listed pipeline programs in Tregs, which have potential across a range of autoimmune and ocular indications and other immune cell types.
THEME #3: INTEGRATED MANUFACTURING COMPANIES
There is an increasing number of therapeutic companies in the cell and gene therapy space formed at inception with manufacturing capabilities. Recently launched companies developing the integrated product and platform business model include Forge Biologics, Resilience, and ElevateBio, who have collectively raised over $1.5B since mid-2019. Similarly, companies with manufacturing capabilities such as Codexis and Oxford BioMedica are leveraging their manufacturing capabilities to increasingly branch into more “high-risk, high-reward” therapeutics development. Since the cost of goods sold (COGS) for cell and gene therapies is higher than other therapeutic modalities (~40%) and manufacturing times for components such as viral vectors are long, there are significant manufacturing constraints (4).
This trend is perhaps more important for early-stage companies, who should consider manufacturing in their exit planning and company growth model. In Canada, companies such as the Centre for Commercialization of Regenerative Medicine (CCRM) are ideal manufacturing partners throughout the product lifecycle. Companies may also opt to build their manufacturing system in-house; one such example is Avrobio, which was founded based on work from two Canadian scientists through CCRM’s incubator arm and has developed a proprietary plato® platform that includes manufacturing technology. Also notable is Canada’s recent $164M investment in Resilience to expand a biomanufacturing site in Ontario.
THEME #4: LARGE MARKET C>
Due to the limited whitespace and commercial challenges in rare indications on the backdrop of a cash-strapped market environment, gene therapy
companies are also exploring non-orphan opportunities. There are several different non-orphan indications under exploration including CNS diseases (e.g., Eli Lilly’s PD-GBA in Parkinson’s disease), autoimmune diseases (e.g., Orchard Therapeutics’ OTL-104 in Crohn’s disease) and cardiovascular diseases (e.g., Tenaya Therapeutics’ DWORF in dilated cardiomyopathy). Unlocking these larger indications will be critical for gene therapy companies to deliver value to investors, which is likely to require substantial differentiation from the standard of care, as existing therapies are available at prices much lower than traditional gene and cell therapies.
Canadian company BlueRock Therapeutics, acquired by founding investor Bayer in 2019 and valued at up to $1B, has a proprietary induced pluripotent stem cell (iPSC) platform. BlueRock’s lead program in Parkinson’s disease is aimed at delivering the lost dopaminergic neurons in the substantia nigra and dosed its first patient in Canada in January 2022, with further applications of its platform expected to be used in cardiology, immunology and ophthalmology.
COMMERCIALIZING CELL AND GENE THERAPIES IN CANADA
Key to ensuring that innovative cell and gene therapies make it from the lab to patients is an understanding of the pathway to commercialization within the Canadian market, which has a vastly different healthcare ecosystem compared to the US. Canada’s universal public health insurance system ensures access to medically necessary physician visits, diagnostics and hospital stays (5). However, prescription drugs fall outside of this structure and are covered on a provincial and territorial level. While the federal government provides some funding to provinces, it is up to the individual provinces and territories to make reimbursement decisions. Patients may additionally opt into private insurance for supplemental prescription drug coverage, either individually or through an employer (6).
There are several stakeholders relevant to commercializing a cell or gene therapy including at the provincial/territorial and national level. At the provincial and territorial level, provincial-level payers manage their own budgets and decide whether and for whom they will reimburse a new product. Additionally, multiple provinces can band together to negotiate prices with manufacturers through the Pan-Canadian Pharmaceutical Alliance (pCPA). National-level stakeholders include the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Patented Medicine Prices Review Board (PMPRB). The CADTH serves as Canada’s HTA authority and evaluates new therapies, making a national, non-binding recommendation on how novel therapies should be utilized and whether they should be reimbursed. Nonetheless, each individual province/territory ultimately decides whether to reimburse a particular product. The PMPRB sets ceiling prices for drugs based on international reference pricing (IRP) and a variety of other factors. Recent reforms (7) have the potential to change several elements of the PMPRB’s price ceiling calculations by allowing them to drop higher cost markets (e.g., US) from the reference basket, thus lowering the price ceiling and enabling consideration of cost-effectiveness of new therapies and their potential impact to government budgets, further making early consideration of potential Canadian market access issues critical for early-stage companies.
