The Company has achieved impressive pre-clinical efficacy results utilizing the gastrointestinal (GI) mucosal cells to induce expression of therapeutic proteins in two common, chronic diseases:
- localized delivery of the anti-
inflammatory cytokine IL-10 to the colon for treating inflammatory bowel disease (IBD); and
- a treatment to regenerate physiologic, meal-regulated insulin secretion from the gut of subjects with diabetes.
Proof-of-concept has been established for several additional applications, including siRNA delivery to various tissues to suppress expression of disease-causing proteins.
The Company has an extensive patent library on the compositions, methods and manufacturing processes for its technologies. Additionally, enGene is enabling its technology to be administered in several fashions - including oral, enema, inhalation and injection - to expand its potential applications into a broad array of diseases.
Since that initial discovery, scientists have published findings that demonstrate that K-cells are very similar to the beta-cells that produce insulin, in that both are sensitive to glucose levels in the body and both secrete specific hormones in response to the level of glucose that is present.
In 2000, two former students of Dr. Brown, Drs. Anthony Cheung and Timothy J. Kieffer, discovered a novel way to use Dr. Brown's research to treat diabetes. Drs. Cheung and Kieffer discovered how to coax K-cells to produce and secrete insulin in response to ambient glucose levels.
enGene's portfolio now encompasses a broad range of drug candidates drawing on its world-leading expertise in using biopolymers to deliver nucleotides.
The work of our researchers and Management are complemented by several seasoned executives and external consultants with expertise in drug development, clinical and regulatory affairs, project management, supply chain management and manufacturing.
enGene has established a dominant intellectual property estate over the delivery of nucleotides to the intestinal tract and other mucosal tissues. enGene has numerous granted and pending patents, which can be broadly categorized into the following:
A. Composition and method for targeting gene expression to gut endocrine cells for regulated protein production. enGene also holds a series of granted and pending patents that address the use of orally delivered DNA vectors to target protein expression to gut endocrine cells for the treatment of diabetes and obesity.
C. Composition and method for modifying chitosan for delivery of siRNA and DNA. enGene recently developed a modified form of chitosan that allows for maintenance of particles stability in neutral pH. It has been demonstrated that these novel modified chitosans significantly improved the efficiency of siRNA in vivo.
D. Process for manufacturing stable and highly concentrated chitosan-nucleotide particles.
IBD is a group of inflammatory conditions of the colon and small intestine. The major types of IBD are Crohn's disease and ulcerative colitis. IBD is one of the most prevalent gastrointestinal diseases in the United States and Canada affecting more than 1.6 million North Americans. In Europe, the number of people with IBD is estimated to be 2.2 million. Currently, IBD is under-diagnosed, especially in developing countries. As governments and other healthcare providers address chronic illnesses like IBD, this market will expand in many countries.
Annual sales of drugs to treat IBD exceeded $5 billion in 2009, and are expected to increase significantly. Main growth drivers of IBD drug sales are increasing disease prevalence, improving diagnosis and wider access to treatments. Current IBD therapeutics are not always effective, and this presents a significant market opportunity for the identification and development of new and more effective treatments.
INFLAMATORY BOWEL DISEASE
Diabetes is a chronic metabolic disorder that is caused by failure of the body to produce insulin and/or an inability of the body to respond adequately to circulating insulin. There are two main types of diabetes: type 1 diabetes, which is caused by autoimmune destruction of pancreatic beta-cells, leading to drastic deficiency or absence of insulin; and type 2 diabetes, which is caused by a combination of insulin deficiency and an inability of insulin to act optimally at target organs.
Diabetes is now considered to be pandemic; the World Health Organization estimates that diabetes affects over 220 million people worldwide, and the prevalence will double to 300 million people by 2025 . In the US alone, nearly 24 million people, or eight percent of the population, have diabetes. The annual direct medical cost of diabetes in the US was approximately $116 billion in 2007. And it is not just in the US that the number of afflicted is growing; China, Brazil, Russia and India are expected to see sharp increases.
The opportunity for enGene in the diabetic market is enormous, given the potential of EG-02 to regenerate an internal self-regulating insulin delivery system that produces and releases insulin in the proper quantity and at the appropriate time, to regulate blood glucose levels in diabetic patients.
