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The Development of Microbiome-based Probiotics in Prevention and Treatment of Obesity
- 2. History • 2008 The fine-scale and complex architecture of human copy-number variation. - The American Journal of Human Genetics 2008 • 2009 A highly annotated whole-genome sequence of a Korean individual - Nature 2009 • 2010 Discovery of common Asian copy number variants using integrated high-resolution array CGH and massively parallel DNA sequencing - Nature Genetics 2010 • 2011 Extensive genomic and transcriptional diversity identified through massively parallel DNA and RNA sequencing of eighteen Korean individuals - Nature Genetics 2011 • 2013 NIH Human Microbiome Project • 2015 Korean Government Immuno-oncology Initiatives • Sept. 2015 Genome and Company Set up • Jan. 2016 Initial Investment from Venture Capital, 1M$ • Feb. 2016 Genome and Company Research Institute set up • Oct. 2016 Korean Government Tech Incubator Program awarded, 0.6M$ • ~ Dec. 2016 Additional Investment from Venture Capital, about 4.5M$ Immuno-oncologyResearch MicrobiomeResearch HumanGenomicsMedicineResearch
- 3. Pipeline * GRAS: Generally regarded as safe Pipeline 2016 2017 20182015 2016년 11월 현재 Dietary Supplement s Obesity, Diabetes (GRAS* strain) Product planning Effect Test Clinical research Product launch GRAS strain selected Obesity, Diabetes Sampling Pre-R&D Meta genomic analysis Product planning Effect Test Clinical research Cosmetic Acne Atopic dermatitis Meta genomic analysis Sampling Pre-R&D Effect Test Product launchClinical research Short term Commercial Project Immuno- oncology Immuno-oncology (GRAS* strain) Product planning sampling Clinical research GRAS strain selected Lung cancer sampling Pre-R&D Effect Test Meta genomic analysis Clinical research Colorectal cancer Sampling Effect TestMeta genomic analysis Clinical research Stomach cancer sampling Pre-R&D Effect Test Meta genomic analysis Clinical research Breast cancer sampling Pre-R&D Effect Test Meta genomic analysis Clinical research Pancreatic cancer Sampling Pre-R&D Effect Test Meta genomic analysis Clinical research Long term Potential Project Meta genomic analysis Sampling Pre-R&D Effect Test Product planning Clinical research Medicine IVF (In Vitro Fertilization) Pilot Project Product planning Product planning Product planning Product planning Product planning Product planning
- 4. Business Roadmap 2015, 2016 • Company Set up • Established partnership with Korea major hospital; SNUH, SMC, AMC, GACHON, NCC, CHA Hosp. • Series A investment 2017 • Launch probiotics product to treat obesity and diabetes, based on GRAS • Clinical research on probiotics to treat obesity and diabetes • Clinical research on therapeutic cosmeceuticals to treat acne and atopic dermatitis 2018 • Licensing out 1 case • Launch therapeutic cosmeceutical products to treat acne and atopic dermatitis • Market expansion for obesity and diabetes probiotics • Clinical research on supplement of immuno-oncologic cancer drug 2019 • Launch supplement of immuno- oncologic cancer drug • Licensing out 3 cases • Asian Microbiome Flagship Company • Product development based on scientific data • Licensing out • Most reliable partner for global pharmaceuticals or nutrition companies regarding Asian market penetration Genome & Company, Vision 2018 KOSDAQ IPO
- 5. Paradigm shift of Cancer therapy Limitation Control mechanism Before 2000 1st Generation: Chemotherapy • Harmful for normal cell Serious side effect • Attack fast growing cancer cell Attack Cancer cell / Normal cell Kills Cancer cell & Normal cell 2nd Generation: Targeted therapy 2000~ present • Side effect mitigation • Tolerance to drug / Recurrence • Attack mutation of cancer cell Attack Kills Cancer cell 3rd Generation: Immunotherapy 2010 ~ present • Less effect in case of low immunity • Activate immune function to attack cancer cell Enhance immune function Kills Cancer cell Immune cell 4th Generation: Immunotherapy & Onco-probiotics Present~ • Activate immune function targeting cancer cell • Activate immune function to reduce cancer resistance against immunooncology drugs Immune cell Kills Cancer cell Maximize Immune function Microbiota Activation Activation
- 6. Microbiome boosts effectiveness of Immunotherapy Days Survivalrates Medical benefits Medical benefits Effectiveness of current therapies Targeted therapy and Immunotherapy are mutually complementary Target therapy Days Medical benefits Survivalrates Effectiveness of immunotherapy utilizing Microbiome Immunotherapy with microbiome is expected to boost effectiveness of cancer therapy
- 7. Market expectation of Immunotherapy Source: (Left) Datamonitor Healthcare; company-reported information (global) (Right) CenterWatch, FDA, clinicaltrials.gov, IMS R&D LifeCycle, IMSCG Analysis; *NME: New Molecular Entity 0 2,000 4,000 6,000 8,000 10,000 12,000 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 OPDIVO KEYTRUDA MEDI-4736 RG7446 PD-1/PD-L1 Inhibitors revenue (2014–2023, E) $ Mil 0 5 10 15 20 25 30 35 40 2014 2015 2016 2017 2018 2019 2020 2021 4 8 7 7 13 19 15 34 No of immunotherapy NME*, expected to be launched in market 개
