01
COMPANY
01
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.
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.
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. Kieffer is enGene's Vice President of Research and a company co-founder. Dr. Kieffer is a professor in the departments of cellular and physiological sciences and surgery at the University of British Columbia. At UBC, Dr. Kieffer oversees the Laboratory of Molecular and Cellular Medicine, where his team conducts diabetes and obesity research complementary to that of enGene. He is also the head of the UBC Diabetes Research Group. He is a recognized expert in the field of gut endocrine hormones, and is a frequent lecturer on this topic at numerous international scientific conferences. He serves on the editorial board for Physiological Reviews and the Canadian Journal of Diabetes, and is frequently on review committees for several national and international diabetes funding agencies. His academic research programs are supported by the Canadian Institutes of Health Research, Networks of Centres of Excellence, the Canadian Diabetes Association, the Michael Smith Foundation for Health Research and the Juvenile Diabetes Research Foundation.
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.
Mr. Adams has more than twenty years of experience in pharmaceutical product development, commercialization and partnerships. He has held management positions in the pharmaceutical and biotechnology industry in North America and Europe with several companies, including Abbott Laboratories Inc. and Fresenius AG and QLT Inc. Mr. Adams has a diversified background, including positions in business development, strategic planning, sales and marketing, and mergers and acquisitions. He served as the President and CEO of enGene from Mar 2004 to April 2011. Mr. Adams holds a master's degree in international business from the University of South Carolina and a chemistry degree from the University of Southern Indiana.
Mr. Dunlop has over a decade of experience in evaluating early-stage technology companies. As founder and managing partner of MASA Life Science Ventures LP (MLSV), he leads the review, analysis, and management of the fund's investment candidates. He currently sits on the boards of directors of four early stage life science portfolio companies, including enGene, Inc. A former analyst with the Center for Strategic & International Studies in Washington, D.C., Mr. Dunlop has private equity and venture capital experience in Europe, the U.S. and Israel. Prior to joining MASA Inc as its director of new business ventures, Mr. Dunlop was an associate at New Vantage Group, manager of several early-stage venture capital funds in the Mid-Atlantic region. Mr. Dunlop holds an M.B.A. from Columbia Business School, a M.A. with honors in political economy from the University of Glasgow and an M.A. in International Relations from the Maxwell School of Citizenship and Public Affairs at Syracuse University. He is also a St. Andrews Society of New York Scholar.
Mr. Gargiulo is a NZX Advisor, a member of the Institute of Chartered Accountants of New Zealand and Chartered Secretaries of New Zealand. He was a partner in Neale Gargiulo Sharebroking, a brokerage and investment advice company, which in May of 2002 was acquired by First New Zealand Securities and later merged with First NZ Capital to become First NZ Capital Securities Limited, a NZX Accredited Firm of the New Zealand Exchange Limited. Mr. Gargiulo remains a director with the company. He is also the chairman and director of Aquae Minerales Ltd., an investment company involved in enGene's several rounds of financing.
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.
Mr. Erickson is a co-founder of the AXYS Group, a Sidney, B.C. based group of high technology companies. He founded and built Seastar Chemicals Inc. into one of the world's leading producers of high grade chemical reagents. Mr. Erickson is presently Chairman of the Board of Seastar. He has been an investor in enGene since 2007. Mr. Erickson has a personal interest in type 1 diabetes and he is an active philanthropist involved in funding type 1 diabetes research. He has been an early stage investor in numerous biotech and technology companies since retiring from day to day management responsibilities in 2003. Mr. Erickson is an analytical chemist and marine scientist by training.
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.
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.
COMPANY
01
COMPANY
enGene Inc., based in Vancouver, BC, has developed a highly flexible nucleotide (DNA and RNAi) delivery technology targeting mucosal tissues to treat numerous prevalent, chronic diseases via the induction or suppression of protein expression levels. Our platform technology has the ability to significantly impact diseases of mucosal tissues such as the gastrointestinal tract, lung and bladder as well as provide systemic release of proteins from the gut to treat diabetes, anemia, hemophilia and others.
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:
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.