In addition to insulin, enGene is also applying its technology to deliver Glucagon-Like Peptide-1 (GLP-1). GLP-1 is a hormone that is released from the intestine during a meal and its acts on pancreatic beta-cells to increase insulin secretion. Byetta™ is the first GLP-1 analog, and was approved in late 2005 for use in patients with type 2 diabetes.
ERIC C. HSUVP Scientific Affairs & Operations
Dr. Eric C. Hsu joined enGene as a Scientist in 2002 and promoted to his current position in 2006. Dr. Hsu's current role at enGene includes overseeing scientific activities related to pre-clinical studies, formulation, process and assay development, as well as managing internal scientific staff and external Contract Research Organizations (CRO). He is also responsible for expanding product pipelines.
Dr. Hsu is an expert in the field of gene transfer and gene expression using viral and non-viral vector systems. During his graduate studies, Dr. Hsu characterized receptor-mediated entry for gene transfer vectors. His findings provided invaluable information in improving the existing vaccine development and in developing new cancer therapies.
Dr. Hsu conducted a post-doctoral fellowship at the Amgen Research Institute, where he developed a novel gene therapy approach for treating Hepatitis C virus (HCV), a disease affecting more than 200 million people worldwide. His research works were published in a variety of respected journals, including Nature Biotechnology.
Dr. Hsu received his Bachelor's degree from McGill University and his Doctoral degree from the Department of Medical Biophysics at University of Toronto in 1999.
ANTHONY T. CHEUNG, PhDPresident and CEO
Dr. Anthony T. Cheung co-founded enGene and served as the Chief Scientific Officer from 2004-2011. He was appointed as CEO of enGene in May 2011. Dr. Cheung received his doctorate degree in Physiology from the Tulane University School of Medicine in New Orleans. Dr. Cheung has co-authored numerous book chapters, review articles and peer-reviewed journals on the topics of diabetes, gene therapy and autoimmune diseases. His research has been published in many prestigious scientific journals, including Science and Proceedings of the National Academy of Science. He has been invited to speak at many international scientific and biotechnology conferences - BIO, American Society for Gene & Cell Therapy, Diabetes Technology Meeting, Children with Diabetes - on topics related to gene therapy, diabetes and bio-entrepreneurism. He also serves as Board Member and Advisor for several biotechnology companies and professional organizations including Bio-Industry Liaison Committee of the American Society for Gene & Cell Therapy and Student Biotechnology Network of BC.
IVAN T. SHAW, PhDVP Clinical Development
Dr. Ivan T. Shaw is a Clinical Development, Regulatory Affairs and Medical Affairs professional who holds significant expertise with small molecule, biologics and orphan drug development in both pediatric and adult populations. He has led multiple successful US NDA and EU MAA submissions.
Prior to joining enGene, Dr. Shaw served as Medical Director, Medical Affairs within the Branded Products division of Actavis, managing and facilitating the launch of products within their analgesics franchise. Prior to Actavis, Dr. Shaw was the Director, Clinical Development at Aptalis Pharma (formerly Axcan Pharma Inc), a specialty gastroenterology-focused pharmaceuticals company, where he developed and completed 13 Phase 1-4 clinical studies, including multiple pediatric programs, and created Clinical Development programs for next-generation products to address unmet medical needs in multiple therapeutic areas. Dr. Shaw has also held positions of increasing responsibilities at Actelion Pharmaceuticals Canada, PAREXEL International, and Merck Frosst Canada.
Dr. Shaw holds both a Doctorate and Master’s Degree in Neurology and Neurosurgery in addition to an undergraduate degree in Interdepartmental Honors Immunology from McGill University.
