Stem Cells Sweden A key area for stem

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Stem Cells Sweden A key area for stem cell research and investment 06 November

Stem Cells Sweden A key area for stem cell research and investment 06 November 2020 www. isa. se 1

A major new healthcare sector Stem cell research with: ¡potential to transform disease treatment,

A major new healthcare sector Stem cell research with: ¡potential to transform disease treatment, reduce costs to society, and enhance quality of life for millions of patients. ¡scope for significant business opportunities, with new directions for industry innovation and product development. A unique combination of scientific know-how and commercialization capabilities is enabling Sweden to become a world force in the field. 06 November 2020 www. isa. se 2

Business opportunities in Sweden ¡ Leading stem cell researchers and research institutes. ¡ Global

Business opportunities in Sweden ¡ Leading stem cell researchers and research institutes. ¡ Global position in culturing embryonic stem cell lines. ¡ Favorable political and ethical climate. ¡ Relatively easy to capitalize on innovations; ”teachers exemption” and technology transfer units ¡ Sophisticated and specialized domestic venture capital industry. “Sweden has emerged as a key area for stem cell research and investment. ” Elliott Davis, General Partner, Next Wave Funds 06 November 2020 www. isa. se 3

Current market potential ¡ Licensing of stem cell lines. ¡ Proliferation and characterization of

Current market potential ¡ Licensing of stem cell lines. ¡ Proliferation and characterization of specialized lines. ¡ Commercialization of media that direct cell differentiation. ¡ Diagnostic methods and techniques ¡ Therapy development. A number of Swedish companies have been founded to capture business opportunities in stem cell research. 06 November 2020 www. isa. se 4

Good reasons to choose Sweden for stem cell-based R&D ¡ Source of breakthrough research

Good reasons to choose Sweden for stem cell-based R&D ¡ Source of breakthrough research achievements ¡ Holds a large share of human embryonic stem cell lines eligible for U. S. public funding. ¡ The legislative environment supports all areas of stem cell research. ¡ Has more than 30 stem cell research groups and 300 people at nine Swedish institutions involved. ¡ Stem cell clusters are emerging at three prominent life sciences sites. ¡ Capability to cover whole value chain for commercialization of stem cell research. 06 November 2020 www. isa. se 5

Stem cells – a definition ¡ Undifferentiated cells that give rise to all of

Stem cells – a definition ¡ Undifferentiated cells that give rise to all of the body’s cells and organs. Three sources of stem cells: embryonic, adult and fetal. Research performed on humans and in animal models. ¡ Capacity for self-renewal: through repeated cell division, every stem cell can form two identical copies of itself ¡ … and multipotency: stem cells can form progeny that can differentiate, i. e. develop into one of the different types of cells that comprise the living organism ¡ In principle, each one of the human body’s 200 different cell types can be cultured from a single immature stem cell. ¡ Research performed on different tissue types: Hematopoietic (blood); Neural (brain); Mesenchymal (connective tissue, muscles, blood vessels) 06 November 2020 www. isa. se 6

From stem cell to full-fledged body cell 06 November 2020 www. isa. se 7

From stem cell to full-fledged body cell 06 November 2020 www. isa. se 7

Potential to cure a variety of diseases ¡ Blood cells Cancer, immunodeficiencies, inherited blood,

Potential to cure a variety of diseases ¡ Blood cells Cancer, immunodeficiencies, inherited blood, diseases, leukaemia ¡ Bone cells Osteoporosis ¡ Cartilage cells Osteoarthritis ¡ Heart muscle cells Heart attacks, congestive heart failure ¡ Insulin-producing cells Diabetes ¡ Liver cells Hepatitis, cirrhosis ¡ Nerve cells Stroke, Parkinson’s disease, Alzheimer’s disease, spinal cord injury, multiple sclerosis ¡ Retinal cells Macular degeneration ¡ Skeletal muscle cells Muscular dystrophy ¡ Skin cells burns, wound healing Two therapeutic approaches have been distinguished: • Cellular therapy (i. e. cell transplantation) • Pharmaceutical approach (signaling substances) 06 November 2020 www. isa. se 8

High quality of research (1) Source: Boston Consulting Group, “Swedish Brain Power”, 2001 06

High quality of research (1) Source: Boston Consulting Group, “Swedish Brain Power”, 2001 06 November 2020 www. isa. se 9

High quality of research (2) The graph shows individual countries’ share of publications in

High quality of research (2) The graph shows individual countries’ share of publications in scientific journals per capita. Publications in 24 scientific journals were studied and classified according to each journal’s impact factor. Source: Boston Consulting Group, “Swedish Brain Power”, 2001 06 November 2020 www. isa. se 10