The genesis of enGene's technology dates back to the 1970s when Dr. John C. Brown of UBC, a world-renowned researcher in gastrointestinal physiology, discovered the first incretin hormone called GIP (Glucose-dependent Insulinotropic Polypeptide) produced by K-cells in the gastrointestinal tract.
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.
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.
The three scientists co-founded enGene to translate this idea into a medical product. In the initial years of the company, enGene's scientists focused their efforts on developing a safe and robust method to deliver genetic material to cells in the gut. After the company's scientists had refined the nucleotide delivery system to successfully induce K-cells in the gut to make insulin, they started to expand the technology into a nucleotide delivery platform to treat diseases of the gut and other mucosal tissues such as the lung, bladder and uterus.
enGene's portfolio now encompasses a broad range of drug candidates drawing on its world-leading expertise in using biopolymers to deliver nucleotides.
enGene's portfolio now encompasses a broad range of drug candidates drawing on its world-leading expertise in using biopolymers to deliver nucleotides.
Since enGene's initial discoveries by the three founding scientists, our company has grown to include a solid core of scientific and research staff, whose areas of scientific expertise include diabetes and metabolism research, gastroenterology, cellular and molecular biology, gene delivery, and formulation and polymer chemistry. enGene deeply values its scientists, and views them as the core of future success, so we invest in their continual training and development.
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.
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's Management Team is also supported by two very impressive groups of individuals who are committed to the company's success. Our Board of Directors is comprised of industry-leading biopharmaceutical experts, and our Scientific and Clinical Advisory Board is composed of renowned experts in fields that complement enGene's research interests and development efforts.
From the beginning, enGene has made it a priority to secure key patents, and maintains vigorous monitoring and development of its intellectual property positions to ensure full capitalization of its assets.
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.
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.
B. Formulation of chitosan-based nanoparticles for delivering nucleotides to gut cells. enGene has identified and filed patents covering specific formulation parameters that allow for generation of nanoparticles that are stable and functional in delivering genes to the gut mucosal cells.
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.
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.
Inflammatory Bowel Disease (IBD)
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.
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.
enGene's EG-10 has the ability to overcome the shortcomings of existing biological therapies for IBD by providing localized delivery of therapeutic proteins to the diseased intestine, while limiting systemic distribution, thus having the potential to greatly reduce dose limiting side effects.
INFLAMATORY BOWEL DISEASE
DIABETES
Diabetes
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.
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.
Diabetes reduces quality of life, decreases life expectancy and strains healthcare resources. While there is a common misperception that diabetes can be easily managed by insulin injection, in fact, ideal glucose levels are rarely attainable in patients receiving exogenous insulin. As a result, diabetic patients remain at risk for the development of serious complications. On average, the expected life span of diabetic patients is shortened by about 16-17 years as compared to non-diabetic individuals. Approximately a third of all diabetics in North America require insulin injections to manage their disease, and the insulin-dependent population is estimated to be greater than six million.
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INFLAMATORY BOWEL DISEASE
DIABETES
In 2008, the global market for drugs to treat diabetes was $27.3 billion, and was led by insulin analogs, which accounted about $12 billion or 45% of the market. The worldwide market of human insulin products is expected to grow to $15 billion by 2012.
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.
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.
Since its introduction, Byetta™ has emerged as one of the top-selling non-insulin anti-diabetic drugs. The worldwide annual sales of Byetta™ reached $796.5 million in 2009. However, Byetta™ requires twice-daily subcutaneous injections, which could be prohibitive in promoting patient acceptance and compliance. There are several second-generation GLP-1 analogs in development, which require less frequent injections. With the introduction of newer and better GLP-1 products, the market for this class of anti-diabetes therapeutics is forecasted to exceed $6.0 billion by 2015.
INFLAMATORY BOWEL DISEASE
DIABETES
ANTHONY T. CHEUNG, PhD
Interim CEO/Co-FounderTIMOTHY J. KIEFFER, PhD
VP Research/Co-FounderERIC C. HSU, PhD
Sr. Director of Preclinical ResearchERIC C. HSU
Senior Director of Preclinical ResearchDr. 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, PhD
Interim CEO/Co-FounderTIMOTHY J. KIEFFER, PhD
VP Research/Co-FounderERIC C. HSU, PhD
Sr. Director of Preclinical ResearchANTHONY T. CHEUNG, PhD
Interim CEO/Co-FounderDr. 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.