MICHÈLE JÉMUS, CPA, CA, M.ScChief Financial Officer
Michèle joined enGene in February 2016. She has more than 20 years of experience in finance and operations working with a number of high growth health care companies. Prior to joining enGene, Michèle served as Senior Vice President of Finance at the oncology software division of Elekta AB, a publicly traded company headquartered in Sweden that develops and markets advanced radiation oncology products. She had joined Elekta in 2010 following their acquisition of Resonant Medical (Montreal, Canada), where she was serving as the Chief Financial and Operating Officer since 2004. Michèle also served as the Chief Financial Officer for Intellivax, Inc. (Montreal, Canada), which was acquired by ID Biomedical. She started her career in audit and corporate finance consulting, working for Raymond Chabot Grant Thornton and KPMG. Michèle received her M.Sc. in Finance from Université de Sherbrooke and she is a licensed Chartered Professional Accountant (CPA, CA).
VICTOR KNOPOV, PhDChief Techonology Officer
Dr. Victor Knopov is a renowned expert in pharmaceutical development with over thirty years of experience. He has held leadership positions overseeing Chemistry, Manufacturing and Control (CMC) component of drug development for products ranging from pre-clinical to commercial stage. Dr. Knopov has extensive knowledge in the CMC aspect of a broad range of pharmaceutical products, including commercial production of enzymes, anticancer small molecules and liposomal products. More recently, he has had multiple successes in developing advanced delivery systems for siRNA, microRNA, antisense,and plasmids that are based on lipids, polymer nanoparticles and conjugated systems. Throughout his career, Dr. Knopov has successfully executed multiple global manufacturing campaigns for complex drug modalities including novel excipients, drug substances and drug products.
Prior to joining enGene, Dr. Knopov had served as the Vice President of Pharmaceutical Development at Regulus Therapeutic (San Diego, CA) since 2012. He was in charge of all CMC activities at Regulus and was a member of the executive team responsible for the development of the company’s clinical pipeline. He joined Regulus when all their novel miRNA-based products were still at the pre-clinicial stage and he brought 3 products to clinical testing by the time he left the company. Prior to Regulus, Dr. Knopov led CMC development at Nitto Denko Technical Corporation (San Diego, CA). During his tenure at Nitto Denko, Dr. Knopov developed a unique liver-targeted siRNA delivery system for treating advanced non-alcoholic steatohepatitis (NASH) and post-HCV cirrhosis. He oversaw the development of this novel siRNA delivery technology from idea conception through to entry into human clinical trials. In 2016, Bristol-Myers Squibb paid a $100M upfront payment to Nitto Denko to obtain an exclusive worldwide license for this siRNA delivery technology.
From 2008 to 2010, Dr. Knopov was the Chief Operating Officer at Diversified Bio-Medics, Inc., which focused on the development of a single-use platform for biologics manufacturing. From 1997 to 2008, Dr. Knopov held various pharmaceutical manufacturing positions with increasing responsibilities at Inex/Tekmira Pharmaceuticals Corporation (Vancouver, BC), where he led the development of several internal liposome-based products and managed multiple partnered programs in siRNA delivery.
ANTHONY T. CHEUNG
Dr. Anthony T. Cheung co-founded enGene, and served as the President and CEO until March 2004. During that period, he raised significant financing through private and public channels to fund the development of enGene. Dr. Cheung has been serving as the Chief Scientific Officer and corporate secretary of enGene since 2004. As CSO, Dr. Cheung oversees the scientific team, ensuring that the research and development functions set and achieve key value-driving milestones. Dr. Cheung has co-authored numerous book chapters, research and review articles on the topics of diabetes and gene therapy, which have been published in many prestigious scientific journals, including Science, Diabetes, Proceedings of the National Academy of Science and Endocrinology.Dr. Cheung received his doctorate in physiology from the Tulane University School of Medicine in New Orleans, where he focused on diabetes research, and holds a bachelor of science in biochemistry from the University of British Columbia. Dr. Cheung and Kieffer discovered the use of gut K-cells as surrogate cells of insulin production, which formed the foundation for enGene's insulin replacement therapy.