Article references available upon request: info@bblsa.com
ABOUT BACK BAY LIFE SCIENCE ADVISORS
Back Bay Life Science Advisors is top-ranked life sciences consultancy specializing in biopharma and medtech development. We provide life science companies across all stages and sectors with strategic development and investment banking expertise and execution across a wide range of therapeutic areas including cancer, inflammation, vaccines, rare disease, neurology and cell and gene therapy development.
EXPERTS IN CELL & GENE THERAPY DEVELOPMENT
Back Bay has a special and nuanced understanding of the scientific, clinical and commercial positioning of novel cell and gene therapy technologies across the product life cycle, including preclinical and clinical development, product launch and manufacturing. Our cell and gene therapy expertise spans established therapeutic areas, such as oncology and technologies, such as gene editing, and novel therapies.
At Back Bay Life Science Advisors, we analyze technologies to inform development strategies and determine the best path forward for commercial success and the betterment of human health.
Contact the Back Bay team in Boston, Toronto, or Europe to learn more about our cell and gene therapy projects.
www.bblsa.com
Fonds de solidarité FTQ —
Let’s Support Creativity in Developing New Businesses encourageons la créativité dans la création d’entreprises
by/par Geneviève Guertin, Vice-présidente Placements privés et investissement d’impact | Sciences de la vie/ Vice-President Private Equity and Impact Investing | Life Sciences
DEVELOPING NEW BUSINESSES IS A PRIMARY AREA OF INTEREST FOR INVESTORS LIKE THE FONDS, both as a source of companies to build our portfolio and from an economic standpoint, as they contribute to producing collective wealth.
The life sciences are a vibrant sector that builds highpotential businesses, generates many high-quality jobs, and contributes to the province’s GDP, all while developing therapeutic applications that can improve patients’ health and quality of life.
A RAPIDLY GROWING, VIBRANT SECTOR
While the life sciences ecosystem has expended significant resources in the search for a cure for COVID-19, it is gratifying to see that several companies with other areas of focus have emerged during this time. The following table lists 12 biotech companies focused on developing therapeutics that deserve our utmost respect for raising their first round with institutional investors since the pandemic began in Canada.
This list, which does not claim to be exhaustive, allows us to appreciate the sector’s vitality. The Fonds is proud to have invested directly in three of these promising new businesses, and indirectly through intermediary funds in eight of them.
OUR CONTRIBUTION TO THE WAR EFFORT
The Fonds has always contributed to creating and fostering biotechnology companies. Our modus operandi typically is by participating in traditionally syndicated investment rounds, where several investors join forces to implement a business plan.
Always striving to improve its impact, the Fonds launched
LA CRÉATION D’ENTREPRISES EST UNE ACTIVITÉ PRIMORDIALE POUR LES INVESTISSEURS COMME LE FONDS, autant en étant une source d’entreprise pour bâtir notre portefeuille que du point de vue économique, participant à la création de richesse collective.
Les sciences de la vie est un secteur hautement dynamique permettant de bâtir des entreprises à fort potentiel, générant de nombreux emplois de qualité et contribuant au PIB de la province, tout en développant des applications thérapeutiques capables d’améliorer la santé et la qualité de vie des patients.
UN SECTEUR DYNAMIQUE EN PLEIN ESSOR
Bien que l’écosystème des sciences de la vie ait consacré des ressources considérables à trouver une solution à la COVID-19, il est réjouissant de constater que plusieurs entreprises visant d’autres indications ont émergé pendant cette période. Le tableau ci-dessous présente une liste de douze entreprises de biotechnologie en développement de thérapeutiques qui méritent tout notre respect pour avoir levé leur première ronde auprès d’investisseurs institutionnels depuis l’avènement de la pandémie au Canada. Cette liste, qui n’a pas la prétention d’être exhaustive, nous permet d’apprécier la vitalité du secteur. Le Fonds est fier d’avoir investi directement dans trois de ces nouvelles entreprises prometteuses, et indirectement par fonds interposé dans huit d’entre elles.