He has received several awards and scholarships from the Juvenile Diabetes Research Foundation, American Diabetes Association, American Heart Association, Canadian Diabetes Association and the Alberta Heritage Foundation for Medical Research for his work in the field of diabetes. At enGene, Dr. Cheung has raised over $800,000 in non-dilutive funding from various governmental agencies and foundations, including the National Research Council of Canada.
Dr. Cheung has also been invited to speak at many international scientific and biotechnology conferences on topics related to gene therapy, diabetes and bio-entrepreneurism, and he is a regular guest lecturer at Simon Fraser MBA-management of technology program. Dr. Cheung also serves on the Bio-Industry Liaison Committee of the American Society for Gene and Cell Therapy and the British Columbia Student Biotechnology Network Advisory Board.
Dr. Cheung has also been invited to speak at many international scientific and biotechnology conferences on topics related to gene therapy, diabetes and bio-entrepreneurism, and he is a regular guest lecturer at Simon Fraser MBA-management of technology program. Dr. Cheung also serves on the Bio-Industry Liaison Committee of the American Society for Gene and Cell Therapy and the British Columbia Student Biotechnology Network Advisory Board.
ANTHONY T. CHEUNG, PhD
Interim CEO/Co-FounderTIMOTHY J. KIEFFER, PhD
VP Research/Co-FounderERIC C. HSU, PhD
Sr. Director of Preclinical ResearchTIMOTHY J. KIEFFER, PhD
VP Research/Co-FounderDr. Kieffer is enGene's Vice President of Research and a company co-founder. Dr. Kieffer is a professor in the departments of cellular and physiological sciences and surgery at the University of British Columbia. At UBC, Dr. Kieffer oversees the Laboratory of Molecular and Cellular Medicine, where his team conducts diabetes and obesity research complementary to that of enGene. He is also the head of the UBC Diabetes Research Group. He is a recognized expert in the field of gut endocrine hormones, and is a frequent lecturer on this topic at numerous international scientific conferences. He serves on the editorial board for Physiological Reviews and the Canadian Journal of Diabetes, and is frequently on review committees for several national and international diabetes funding agencies. His academic research programs are supported by the Canadian Institutes of Health Research, Networks of Centres of Excellence, the Canadian Diabetes Association, the Michael Smith Foundation for Health Research and the Juvenile Diabetes Research Foundation.
Dr. Kieffer received his doctorate degree in physiology from the UBC, where his research focused on gut K-cells. Dr. Kieffer demonstrated that the K-cell hormone, GIP, along with the related insulinotropic gut hormone, GLP-1, is rapidly degraded in the circulation by the enzyme dipeptidyl peptidase IV. Inhibitors of this enzyme are being developed to treat diabetes, the first of which to reach market is the Merck compound Januvia™. Other companies are generating analogs of GIP and GLP-1 that are resistant to degradation by DPP4, the first of these being the Amylin compound Byetta™. Following his PhD, Dr. Kieffer continued his research at Massachusetts General Hospital and Harvard Medical School in Boston where he gained expertise in molecular biology and continued to work in the field of diabetes. He was then recruited to the University of Alberta, Edmonton where he established his independent laboratory as an assistant professor in the Department of Medicine, before being recruited back to UBC.