Dr. Underdown is Managing Director of Lumira Capital, a later-stage venture capital company with investments in companies throughout North America. During his venture capital career, Dr. Underdown has been responsible for investments in life sciences companies at all stages of development with a particular focus on therapeutics. He had earlier been Assistant Vice-President for Research at Pasteur Merieux Connaught, where he headed the Canadian Universities Research program and several global programs to develop vaccines. During his academic career, he was Associate Dean of Research at the University of Toronto’s Faculty of Medicine and at McMaster University’s Faculty of Health Sciences. Dr. Underdown has held senior positions on national and international bodies concerned with science policy and university-industry collaboration. He has served on boards of such life sciences companies as Argos Therapeutics, Ception Therapeutics, Cytochroma Inc., Golden Horseshoe Biotechnology Network, ID Biomedical, Nysa Membrane Technologies, Trillium Therapeutics, Transmolecular Therapeutics, and Viron Therapeutics. He received his PhD in Immunology from McGill University and undertook postdoctoral studies at Washington University School of Medicine in St. Louis.
RICHARD M. GLICKMAN
Dr. Richard Glickman was a co-founder and CEO of Aspreva Pharmaceuticals. Under his leadership, Aspreva went public within 4 years from startup with an $80-million initial public offering, the largest in Canadian biotech history. Aspreva was acquired 6 years after its founding for nearly US$1 Bln in October 2007. Prior to Aspreva, Richard was the co-founder and CEO of StressGen Biotechnologies Corporation, where he grew the company from startup to a major biotechnology player with a market capitalization of over $500 million. He was also the founder and a director of Ontario Molecular Diagnostics, which evolved into the largest molecular diagnostic laboratories in Canada. Richard also co-founded Probtec Corporation, a rational drug design and molecular genetics firm, where he established and introduced the first licensed DNA-based forensic and paternity testing services in Canada. He has served on numerous biotechnology boards including roles as Chairman of Life Sciences B.C., Director of the Canadian Genetic Disease Network and a member of the federal government's National Biotechnology Advisory Committee. Richard received the Ernst & Young Entrepreneur of the Year Award in 2004; both Canada's and British Columbia's Top 40 under 40 Award for Entrepreneurs; and the BC Biotech Leadership Award in 2006. Richard currently serves as a director for a number of private and public biotechnology companies.
SANDER VAN DEVENTER
Sander van Deventer is a founder and managing partner of Forbion Capital Partners. He serves as a non-executive on the boards of Argos Therapeutics, Inc., giCare Inc., Hookipa AG, uniQure NV and enGene, Inc. Sander is a professor in Translational Gastroenterology at the University of Leiden and an accomplished scientist: he has authored more 400 peer review scientific papers and supervised more than 40 PhD students. Sander van Deventer, a certified internist and gastroenterologist, received his medical degree and doctorate (of philosophy) from the University of Amsterdam, after defending a thesis on the biological activities of bacterial lipopolysaccharides in humans. Following board certification in internal medicine and gastroenterology, he worked as a scientist in the Laboratory for Medical Biochemistry, Rockefeller University, New York. He was the first to administer an anti-TNF monoclonal antibody (later registered as Remicade®) to patients with Crohn’s disease, the first to infuse apolipoprotein A1 in humans and played a critical role in the development of other therapeutic interventions, targeting cytokines, cytokine receptors, T-cells and signal transduction pathways, using small molecules, antibodies, peptides, proteins and antisense DNA technologies. In 1995, he was appointed director of the laboratory for Experimental Internal Medicine at the Academic Medical Center in Amsterdam, and continued to work on therapeutic signal transduction inhibition, gene therapies, and (genetically engineered) probiotics. From 2001 until 2004, he chaired the Department of Gastroenterology and Hepatology at the Academic Medical Center in Amsterdam. In 1998, he co-founded Amsterdam Molecular Therapeutics (AMT N.V.), currently uniQure B.V., which is developing AAV-based gene therapy products and is now listed on NASDAQ, he has acted subsequently as CSO, CMO and CEO. He supervised the development of Glybera, the first gene therapy product to be approved in Europe, as well as several other gene therapy products.
DENNIS H. LANGER, M.D., J.D.