LOCATION PARTICIPANTS FIND THERAPEUTICS MONTREAL ADMARE, CTI NEURASIC THERAPEUTICS NOTRE CONTRIBUTION À L’EFFORT DE GUERRE
Le Fonds contribue de tout temps à la création et à l’essor des entreprises de
MONTREAL ADMARE, AMORCHEM PHENOMIC AI TORONTO AV8 VENTURES, CTI, LUMINOUS VENTURES, VIVA BIOINNOVATOR. RADIANT TORONTO AMPLITUDE ABDERA THERAPEUTICS VANCOUVER ADMARE, AMPLITUDE, VERSANT FORUS THERAPEUTICS MONTREAL ADMARE, BEIGENE GIIANT PHARMA MONTREAL AMORCHEM, AMPLITUDE, FONDS DE SOLIDARITÉ GENESYS, THEODORUS CONGRUENCE THERAPEUTICS MONTREAL AMPLITUDE, FONDS DE SOLIDARITÉ EPITOPEA MONTREAL/ CAMBRIDGE (UK) ADVENT LIFE SCIENCE, CAMBRIDGE INNOVATION CAPITAL, CTI FONDS DE SOLIDARITÉ SPECIFIC BIOLOGICS TORONTO ADMARE, LUMIRA VALENCE DISCOVERY MONTREAL AMPLITUDE, BRIGHTSPARK GANDEEVA VANCOUVER AMPLITUDE, LEAPS, LUX
Clarissa Desjardins Claude Perreault Paul Truex
Let’s think outside the box and come up with creative ideas to encourage the development of new life sciences companies built around local science. You have an original project in mind? Let’s meet to discuss it!
an initiative in 2019 to create entrepreneur-oriented businesses. A perfect example of “building the plane while flying it,” these investments are intended to provide entrepreneurs with a proven track record with the means to actualize their business concept so they can raise their first round of institutional financing faster and under better conditions. By choosing trusted, experienced entrepreneurs who share our values, we aim to speed up the process of launching a business.
Guided by this vision, we partnered with Paul Truex in November 2019 to help launch LQT Therapeutics, a project serving to develop inhibitors to treat Long QT Syndrome and resistant cancers. As such, he was able to begin operations and hire his first employees. Our Amplitude Partner Fund jumped on board in January 2021, and our combined support helped provide favorable conditions to secure a US$19 million Series A round in July 2021 and recent additional financing to expedite new development programs.
In September 2021, we happily repeated the experience with Clarissa Desjardins, who was then setting up her 4th company: Congruence Therapeutics, a computational platform targeting rare diseases associated with protein misfolding.
biotechnologie. Notre modus operandi général est de participer à des rondes d’investissement syndiquées de manière traditionnelle, où plusieurs investisseurs joignent leurs forces pour concrétiser un plan d’affaires.
Toujours en quête d’améliorer son impact, le Fonds a lancé en 2019 une initiative de création d’entreprises axées sur l’entrepreneur. Exemple parfait de l’expression « bâtir l’avion en plein vol », ces investissements visent à offrir à un entrepreneur de confiance les moyens de réaliser son concept d’affaires de manière à lui permettre de lever plus rapidement et dans de meilleures conditions une première ronde de financement institutionnel. En choisissant des entrepreneurs expérimentés en qui nous avons confiance et qui partagent nos valeurs, nous visons à accélérer le lancement d’entreprises.
C’est sous cette vision que nous nous sommes joints à Paul Truex en novembre 2019 pour l’aider à lancer LQT Therapeutics, son projet de développement d’inhibiteurs pour le traitement du syndrome du QT long et des cancers résistants. Il a ainsi pu débuter les opérations et embaucher ses premiers employés. Notre fonds partenaire Amplitude s’est joint à l’aventure en janvier 2021 et notre appui conjoint a permis de réunir les conditions gagnantes pour conclure une ronde de série A de 19 M$ US en juillet 2021 et un financement supplémentaire récent pour accélérer de nouveaux programmes de développement. En septembre 2021, nous avons récidivé avec bonheur auprès de Clarissa Desjardins qui s’affairait alors à mettre sur pied sa 4e entreprise, Congruence Thérapeutique, une plateforme computationnelle ciblant les maladies rares associées au repliement défectueux de protéines
Pour combler des besoins plus importants, nous avons travaillé dès le départ avec le fonds Amplitude pour aider à lancer rapidement la société avec une ronde de démarrage de 15 M$ US. L’entreprise a eu un prompt succès en
As this company had greater needs, we worked with the Amplitude Fund from the outset to expedite its launch with a US$15 million start-up round. The company prospered quickly, and as announced in February 2022, it was able to secure a US$35 million extension backed by some prestigious investors.