ANTHONY T. CHEUNG, PhD
Interim CEO/Co-FounderTIMOTHY J. KIEFFER, PhD
VP Research/Co-FounderERIC C. HSU, PhD
Sr. Director of Preclinical ResearchANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorDr. 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.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverERIC A. ADAMS
Non-executive DirectorMr. Adams has more than twenty years of experience in pharmaceutical product development, commercialization and partnerships. He has held management positions in the pharmaceutical and biotechnology industry in North America and Europe with several companies, including Abbott Laboratories Inc. and Fresenius AG and QLT Inc. Mr. Adams has a diversified background, including positions in business development, strategic planning, sales and marketing, and mergers and acquisitions. He served as the President and CEO of enGene from Mar 2004 to April 2011. Mr. Adams holds a master's degree in international business from the University of South Carolina and a chemistry degree from the University of Southern Indiana.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverA. SINCLAIR DUNLOP
ObserverMr. Dunlop has over a decade of experience in evaluating early-stage technology companies. As founder and managing partner of MASA Life Science Ventures LP (MLSV), he leads the review, analysis, and management of the fund's investment candidates. He currently sits on the boards of directors of four early stage life science portfolio companies, including enGene, Inc. A former analyst with the Center for Strategic & International Studies in Washington, D.C., Mr. Dunlop has private equity and venture capital experience in Europe, the U.S. and Israel. Prior to joining MASA Inc as its director of new business ventures, Mr. Dunlop was an associate at New Vantage Group, manager of several early-stage venture capital funds in the Mid-Atlantic region. Mr. Dunlop holds an M.B.A. from Columbia Business School, a M.A. with honors in political economy from the University of Glasgow and an M.A. in International Relations from the Maxwell School of Citizenship and Public Affairs at Syracuse University. He is also a St. Andrews Society of New York Scholar.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverFRANCIS J. GARGIULO
Non Executive DirectorMr. Gargiulo is a NZX Advisor, a member of the Institute of Chartered Accountants of New Zealand and Chartered Secretaries of New Zealand. He was a partner in Neale Gargiulo Sharebroking, a brokerage and investment advice company, which in May of 2002 was acquired by First New Zealand Securities and later merged with First NZ Capital to become First NZ Capital Securities Limited, a NZX Accredited Firm of the New Zealand Exchange Limited. Mr. Gargiulo remains a director with the company. He is also the chairman and director of Aquae Minerales Ltd., an investment company involved in enGene's several rounds of financing.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverRichard M. Glickman
Non-Executive DirectorDr. 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.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverPAUL ERICKSON
Non-Executive DirectorMr. Erickson is a co-founder of the AXYS Group, a Sidney, B.C. based group of high technology companies. He founded and built Seastar Chemicals Inc. into one of the world's leading producers of high grade chemical reagents. Mr. Erickson is presently Chairman of the Board of Seastar. He has been an investor in enGene since 2007. Mr. Erickson has a personal interest in type 1 diabetes and he is an active philanthropist involved in funding type 1 diabetes research. He has been an early stage investor in numerous biotech and technology companies since retiring from day to day management responsibilities in 2003. Mr. Erickson is an analytical chemist and marine scientist by training.
ANTHONY T. CHEUNG
Interim CEO and Co-Founder, Executive DirectorRICHARD M. GLICKMAN
Non-Executive DirectorERIC A. ADAMS
Non-Executive DirectorFRANCIS J. GARGIULO
Non Executive DirectorPAUL ERICKSON
Non-Executive DirectorA. SINCLAIR DUNLOP
ObserverJOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardJOHN C. BROWN, PhD, DSc, FRSC
Dr. 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.JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardKEVAN JACOBSON, MD
Dr. 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.JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardJAY K. KOLLS, MD
Dr. 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).JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory Board>RUSSELL MUMPER, PhD
Dr. 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.
JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardCHRISTOPHER J. RHODES, PhD
Dr. 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.JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardPAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardDr. 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.