Large commercial potential High-potential diagnoses in stem cell research Global economic burden for society

Large commercial potential High-potential diagnoses in stem cell research Global economic burden for society (BUSD) (1) Aggregate of CNS diagnoses included in graph. (2) Based on osteoarthrosis costs. (3) Assumes that liver failure costs are maximum of 1/3 of all gastroenterology costs. Note: Year 2000 market figures Source: Boston Consulting Group, “Swedish Brain Power”, 2001 06 November 2020 www. isa. se 11

Sweden possesses the required cross-functional capabilities (1) Includes e. g. , hematologists, cardiologists, transplant

Sweden possesses the required cross-functional capabilities (1) Includes e. g. , hematologists, cardiologists, transplant surgeons, orthopedics. Source: Adapted from Boston Consulting Group, “Swedish Brain Power”, 2001 06 November 2020 www. isa. se 12

Breakthroughs by Swedish researchers ¡ First clinical trials of fetal neural cell grafting in

Breakthroughs by Swedish researchers ¡ First clinical trials of fetal neural cell grafting in patients with Parkinson’s disease (Anders Björklund and Olle Lindvall, 1987) ¡ Discovered the nesting gene, the most commonly used marker for neural stem cells (Urban Lendahl, 1990) ¡ First to demonstrate that the human brain contains cells with stem cell-like properties (Peter Eriksson, 1998) ¡ First to identify adult neural stem cells capable of forming new neural stem cells (Jonas Frisén et al, 1999) ¡ First to identify adult stem cells’ potential to generate a variety of cells for other organs (Jonas Frisén et al, 2000) 06 November 2020 www. isa. se 13

Commercialization resources in Sweden Basic research • Funding • Key competences • Key technologies

Commercialization resources in Sweden Basic research • Funding • Key competences • Key technologies • International and domestic networks with leading research groups • Positive bioethical and regulatory environment Clinical development • Good animal disease models for proof-of-concept • High integration of basic and clinical research • Multidisciplinary groups of relevant specialists with co-location/closeness • Well-designed studies • Excellent conditions for clinical research Commercialization • Venture capital and management skills • Technology transfer and spin-offs infrastructure • Cluster of companies; biotech, med-tech, diagnostics, big pharma • Closeness including shared core facilities Source: Boston Consulting Group, “Swedish Brain Power”, 2001 06 November 2020 www. isa. se 14

Major sites for stem cell research ¡ Karolinska Institutet, Stockholm § § § Leading

Major sites for stem cell research ¡ Karolinska Institutet, Stockholm § § § Leading position in basic research on adult stem cells, especially in neurology area. Very strong in developmental neurobiology and cellular biology. Good IVF clinic and leading position in embryonic stem cell lines development. Strong stem cell transplantation unit. Strong developmental biology groups in CNS, pancreas and hematology. ¡ Sahlgrenska Academy, Göteborg § § § 06 November 2020 www. sahlgrenska. gu. se Leading position in establishing embryonic cell lines. Strong IVF program. Leading position in research on adult neurogenesis and stem cell neurobiology. Strong developmental biology groups in pancreas, blood vessel formation, and cellular biology. Leading position in developing FDA approved, (GMP) certified cell-based transplantation therapy (cartilage repair). ¡ Lund University, Lund § § www. ki. se www. lu. se Leading position in clinical applications of cell therapy in neurology area. Good stem cell biology in hematopoetic area and gene therapy vectors. www. isa. se 15

Examples of stem cell research projects (1) Chalmers University of Technology, Göteborg § §

Examples of stem cell research projects (1) Chalmers University of Technology, Göteborg § § Julie Gold: Methods to steer differentiation of stem cells at specific spatial locations using cell surface interactions. Tomas Gustavsson: Development of advanced image analysis systems to study cell division and differentiation. Sahlgrenska Academy, Göteborg § Peter Eriksson: Broad studies on the molecular mechanisms involved in neural stem cell proliferation and differentiation and their use in therapeutic strategies. § Lars Hamberger/Charles Hanson Improving culture methods for blastocyst development to secure optimized stem cell material for further identification and analysis. § Anders Lindahl: Development, growth and regeneration of hyaline cartilage. § Henrik Semb: Definition of optimal cultivation conditions for human embryonic stem cells and continuous generation of such lines. University of Lund § Anders Björklund: Neural stem cells and immortalization of neural stem cell lines. Development of cells for transplantation. § Sten Eirik Jacobsen: Hematopoietic stem cells and molecular mechanisms governing stem cell differentiation. § Stefan Karlsson: Research program studying the genetic control of hematopoietic stem cell proliferation. § Olle Lindvall: Research program for transplantation of neural stem cells, for instance to regain function after Parkinson’s disease and stroke. 06 November 2020 www. isa. se 16