Dennis H. Langer, M.D., J.D. has served as a Director of several biotechnology, specialty pharmaceutical, and diagnostic companies, and has been CEO and/or co-founder of several health care companies. From 2005 to 2010, Dr. Langer served as a Managing Partner of Phoenix IP Ventures, a private equity/venture capital firm specializing in life sciences. Previously, he was President, North America, of Dr. Reddy's Laboratories, Limited. From September 1994 until January 2004, Dr. Langer held several high-level positions at GlaxoSmithKline plc, and its predecessor, SmithKline Beecham, including most recently as a Senior Vice President of Research and Development. Prior to SmithKline Beecham, Dr. Langer was President and CEO of Neose Technologies, Inc., and before that held R&D and marketing positions at Eli Lilly, Abbott and Searle. At the beginning of his career, he was a Chief Resident at Yale University School of Medicine, and held clinical fellowships at Harvard Medical School and the National Institutes of Health. Dr. Langer serves as a Director of Myriad Genetics, Inc., Dicerna Pharmaceuticals, Inc., Delcath Systems, Inc., and several private companies. Previously, Dr. Langer served as a Director of Ception Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen Corporation (acquired by EUSA Pharma Inc.), Pharmacopeia, Inc. (acquired by Ligand Pharmaceuticals, Inc.), Sirna Therapeutics, Inc. (acquired by Merck and Co., Inc.), and Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr. Langer is a Clinical Professor in the Department of Psychiatry, Georgetown University School of Medicine. Dr. Langer received a J.D. from Harvard Law School, an MD from Georgetown University School of Medicine, and a B.A. in Biology from Columbia University.
JOHN C. BROWN, PhD, DSc, FRSCDr. Brown is a professor (emeritus) at the University of British Columbia and an honorary professor at Beijing Medical University, P.R.C. His research interests have been in the fields of diabetes, obesity and gastrointestinal physiology. He is a pioneer in gut peptides having discovered two important GI hormones in the 1970s, GIP (the hormone made by the gut cells targeted by enGene's technology) and motilin. Dr. Brown was a co-founder of Quadra Logic Technologies Ltd. (now QLT Inc.), of Immgenics Pharmaceuticals, and of enGene, Inc. He has also served as a consultant for major multinational pharmaceutical companies.
KEVAN JACOBSON, MDDr. Jacobson has been a pediatric gastroenterologist at the B.C.'s Children's Hospital since 1999. He obtained his medical degree at the University of the Witwatersrand in Johannesburg, South Africa, thereafter completing his internal medicine degree and then adult gastroenterology at McMaster University Medical Centre. Dr. Jacobson is presently an associate professor, and a C.H.I.L.D./C & W Foundation Senior Clinician Scientist in the department of pediatrics, in the division of gastroenterology and CFRI. He is the director of the IBD research program at UBC.
JAY K. KOLLS, MDDr. Kolls is professor of genetics and pediatrics, and chair of the department of Genetics at the Louisiana State University Health Sciences Center in New Orleans. Dr Kolls was recruited on January 2009 from the Children's Hospital of Pittsburgh at the University of Pittsburgh in Pittsburgh, Pennsylvania, where he was the Niels K Jerne Professor Pediatrics and Immunology. He earned his medical degree at the University of Maryland, and completed his residency training in Internal Medicine/Pediatrics at Charity Hospital in New Orleans, LA. He performed his research fellowship in the laboratory of Dr. Bruce Beutler at Howard Hughes Medical Institute, at UT Southwestern Medical Center, Dallas, Texas. Dr. Kolls is a member of the American Association of Immunology, American Society of Microbiology, and the American Society of Clinical Investigation. The major focus of Dr. Kolls' research is to investigate mechanisms of mucosal host defenses in normal and immunocompromised hosts using genetic models. Presently, his lab is investigating how IL-23 and IL-17 and IL-22 regulate host defense against extracellular pathogens and epigenetic regulation of macrophage function. Additionally, he researches host susceptibility to opportunistic infection such as pneumocystis, and is developing pre-clinical gene-based vaccines against this pathogen. Dr. Kolls has authored or co-authored more than 160 peer-reviewed articles and acts as a consultant to several industry leaders including Immunex and Agbenix (now both Amgen), Zymogenetics and Inhale Therapeutics (now Nektar).