JOHN C. BROWN, PhD, DSc, FRSC
KEVAN JACOBSON, MD
JAY K. KOLLS, MD
RUSSELL MUMPER, PhD
CHRISTOPHER J. RHODES, PhD
PAUL D. ROBBINS, PhD
Chairman of the Scientific Advisory BoardBRIAN G. FEAGAN, MD, FRCPC
Dr. 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.BRIAN G. FEAGAN, MD, FRCPC
GEERT D'HAENS, MD, PhD
RICHARD N. FEDORAK, MD, FRCPC, FRCP (London)
SCOTT E. PLEVY, MD
GEERT D'HAENS, MD, PhD
Dr. 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.BRIAN G. FEAGAN, MD, FRCPC
GEERT D'HAENS, MD, PhD
RICHARD N. FEDORAK, MD, FRCPC, FRCP (London)
SCOTT E. PLEVY, MD
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.BRIAN G. FEAGAN, MD, FRCPC
GEERT D'HAENS, MD, PhD
RICHARD N. FEDORAK, MD, FRCPC, FRCP (London)
SCOTT E. PLEVY, MD
SCOTT E. PLEVY, MD
Dr. Plevy is an Associate Professor of Medicine, Microbiology and Immunology at the University of North Carolina School (UNC) of Medicine, Chapel Hill, USA. Prior to that, he was co-Director of the Inflammatory Bowel Disease Center at the University of Pittsburgh. Dr. Plevy also serves as Chair of the Education Committee for the Federation of Clinical Immunology Societies (FOCIS) and Director of the UNC FOCIS Center of Excellence. He is a current member of the National Scientific Advisory Committee and Chair of the Research Training Award Committee for the Crohn's and Colitis Foundation of America. Dr. Plevy is an elected member of the prestigious American Society for Clinical Investigation. He has been the principal investigator for numerous IBD clinical trials. His research interests include IBD, innate immunity, cytokine biology, and inflammation; and his research work is widely published in peer-reviewed journals. Dr. Plevy has served as editor and reviewers for several top ranking scientific and clinical journals, and has served on numerous NIH study sections.
02
TECHNOLOGY
02
TECHNOLOGY
02
TECHNOLOGY
enGene has developed an effective and highly flexible technology that delivers nucleotides (DNA and RNAi) to mucosal tissues to treat a wide variety of prevalent diseases by either inducing expression of therapeutic proteins or by suppressing the expression of harmful proteins.
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.
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.
The gut is the largest mucosal tissue in the body, and there is an abundance of specialized cells in the gut, called enteroendocrine cells, that have the natural ability to synthesize and release large quantities of proteins. enGene's technology has the ability to use the gut's natural protein production capability for therapeutic benefits. The easy accessibility of these gut cells makes them ideal candidates as internal factories to produce the needed therapeutic proteins for distribution within the body.
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enGene's technology modifies specific cell populations in the gut to provide protein drug release into the bloodstream in an intermittent (meal-regulated) or a continuous (steady-state) fashion. The company has successfully demonstrated both meal-dependent insulin secretion and steady-state protein secretion from gut mucosal cells in small and large animals. We are in the process of formulating our nucleotide delivery system for oral adminstration, allowing for direct delivery to the target cells. enGene's approach would revolutionize therapeutic protein delivery by eliminating the need for frequent needle injection, and improve patient compliance, safety and efficacy.
Impressive pre-clinical efficacy has resulted by inducing the gastro-
intestinal mucosal cells to express therapeutic proteins to treat two chronic diseases:
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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.
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For both the IBD and diabetes programs, we have already advanced beyond the discovery stage to demonstrate their therapeutic potential in various small and large animal models. We have also held discussions with various regulatory authorities regarding the pre-clinical development plan, and are poised to advance our product development into human clinical trials.
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.
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.
Inflammatory bowel disease (IBD) is a common autoimmune disorder with unknown cause. Patients with IBD exhibit tissue inflammation in the wall of their intestine, and experience a range of symptoms including diarrhea, abdominal pain, bloody stools and malabsorption, often resulting in weight loss. Although IBD is a serious and prevalent disease affecting over a million and a half North Americans and four million people worldwide, there is currently no effective cure.
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
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
Another limitation of this class of protein drug is the tendency of the body to develop an immune reaction to the drug, leading to neutralization of its effects. Notably, about 17-20% of IBD patients on Remicade® developed resistance to the drug. The effectiveness of biologics in treating IBD is also limited by their low bioavailability in the gut due to the route of delivery (intravenous or subcutaneous injections). High doses are required to increase the local drug concentration in the affected gut tissues, which increases the risk for systemic toxicity.