Examples of stem cell research projects (2) Karolinska Institutet, Stockholm § Ernest Arenas: Identification

Examples of stem cell research projects (2) Karolinska Institutet, Stockholm § Ernest Arenas: Identification and characterization of signals required to instruct and promote the survival of midbrain dopaminergic (DA) neurons. § Patrik Ernfors: Neural crest stem cells and regulation of differentiation and functionality of peripheral sensory neurons. § Jonas Frisén: Broad neurobiological research studying the physiological importance of nerve cell development and regulating mechanisms. § Outi Hovatta/Lars Ährlund-Richter: Finding optimal cultivation conditions for human embryonic stem cells with particular regard for potential clinical applications. § Katarina Le Blanc: Human mesenchymal studies of stem cells from bone marrow of adult individuals and from fetal livers. § Urban Lendahl: Gene regulation in CNS stem cells, particularly in relation to the Notch signaling pathway. § Thomas Perlman: How signals from nuclear receptors affect the development and survival of certain neural stem cell types. § Olle Ringdén: Allogenic bone marrow or hematopoietic stem cell transplantation in the treatment of human blood disease, particularly leukemia. University of Linköping § Per Fagerholm: Effect of corneal stem cell transplantation to treat various forms of corneal damage. Strong clinical profile. 06 November 2020 www. isa. se 17

Examples of stem cell research projects (3) University of Stockholm § Barbara Cannon/Jan Nedergaard:

Examples of stem cell research projects (3) University of Stockholm § Barbara Cannon/Jan Nedergaard: Study of brown fat tissue, with particular regard to the regulatory functions of noradrenaline. § Anders Jakobsson: Homologic recombination in embryonal mouse stem cells to produce mice with genetic mutations. University of Umeå § Leif Carlsson: Clarification of molecular mechanisms for immortalizing hematopoietic stem cells and development of systems for in-vitro cultivation of hematopoietic stem cells for clinical purposes. Swedish University of Agricultural Sciences, Uppsala § Eva Hellmén: Organogenesis of lymph nodes in relation to varying breast tumor phenotypes in differing species. University of Uppsala ¡ Michael Welsh: The role of the endothelium in pancreatic beta cell differentiation. Source: Swedish Research Council, “A Survey on Stem Cell Research in Sweden”, 2002 06 November 2020 www. isa. se 18

Favorable Swedish legislative climate Guidelines for ethical review of human stem cell research applications

Favorable Swedish legislative climate Guidelines for ethical review of human stem cell research applications ¡ Stem cells from adults YES ¡ Stem cells from umbilical-cord blood after childbirth YES ¡ Stem cells from aborted foetuses before week 14 YES ¡ Stem cells from embryos which remain after in vitro fertilization YES ¡ Creation of embryos from eggs and sperm solely for research purposes NO ¡ Somatic cell nuclear transfer (therapeutic cloning) YES ”While many countries are hampered by the ethical debate to limit embryonic research, Sweden has supported the development of potential benefits instead. ” Elliott B. Davis, Next Wave Funds 06 November 2020 www. isa. se 19

Making stem cell research a business ¡ Cell Therapeutics Scandinavia, Göteborg therapies for human

Making stem cell research a business ¡ Cell Therapeutics Scandinavia, Göteborg therapies for human diseases and other applications of stem cell technologies. ¡ Neuronova, Stockholm technologies to proliferate adult neural stem cells in culture and to differentiate them into dopaminergic neurons, for transplantation use w/ Parkinson’s disease. ¡ Ns. Gene, Copenhagen (Stockholm/Lund) products to treat neurological diseases, based on cell and gene therapy ¡ Vitrolife, Göteborg products for assisted reproduction and transplantation. Target areas include neurodegenerative disorders, degenerative joint diseases, cardiovascular diseases, and diabetes. 06 November 2020 www. isa. se 20

ISA – your business facilitator ¡ Dedicated life sciences teams in the U. S,

ISA – your business facilitator ¡ Dedicated life sciences teams in the U. S, Europe and Asia. ¡ For further information, please contact Lars Vedin M. D. Head of Life & Bio Sciences Direct phone: +46 8 402 78 33 Mobile phone: +46 707 28 73 90 lars. vedin@isa. se www. isa. se/lifesciences. htm 06 November 2020 www. isa. se 21