RUSSELL MUMPER, PhDDr. Mumper is the Executive Assoc. Dean for Academics and the John A. McNeill Distinguished Professor at the UNC Eshelman School of Pharmacy at the University of North Carolina (UNC) at Chapel Hill. He also serves as the Director of the Center for Nanotechnology in Drug Delivery at UNC. Dr. Mumper's current research interests include nanotechnology-
based delivery systems for cancer drugs and vaccines, drug-polymer conjugates, and trans-mucosal drug/vaccine delivery. Prior to joining UNC, Dr. Mumper was the Vice Chair of the Dept. of Pharmaceutical Sciences in the College of Pharmacy at the University of Kentucky. Dr. Mumper was also the Assoc. Dir. of the Center for Pharmaceutical Science & Technology, a unique university-based fully integrated FDA-registered GMP pharmaceutical manufacturing facility. Dr. Mumper previously held various product development positions with Burroughs Wellcome Co, GeneMedicine Inc., and ViroTex Corporation. He has more than 215 scientific publications/abstracts and 38 granted and pending patents. Notably, he was the first scientist to demonstrate the use of chitosan as a carrier for nucleotides, and holds the earliest patent in this field. He has co-founded four companies based on technologies developed in his academic laboratories. Dr. Mumper received a B.A. in Chemistry and Ph.D. in Pharmaceutical Sciences from the University of Kentucky.
CHRISTOPHER J. RHODES, PhDDr. Rhodes is a Professor of Medicine in the Endocrinology Division of the University of Chicago. He has a distinguished career in the field of diabetes, having been the recipient of numerous awards, grants and honors from several US and international organizations and has authored over 225 scientific publications in the field. He has worked closely with the Juvenile Diabetes Research Foundation and the American Diabetes Association, having chaired several of their committees and scientific sessions. Dr. Rhodes is also an Associate Editor for the prestigious journal Diabetes. He serves in several advisory capacities for industry leaders such as Eli Lilly, Merck, Amylin and Takeda.
PAUL D. ROBBINS, PhDChairman of the Scientific Advisory Board
Dr. Robbins is a professor in the department of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. He is also director of basic research for the institute for molecular medicine and the vector core facility at the same university. Dr. Robbins is a pioneer and world-renowned leader in innovative gene delivery technologies. His research programs attract considerable public and private funding and he has generated over 390 scientific articles and 23 patent applications in the field of gene therapy. He has received numerous awards, serves as associate editor for the journals Gene Therapy and Cancer Research, and sits on numerous other editorial boards. Dr. Robbins also acts as consultant to several well-established gene therapy companies including Cell Genesys and Valentis Corporation. He is involved with the Juvenile Diabetes Research Foundation and American Diabetes Association on several projects.
BRIAN G. FEAGAN, MD, FRCPCDr. Feagan is Professor of Medicine in the Division of Gastroenterology and Director of Robarts Clinical Trials at the University of Western Ontario, London, Canada. Robarts Clinical Trials is a premier academic CRO focusing on IBD and it was responsible for successfully executing numerous important controlled randomized trials that have transformed the management of IBD. Dr. Feagan's research efforts focus on the design and implementation of randomized controlled clinical trials and he has been the lead investigator on numerous large-scale randomized clinical trials for new IBD treatments. He has authored several book chapters and served as Editor for several books, including Evidence-Based Gastroenterology and Hepatology (2010, 3rd Ed). His research is very well published in many front ranked peer-reviewed medical journals, including 10 Original Article in New England Journal of Medicine.
GEERT D'HAENS, MD, PhDDr. D'Haens is Professor of Inflammatory Bowel Diseases and Head of the Academic Medical Centre (AMC)-IBD Unit at the University of Amsterdam, Netherlands. The AMC-IBD Unit is well known for spearheading many important developments in the treatment of IBD. Dr. D'Haens also founded and led the Imelda GI Clinical Research Centre in Belgium, where clinical testing of many new medications for IBD and colorectal cancer were conducted. In addition, he was the past President of the Flemish Society of Gastroenterology and co-founder of the European Crohn's and Colitis Organization. Currently, he serves as Scientific Secretary for the International Organization for Inflammatory Bowel Disease (IOIBD) and Chairman of its Clinical Trials Task Force. Dr. D'Haens' main research interests are in the fields of IBD, mucosal immunology, gastrointestinal endoscopy and immunosuppression. He has published over 120 articles in peer-reviewed journals and 27 chapters in medical textbooks.