CONSIDERING NEW LEVERS TO START BUSINESSES
Entrepreneurs, capital, and innovation are the hat trick of creating a business. The work being done by university researchers is an infinite source of innovation that can serve as a foundation for developing new companies.
This retrospective is an opportunity to understand the relative scarcity of new businesses based on Canadian or Quebec university research. Looking at our own activities, we can see that out of nearly one hundred investments made over the years for the development of therapeutics, only ten successful projects’ origins can be traced to Quebec university research. Epitopea, the most recent, stems from the work of Dr. Claude Perrault and Dr. Pierre Thibault of the Institute for Research in Immunology and Cancer affiliated with the Université de Montréal, whose findings have caught the attention of British investors, who joined forces with CTI (a local fund) to launch Epitopea.
An arsenal of complementary means must be deployed to improve this performance. Of particular interest is the Theodorus Fund’s recent initiative with the CQDM biopharmaceutical research consortium, which announced a call for projects to find promising start-ups and support them in launching their businesses. Also noteworthy is adMare’s business creation model (technological maturation in their labs before creating a start-up), which complements the approach of Amorchem, a group specializing in pre-startups in universities (an extreme sport if ever there was one).
Let’s think outside the box and come up with creative ideas to encourage the development of new life sciences companies. You have an original project in mind? Let’s meet to discuss it!
LET’S CONTINUE TO SUPPORT CREATIVITY IN LAUNCHING NEW BUSINESSES
Canada has a vibrant life sciences ecosystem. We’ll be taking advantage of BIO in San Diego from June 13-16 to meet with our neighbours to the south and invite them to be a part of the vibrant ecosystem that exists north of the border.
The Fonds is proud to help create innovative businesses, build a strong economy, and improve patient care. We welcome new ideas and original initiatives which will support entrepreneurs’ ingenuity, leadership and “chutzpah” as they develop their companies.
réussissant à conclure une extension de 35 M$ US annoncée en février 2022 et à laquelle se sont greffés des investisseurs prestigieux.
IMAGINER DE NOUVEAUX LEVIERS POUR LANCER DES ENTREPRISES
Entrepreneurs, capital et innovation représentent la Sainte Trinité de la création d’entreprise. Le travail des chercheurs universitaires est une source incommensurable d’innovations pouvant servir de fondation à l’émergence de nouvelles sociétés.
La présente rétrospective est l’occasion de remarquer la relative rareté de création d’entreprises basées sur de la recherche universitaire canadienne ou québécoise. En examinant nos propres activités, nous constatons que sur près d’une centaine d’investissements effectués au cours des années aux fins de développement de thérapeutiques, seulement dix projets couronnés de succès provenaient de recherche universitaire québécoise. Epitopea, la plus récente, découle des travaux des Dr Claude Perrault et Pierre Thibault de l’Institut de recherche en immunologie et en cancérologie affilié à l’Université de Montréal, dont les découvertes ont capté l’intérêt d’investisseurs anglais, qui se sont unis au fonds local CTI pour lancer Epitopea.
Un arsenal de moyens complémentaires doit être déployé pour améliorer cette performance. Notons l’initiative récente du fonds Theodorus et du consortium de recherche biopharmaceutique CQDM qui ont ouvert un appel à projets pour dénicher des start-ups prometteuses et les accompagner dans le démarrage de leur entreprise. Soulignons également le modèle de création d’entreprise d’adMare (maturation technologique dans leurs laboratoires avant la création d’une start-up), qui opère en complémentarité avec l’approche d’Amorchem, un groupe spécialisé dans le pré-démarrage en milieu universitaire (sport extrême s’il en est un).
Sortons des sentiers battus et proposons des idées créatives pour favoriser l’émergence de nouvelles entreprises en sciences de la vie. Vous avez un projet original en tête ? Venez nous rencontrer pour en discuter !
CONTINUONS DE SUPPORTER LA CRÉATIVITÉ DANS LE DÉMARRAGE DE NOUVELLES ENTREPRISES
Le Canada possède un écosystème dynamique en sciences de la vie. Nous profitons de BIO qui se tiendra à San Diego du 13 au 16 juin pour saluer nos voisins du sud et les inviter à venir participer à l’écosytème dynamique qui existe au nord de la frontière.