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enGene's therapy, called EG-10, addresses these issues by concentrating the delivery of interleukin-10 (IL-10) to the site of disease in patients with IBD. IL-10 is a potent anti-inflammatory protein which exists naturally in the body, and plays a dominant role in the induction and maintenance of immune tolerance in many autoimmune diseases. Although previous large-scale clinical trials conducted by a pharmaceutical company have demonstrated some therapeutic efficacy in humans with IBD using low doses of injectable IL-10, its effectiveness is limited by excessive systemic adverse drug effects at higher doses. The short half-life of recombinant IL-10 in the bloodstream is also a significant limiting factor for its clinical success. EG-10 is designed to specifically address the disadvantages associated with the use of injectable IL-10. Specifically, EG-10 is aimed at maximizing its local therapeutic effects in the gastrointestinal tract while limiting systemic exposure of IL-10.
We have developed a proprietary technology that delivers DNA that encodes the IL-10 protein directly to the colon. EG-10 turns cells in gut lining into factories to make IL-10. In this way, EG-10 achieves sufficient IL-10 concentration and bioavailability in the intestinal tract, while minimizing its distribution in the systemic circulatation, and therefore avoids many unwanted systemic side effects.
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 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 was founded originally to develop a better treatment for people with diabetes. Our scientific founders continue to be astonished that more than 85 years after the discovery of insulin, this drug is still delivered by injections despite the many limitations of this approach. The challenge was to find a more effective way to treat the disease.
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.
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.
Insulin is normally produced in beta-cells located in the pancreas, but in individuals with diabetes, the beta-cells have either been destroyed or have lost the ability to produce enough insulin to meet the body's demands. K-cells, which are found in the gut, produce and secrete a hormone named GIP in response to the amount of glucose consumed. enGene has proven that K-cells, because of their structural and functional similiarities with insulin-producing beta-cells, can be genetically re-programmed to synthesize and secrete insulin similar to the beta cells in the pancreas.
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Our technology effectively coaxes gut K-cells to produce insulin, which in turn allows the body to metabolize sugar. What's more, EG-02's ability to regenerate automatic insulin production eliminates the short- and long-term complications of dosing guess-work and exogenous insulin therapy, be it injected, inhaled, or delivered through pumps. Additionally, it offers an alternative to islet cell transplantation, xenotransplants and stem cell therapies, all of which are limited by inadequate cell sources, manufacturing challenges and a requirement for chronic immunosuppression.
Our EG-02 technology is in advanced pre-clinical development, with extensive data supporting its therapeutic potential, its feasibility and its efficacy in numerous small and large animal models. By enabling the body to produce and release insulin in the proper quantities and time to effectively regulate sugar levels, our technology has the potential to provide an important alternative to insulin injections for people with diabetes.
What Is Diabetes?
What Is Diabetes?
What Is Diabetes?
What Is Diabetes?
siRNA or small interfering RNA is an exciting new class of therapeutics that acts by inhibiting the expression of specific genes. Thus, it offers the possibility to disrupt the production of various disease-causing proteins. The discovery of siRNA-mediated gene silencing is widely considered to be one of the most important recent breakthroughs in the field of medicine with the potential to change how diseases are treated.
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.
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.
enGene's proprietary process for manufacturing highly concentrated chitosan-siRNA nanoparticles at a commercially relevant scale will greatly enhance the development and enablement of siRNA as a viable pharmaceutical product. We are currently testing novel formulations with multiple partners to optimize siRNA delivery to specific tissues.
enGene's nucleotide delivery platform is highly versatile and flexible. Our technology currently enables the delivery of nucleotides to various mucosal tissues throughout the body. By designing the nucleotide sequence and targeting the specific tissue, specific pharmacokinetic profiles can be achieved, enabling either steady-state, or intermittent (meal-dependent) production and release of proteins into the surrounding tissues and bloodstream.
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.