RICHARD N. FEDORAK, MD, FRCPC, FRCP (London)Dr. Fedorak is the Associate Vice President for Research and a Professor of Medicine in the Division of Gastroenterology at the University of Alberta, Edmonton, Canada. He also serves as Director for the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR) and Director of the Northern Alberta Clinical Trials and Research Centre (NACTRC). Outside of the University, he is the President of Canadian Digestive Health Foundation (CDHF) and Chairman of World Gastroenterology Organization Research Committee. Previously, Dr. Fedorak has served as President of the Canadian Association of Gastroenterology, General Secretary of the Pan American Congress of Gastroenterology and President of the World Congress of Gastroenterology. Dr. Fedorak has an active basic gastrointestinal research laboratory and he leads a large clinical research group that focuses on gastrointestinal diseases. He has been leading clinical development of many novel IBD treatments. Dr. Fedorak has published over 400 peer-reviewed manuscripts and book chapters. He holds editorial positions with several medical journals.
ALBERT COHENAlbert Cohen attended McGill University and the Université de Montreal where he completed his medical training and specialization in gastroenterolgy in 1990. He joined the Jewish General Hospital in 1993 where he launched the therapeutic endoscopy program and headed the inflammatory bowel disease unit at the hospital. His research interests lie primarily in the development of new therapies for Crohn's disease and colitis and was very involved in the development of Remicade and Humira for IBD. He has co-authored numerous scientific articles, primarily in the field of IBD. He is an associate professor in the faculty of medicine at McGill University and has been the director of the division of gastroenterology at the Jewish General Hospital since 2000.
There is a high unmet medical need for effective delivery of therapeutic proteins to treat diseases of the mucosal tissues (e.g. digestive tract, lung, bladder, uterus). In many cases, localized or topical drug delivery, such as enGene's approach, is the preferred route of administration, as systemic delivery through the bloodstream does not provide sufficient drug levels at the site of disease, and often leads to unwanted side effects throughout the body. enGene's technology improves the local levels of protein drugs in the mucosal tissues while minimizing systemic drug exposure, thus setting the stage for improving both safety and efficacy. We have demonstrated the feasibility of this approach in treating inflammatory bowel disease.
intestinal mucosal cells to express therapeutic proteins to treat two chronic diseases:
- Inflammatory bowel disease: our technology provides delivery of the potent anti-inflammatory cytokine, IL-10, locally in the colon at the site of disease.
- Diabetes: our technology provides an insulin replacement therapy by regenerating meal-regulated insulin secretion from the gut.
enGene's system utilizes a natural, non-toxic and biocompatible polymer as carrier for nucleotides. The polymer protects the nucleotides from degradation and promotes their uptake into cells. A simple and highly scalable manufacturing process to make consistent nucleotide-containing nanoparticles at a concentration that is clinically relevant and at a scale that is commercially viable, has been developed enGene has also successfully adapted its technology for the efficient delivery of siRNA, a highly promising approach to treating disease, but with significant challenges in its delivery.
There are several important shortcomings with the current drug therapies for IBD: they are not curative and the treatments come with significant systemic side effects. Recently, injectable biologics or protein drugs that inhibit TNF-alpha (e.g. Remicade® and Humira®)* have been approved as treatment for IBD. Although these protein drugs are generally effective in inducing and maintaining disease remission in patients, there are many serious and undesirable side effects associated with prolonged usage. These side effects include increased risk of developing tuberculosis, pneumonia, various infections and some cancers.
*Remicade and Humira is a registered trademark of Centocor Ortho Biotech, Inc and Abbott, respectively
enGene has demonstrated significant proof-of-efficacy results in several mouse models for IBD, and has demonstrated the feasibility of repeated dosing in the pig model. We aim to conduct its first-in-man study for EG-10 in Canada soon, and has also identified a clinical site with a world-renowned investigator in IBD clinical trials to conduct the Phase 1/2a study for EG-10.
By enabling the body to produce and release anti-inflammatory proteins in the proper quantities at the disease site, our technology has to potential to provide an effective and important alternative to current treatments for persons with IBD.
enGene's innovative technology, EG-02, regenerates the body's own ability to produce insulin in a meal-dependent fashion, resulting in effective control of blood glucose levels. The technology focuses on converting a discrete population of cells in the gastrointestinal tract, the K-cells, to function as insulin producers.