Le Fonds est fier de contribuer à la création d’entreprises innovantes, participant à bâtir une économie forte et à améliorer les soins aux patients. Nous accueillons avec enthousiasme les nouvelles idées et les initiatives créatives visant à supporter l’ingéniosité, le leadership et le « chutzpah » des entrepreneurs dans le lancement de leur entreprise.
Bristol Myers Squibb’s Diverse Pipeline Drives Next Wave of Innovation La gamme de produits diversifiée de Bristol Myers Squibb, au cœur de la prochaine vague d’innovation
WITH A LEGACY BUILT ON SCIENTIFIC EXCELLENCE, AND A STRONG INNOVATION ENGINE IN PLACE, Bristol Myers Squibb (BMS) Canada has entrenched itself as one of Canada’s leading biopharmaceutical companies.
“Working to address serious disease with breakthrough science, and then bringing these innovative advancements to Canadians, is at our core as our company,” says Troy André, the Montreal-based general manager of BMS Canada.
This approach has lead to advancements in the development of cancer and immuno-oncology (I-O) treatments, an extensive hematology portfolio, deep expertise in cardiovascular and emerging growth in immunology.
IMMUNO-ONCOLOGY INNOVATION CHANGES SURVIVAL RATES
Ten years ago, BMS Canada was the first company to bring an I-O medicine to Canadians. “Over the last decade, the median overall survival rates for those diagnosed with metastatic melanoma have increased from just over 6 months to now being over 6 years.1 This is a true testament to the impact the field of I-O has had on a serious disease, and it reinforces why innovation is so important to us,” stresses André.
FORTE D’UN HÉRITAGE FONDÉ SUR L’EXCELLENCE SCIENTIFIQUE ET D’UN PUISSANT MOTEUR D’INNOVATION, Bristol Myers Squibb (BMS) Canada s’est imposée comme l’une des principales sociétés biopharmaceutiques du Canada.
« Notre société se concentre sur la lutte contre les maladies graves; elle fait des percées scientifiques, puis fait profiter les Canadiens et les Canadiennes de ces avancées », a déclaré Troy André, directeur général de BMS Canada, société basée à Montréal.
Cette approche a mené à des progrès dans le développement de traitements contre le cancer et en immuno-oncologie, à un vaste portefeuille en hématologie, à une expertise approfondie dans le domaine cardiovasculaire et à l’émergence de nouveaux produits en immunologie.
L’INNOVATION EN IMMUNOONCOLOGIE AMÉLIORE LES TAUX DE SURVIE
Il y a dix ans, BMS Canada a été la première société à offrir un médicament immunooncologique (I-O) aux Canadiens et aux Canadiennes. « Au cours de la dernière décennie, le taux de survie globale médiane chez les personnes ayant reçu un diagnostic de mélanome métastatique est passé d’à peine six mois à plus de six ans2. Voilà une preuve tangible de l’impact que le domaine de l’I-O a eu sur une maladie, qui nous rappelle pourquoi l’innovation est si importante pour nous », souligne Troy André.
INNOVATION IS THE CATALYST FOR EVOLUTIONS IN PATIENT CARE
As treatment options become more widely available to patients, and new standards of care are established, it’s important that
these accomplishments are not accepted as the final frontier of patient care.
“We continue to focus on developing first-in-class and best-in-class medicines to address significant unmet patient needs. One place we’ve done this is in the area of personalized medicines. With many of our investigational therapies and increased disease understanding, we are now able to take a targeted approach to research, subtyping patient populations to help better identify personalized treatment options.”
The development of personalized medicines means that each patient may be able to have their own unique disease management plans, or treatment “road map” that can be followed and revised over time.
RESEARCH PARTNERSHIPS ARE A WIN-WIN IN CANADA
In Canada, BMS’ research approach is exemplified through our strong external research partnerships. “To stay at the center of innovation, we’ve made strategic decisions to strengthen our connections in academia and biotech,” explains André.
For Canadian patients, this means they may have access to more treatment options at an earlier stage. For researchers, particularly in the early in the process, this provides primary experience with new treatment possibilities.
The next five years will be important for BMS Canada. With an expanding treatment portfolio, and one of the most diverse pipelines in the industry, BMS has a major opportunity to help patients and communities manage challenging health conditions.