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.
enGene is optimizing our pipeline expansion efforts by partnering new opportunities with academic and industry leaders.
enGene's Pipeline
enGene's Pipeline (click to enlarge)
enGene's Pipeline
enGene's Pipeline (click to enlarge)
03
PRESS/NEWS
03
View Interview
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PRESS/NEWS
03
PRESS/NEWS
January 24, 2012
World-leading Inflammatory Bowel Disease Clinical Investigators Join enGene's Newly Established Clinical Advisory Board (PDF)October 19, 2011
enGene, Inc. appoints Dr. Richard M. Glickman to the company's Board of Directors and announces changes to its Board composition (PDF)February 2, 2011
enGene, Inc. CEO to Present at BioPartnering North America Conference (PDF)December 6, 2010
enGene, Inc. CSO to Present Key Pre-clinical Data on EG-10 for Treating Inflammatory Bowel Disease (PDF)November 2, 2010
enGene CEO Interviewed by BioTuesday (PDF)View Interview
September 1, 2010
enGene, Inc. Adds Leading Nanomedicine Expert to Scientific Advisory Board (PDF)June 10, 2009
enGene, Inc. Receives NRC-IRAP Contribution, Initiates Convertible Note Financing (PDF)June 30, 2008
Dr. John C. Brown to Join enGene, Inc. Scientific Advisory Board (PDF)June 15, 2008
enGene, Inc. CSO to Present at Key International Conferences: BIO and Children with Diabetes (PDF)June 10, 2008
enGene, Inc. Adds Leading Gastroenterology Experts as Scientific Advisors (PDF)March 17, 2008
enGene, Inc. Completes US$6.4M Series A Financing (PDF)March 10, 2008
enGene, Inc. Announces Issuance of Core US Patent (PDF)February 7, 2008
enGene, Inc. Announces Changes to the Board of Directors (PDF)more >
October 17, 2007
enGene, Inc. Introduces New GEMS™ Non-Viral Gene Delivery Technology and Initiates Series A Financing (PDF)June 1, 2007
enGene, Inc. to Present at the American Society of Gene Therapy (PDF)October 17, 2006
enGene, Inc. Introduces New GEMS™ Non-Viral Gene Delivery Technology and Initiates Series A Financing (PDF)October 3, 2006
enGene, Inc. Adds Leading Diabetes and Gene Therapy Experts as Scientific Advisors (PDF)March 17, 2006
enGene to Present at the Invest Northwest CEO and Investor Forum March 21-22, 2005 (PDF)March 13, 2006
enGene to be featured on CEO Clips on The Biography Channel (PDF)October 28, 2005
enGene, Inc. Named Recipient of The 2005 Excellence In Research of the Year Award by Frost & Sullivan (PDF)June 22, 2005
enGene, Inc. to Present at Private Equity 2005: Emerging Growth & Venture Forum (PDF)June 14, 2005
enGene, Inc. to Present at Bio 2005 Annual International Convention (PDF)May 26, 2005
enGene, Inc. Selected as a 2005 Venture All Stars' Top 50 Emerging Growth Company (PDF)May 5, 2005
enGene, Inc. Co-Founder to be Interviewed On Canada's Top-Rated Financial Radio Broadcast (PDF)April 22, 2005
enGene, Inc. to Present at the Invest Northwest Ceo and Investor Forum April 26 - 27, 2005 (PDF)more >
November 16, 2004
enGene, Inc. Appoints R. Hector Mackay-Dunn and L. Jack Wood to its Board of Directors (PDF)October 4, 2004
enGene, Inc. to Present at Biocontact Quebec 2004 (PDF)September 28, 2004
enGene, Inc. to Present at Bio Emerging Company Investor Forum (PDF)March 15, 2004
enGene, Inc. Announces Eric A. Adams Joins as Chief Executive Officer and President (PDF)January 16, 2004
enGene, Inc. Awarded $350,000 from NRC-IRAP (PDF)April 1, 2003
enGene's Diabetes Therapy Received Independent Positive Reviews in Several Scientific Journals (PDF)July 1, 2002
Lad Burgin Joins enGene Board of Directors (PDF)July 1, 2002
enGene Announces Addition of Key Scientists (PDF)March 1, 2002
enGene Establishes Eminent Scientific Advisory Board (PDF)February 16, 2002
enGene Licenses Key Gut Gene Therapy Technology from Baylor College of Medicine (PDF)December 17, 2001
enGene Announces Establishment of New Corporate Headquarters in Vancouver, British ColumbiaAugust 15, 2001
enGene Raises $2.1 Million in Seed-Round Private Financing (PDF)DELIVERING
THE PROMISE
OF MOLECULAR
THERAPEUTICS