What Is Diabetes?
What Is Diabetes?
In 2006, a Nobel Prize was awarded to the scientists who discovered the mechanism of action for siRNA. Although the therapeutic potential of siRNA has been convincingly demonstrated in pre-clinical models for a wide variety of diseases, the safe and efficient delivery of siRNA has remained a primary challenge in the clinical application of siRNA-based medicines. enGene has recently derived a novel, modified chitosan formulation to package siRNA at a very high loading efficiency. These nanoparticles, when given to test animals, are highly effective in knocking-down the expression of specific genes in a variety of tissues.
The market potential for enGene's technology is substantial, based on the rapidly growing number of therapeutic proteins on the market, and the need for improved delivery technologies.
January 31st, 2017ENGENE BOLSTERS ITS LEADERSHIP TEAM WITH THE APPOINTMENT OF DR. VICTOR KNOPOV AS CHIEF TECHNOLOGY OFFICER
March 15th, 2016ENGENE INC. ANNOUCES THE APPOINTMENT OF MICHÈLE JÉMUS AS CHIEF FINANCIAL OFFICER
January 11, 2016Takeda And enGene Establish Strategic Alliance to Develop Novel Therapeutics For Gastrointestinal Diseases
December 8, 2015ENGENE INC. ANNOUCES THE APPOINTMENT OF DR. DENNIS H. LANGER TO THE COMPANY’S BOARD OF DIRECTORS
October 14, 2015ENGENE ANNOUNCES STRATEGIC COLLABORATION WITH JOHNSON & JOHNSON INNOVATION TO DEVELOP NOVEL GENE DELIVERY PRODUCTS FOR INFLAMMATORY BOWEL DISEASE
February 16, 2015Adiition of Two Key Members to enGene’s Senior Management and Scientific Advisory Board
January 26, 2015enGene raises CAD 13.5 million to develop intestinal gene delivery platform
August 1, 2013Lumira Capital announces investment in enGene, Inc.
January 24, 2012World-leading Inflammatory Bowel Disease Clinical Investigators Join enGene's Newly Established Clinical Advisory Board (PDF)
October 19, 2011enGene, Inc. appoints Dr. Richard M. Glickman to the company's Board of Directors and announces changes to its Board composition (PDF)
February 2, 2011enGene, Inc. CEO to Present at BioPartnering North America Conference (PDF)
December 6, 2010enGene, Inc. CSO to Present Key Pre-clinical Data on EG-10 for Treating Inflammatory Bowel Disease (PDF)
November 2, 2010enGene CEO Interviewed by BioTuesday (PDF)
September 1, 2010enGene, Inc. Adds Leading Nanomedicine Expert to Scientific Advisory Board (PDF)
June 10, 2009enGene, Inc. Receives NRC-IRAP Contribution, Initiates Convertible Note Financing (PDF)
enGene Inc. is a rapidly growing, dynamic biopharmaceutical company focused on developing therapies for inflammatory and metabolic human diseases. Our company is developing a highly flexible, biopolymer-based nucleotide delivery technology targeting mucosal tissues to treat diseases. The lead program is the localized delivery of a gene that expresses the anti-inflammatory cytokine, IL-10, for treating Inflammatory Bowel Disease.
Everyone at enGene plays a vital role in the discovery and delivery of these breakthrough therapies. It takes passion, creativity, collaboration, persistence and focus to do what we do. If you possess these qualities and thrive on working in a fast-paced, team-based environment, then enGene may be the place for you.
JOB OPENINGSAccounting and procurement clerk
Director of Quality Assurance
Financial Planning and Contracts Analyst
Project Coordinator CMC
Research Associate Assay
Scientist Manufacturing and Formulation Process
Senior Research Associate Analytical Development and Quality Control
Senior Research Associate Manufacturing and Formulation Process
Senior Scientist for DNA Manufacturing and Analytical Characterization
Senior Scientist Oral Dosage
Techinical Writer CMC
Techinical Writer R&D
Vice President Preclinical Development