“We know that we have an important role to bring the next wave of medicines,” says André. “We also believe that Canadian patients who can benefit from our medicines should have access to them. We will continue to work collaboratively with stakeholders, including payers, physicians, and patient advocates to enhance access.” L’INNOVATION EST LE CATALYSEUR DE L’ÉVOLUTION DES SOINS AUX PATIENTS
Même si les options de traitement deviennent de plus en plus accessibles aux patients et que de nouvelles normes de soins sont établies, il est important d’aller au-delà de ces réalisations pour améliorer les soins aux patients.
« Nous continuons de mettre l’accent sur la mise au point de médicaments novateurs qui occupent le premier rang dans leur catégorie pour répondre à d’importants besoins non satisfaits des patients. Nous l’avons notamment fait dans le domaine des médicaments personnalisés. Grâce à bon nombre de nos traitements expérimentaux et à une meilleure compréhension de la maladie, nous sommes maintenant en mesure d’adopter une approche ciblée de la recherche, en classant les populations de patients par sous-type, ce qui nous permet de mieux définir les options de traitement personnalisées. »
Grâce à la mise au point de médicaments personnalisés, chaque patient peut avoir son propre plan de prise en charge de la maladie, ou sa feuille de route pour le traitement, qui seront suivis et révisés au fil du temps.
LES PARTENARIATS DE RECHERCHE SONT AVANTAGEUX POUR TOUS
Au Canada, l’approche de recherche de BMS s’exprime par de solides partenariats de recherche externes. « Pour rester au cœur de l’innovation, nous avons pris des décisions stratégiques afin de renforcer nos liens avec les milieux universitaire et biotechnologique », explique Troy André.
Les patients canadiens ont ainsi accès à plus d’options de traitement, et ce, plus rapidement. De leur côté, les chercheurs, en particulier au début du processus, acquièrent une première expérience de ces nouvelles possibilités de traitement.
Les cinq prochaines années seront importantes pour BMS Canada. Avec un portefeuille de traitements en expansion et l’une des gammes de produits les plus diversifiées de l’industrie, BMS a une occasion en or d’aider les patients et les collectivités à prendre en charge des problèmes de santé difficiles.
« Nous savons que nous avons un rôle important à jouer pour offrir la prochaine génération de médicaments, déclare Troy André. Nous croyons également que les patients qui peuvent profiter des bienfaits de nos médicaments devraient pouvoir y avoir accès. Nous continuerons de collaborer avec les divers intervenants, y compris les assureurs, les médecins et les défenseurs des droits des patients, pour en améliorer l’accès.
Developed in collaboration with our partner Bristol Myers Squibb Canada. Développé en collaboration avec notre partenaire Bristol Myers Squibb Canada.
THE CANADIAN BIOTECHNOLOGY INDUSTRY HAS A COMMERCIALIZATION PROBLEM, researchers across the country publish groundbreaking discoveries at rates similar to other nations but show relatively limited commercial successes. Luckily there is an easy fix – significantly increase investments in the early-stage companies that drive innovation.
When nations make significant investments in their domestic biotech companies scientific discoveries translate into commercial successes. For example, a $25M DARPA grant from the United States government to Moderna to develop mRNA therapeutic technologies in 2013, followed by a $1.53B investment in the company from Operation Warp Speed, enabled the success of its COVID-19 mRNA vaccine.
In contrast to the United States, Canada’s investments in its biotechnology companies have been slow and modest in size. In fact, Canada’s failure to invest in its domestic pharmaceutical industry left it ill-prepared to produce vaccines during the pandemic.
Canada is home to several innovative biotech companies, such as Alberta-based Entos Pharmaceuticals Inc. (Entos), with its Fusogenix proteolipid vehicle (PLV) genetic medicines delivery technology. Entos is at the vanguard of advances in the new frontier of genetic medicine technologies transforming the pharmaceutical industry.
“Canadian companies can contribute significantly to the biomanufacturing industry with breakthrough technologies,” says John Lewis, founder and chief executive officer of Entos. “We have world-class academic centres, highly trained and qualified personnel, and the expertise needed to be a global leader in the growing field of genetic medicines. In fact, the COVID-19 mRNA vaccines use Canadian-developed LNP technology for delivery.” Lewis adds, “but what we don’t have is similar funding support mechanisms compared to our international competitors.”
“The pandemic showed us that having a domestic capacity for vaccine development and biomanufacturing is critical for national security. We can’t depend on other countries to innovate and manufacture medicines for us,” says Dr. Lewis. “Strategic investments from the Canadian government can pay huge dividends by providing Canada with the capacity to manufacture and produce genetic medicines domestically,” he adds.
The biotechnology industry has taken notice of the limitless potential of Entos’ nucleic acid delivery PLV platform. Entos has several pharmaceutical partnerships, including BioMarin and Eli Lilly, that have invested in Entos and its Fusogenix PLV technology to develop cures for rare genetic diseases plus central and peripheral nervous system diseases.
There is a major shift in the pharmaceutical industry towards genetic medicines. Most traditional pharmaceutical drugs are small molecules that target proteins and receptors known to cause disease symptoms. Genetic medicines comprise a viral or lipid nanoparticle platform that carries genetic cargo for delivery inside cells to target the root cause of the disease and uses the cells’ replication machinery to amplify treatment.
“Because of the huge success of COVID-19 mRNA vaccines, we’re going to see a wave of new genetic medicines against every disease plaguing humanity,” says Dr. Lewis, who predicts that within 20 years, half of the medicines we take will be genetic medicines.
However, challenges remain for the widespread adoption of genetic medicines as therapeutics. The first challenge is
having a flexible and safe delivery vehicle that can protect and effectively deliver the genetic cargo into the cell.
“Traditional viral and lipid nanoparticle delivery platforms can only address about ten percent of the diseases due to limitations around redosing and poor tolerability. Viral-based platforms can’t be administered to a patient more than once due to immunogenicity concerns and lipid nanoparticles are poorly tolerated by the body, limiting dosing levels,” says Dr. Lewis.
Fusogenix PLVs overcome these limitations by combining the best features of viral and lipid nanoparticle delivery platforms. PLVs are formulated with the smallest known viral fusion peptide and well-tolerated lipids to safely and efficiently deliver any cargo directly into the cell. With PLVs, “we can deliver genetic medicine to the right cell at the right time to provide a therapeutic effect, so we can re-dose with much lower toxicity than the current delivery platforms,” Dr. Lewis explains.
During the pandemic, Entos used its Fusogenix PLV platform to develop a DNA-based COVID-19 vaccine called Covigenix. In under a year, Entos brought Covigenix to Phase I clinical trials.
“We created a DNA based vaccine that appears effective at low doses, similar in range to the current mRNA COVID-19 vaccines. This low dose compares favourably to other DNA vaccines that use much higher doses of DNA,” says Dr. Lewis. He also notes that RNA vaccines need to be kept very cold to remain stable, making shipping and storage expensive and not universally available.
Although the mRNA-based COVID-19 vaccines have proven safe and effective, the Fusogenix PLV DNA vaccine offers the important advantage of stability at refrigerator temperatures and appears effective as a single shot with high durability over time. Entos’ vaccine is now in Phase II clinical trials in Africa to study its immunogenicity and safety. “Once we have this data, we plan to run Phase III clinical trials in North America to evaluate its effectiveness as a COVID-19 booster,” Lewis says.
Another major challenge genetic medicine manufacturers must overcome is the ability to significantly increase the scale of production of these therapeutics. Again, the COVID-19 pandemic helped mitigate this challenge with the swift deployment of many new facilities worldwide to meet demand. However, demand still exceeds supply and production capabilities, and significant infrastructure investments are required to support this rapidly expanding industry.
Federal investments in homegrown biotechnology companies with new programs like the Canada Growth Fund will allow Canada to re-establish itself as a leader in the pharmaceutical industry. If Canada invests quickly to take advantage of the genetic medicine momentum, the nation could meet the demand for genetic medicines within and outside its border.
Entos is excited to be a part of this industry. Through its Fusogenix PLV technology, it is ready to play a leading role in Canada, contributing to the innovation and manufacturing of this new generation of genetic medicines. With increased federal support Entos and other genetic medicine companies in Canada will be able to translate their scientific breakthroughs into vaccines and therapeutics, helping to save lives and build our economy. Let’s invest in Canadian biotechnology companies to re-build the industry and lead the future of genetic medicines.