- 8. Probiotics market grows fast in Korea: CAGR 38.7% Source: Nielsen Korea Probiotics market size 0 200 400 600 800 1,000 1,200 1,400 1,600 2011 2012 2013 2014 2015 억원 Recently, average annual growth of the probiotics market is 38% 140 100 80 60 40 0 bil 120 20 “Ildong acquired a patent with nattokinase producing strain ‘Bacillus subtilis IDCC 9204’ extracted from natto” 2013. 03. 13 “CJ Cheil Jedang launched health functional food which improves itching sense, with lactobacillus plantarum CJLP133, extracted from kimchi. 2014. 09. 30 Probiotics products Pharmaceutical
- 9. Product Positioning: “identify the beneficial bacteria through genome analysis” GNC analysis of launched products at 2013~2015 5000 4000 3000 2000 1000 0 4500 3500 2500 1500 500 Price (won/unit) Products in market Daesang Well life: Lactobacillus probiotics Lactobacillus (Extracted from kimchi) Cellbiotech: duolac • Lactobacillus (Traditional Fermented Foods, Extracted from the feces newborn) LG life sciences: professional bio balance • Lactobacillus 5 strains • Bifidus 4 strains • Thermophilus 1 strains ORGA Whole foods: Full vita mixed lactobacillus • Lactobacillus 4 strains • Bifidus 4 strains Genus level Species level Strain level Genome level Daesang Well life : Ruteri probiotics, zinc • Lactobacillus reuteri Cenovis: probiotics • Lactobacillus plantarum 299v CJ Cheil Jedang: Lactic acid skin CJLP133 • Lactobacillus plantarum CJLP133 Bacteria NaMoo: VSL3 • Lactobacillus 4 strains • Bifidus 3 strains • Streptococcus 1 strains
- 10. Caucasian vs Asian * Nature, doi:10.1038/nature12198 http://www.nature.com/nature/journal/v498/n7452/extref/nature12198-s1.pdf “In the case of acne, most Caucasian acne patients have non-inflammatory type, while Asians have inflammatory type.“ “It is highly probable that different bacteria act between Caucasian and Asian.” - Wonwoo Choi, MD, Dermatologist Acne: Caucasian vs Asian For diabetic patients, Swedish and Chinese acne patients show different composition of skin microbiome. - Nature in 2013* Diabetes mellitus: Caucasian vs Asian
- 11. TumorT CellNK CellAg Primed DCs HSC Currently Common Mouse model Mouse with mice’ tumor cell, immunocyte Tumor T Cell NK Cell Ag Primed DCs HSC Humanized Mouse Avatar model Mouse with humans’ tumor cell, immunocyte More humanized experimental environment Humanized Mouse Avatar
- 12. Team ScienceBusiness Jisoo Pae (CEO) • Seoul National University, College of Medicine, MD • Seoul National University Hospital, Dept. of Neuropsychiatry, Psychiatrist • Duke Univ., MBA • Bain & Company, Consultant • MSD, External Affair / Business Development, Associate Director Hansoo Park (CTO) • Seoul National University, College of Medicine, MD • Seoul National University Hospital, Biochemistry, PhD • Harvard Medical School, Post Doc • The Jackson Laboratory, Research Associate Sophie Won • Yonsei University, Buiness, BA • USC, MBA • AT Kearney Subject Matter Expert • LG Chem / Electronics general manager • IBM/Accenture Consultant Deukchae Na • Yonsei University, Medical Science, PhD • Asan Medical Center, Dana-Farber laboratory / Seoul National University Hospital, Cancer lab, Senior researcher • Ewha Womans University Research Assistant Professor Changho Park • Seoul National University Hospital, Biochemistry, PhD • Seoul National University, Medical research, Post Doc Choa An • Tokyo University Marine Science & Technology, PhD • Seoul National University, Research Assistant Professor Jinyoung Sohn • Ulsan University, Medical Science, PhD • Olipass In vivo pharmacology (Animal Test) Wonduck Kim • University of Georgia, Microbiology, PhD • Ohio State University (Post doc) • Chosun University Research Assistant Professor • KIOST, Chief researcher Sujin Hwang • Seoul National University, Pharmacy, BA • Samsung Medical Center, Pharmacist • Pfizer, MR • Duke, MBA • AstraZeneca brand manager • Eli Lilly, Marketing, BD, Alliance manager
- 13. R&D Partners IVF (In Vitro Fertilization)Genomic Medicine, In Vivo Test Dermatology (Acne)Obesity Therapeutic Supplements Immuno–oncology Pf. Sehoon Lee, MD, PhD Pf. Wonsuk Lee, MD, PhDPf. Seockah Im, MD, PhD Pf. Sangmyung Woo, MD, PhD Pf. Belong Cho, MD, PhD Pf. JinHo Park, MD, PhD Pf. Sungsoon Hwang Fang, PhD Wonwoo Choi, MD, PhD Pf. JongIl Kim, MD, PhD • Laboratory of Genomic Medicine • Seoul National University Pf. JeKyung Seong, PhD • Laboratory of developmental Biology and genomics • Seoul National University Pf. Hogil Huh • Institute of Integrated Technology, GIST • Seoul National University College of Agriculture and life science PhD Pf. Youngsok Choi • Biotechnology • CHA University College of Medicine • Internal Medicines, Hemato-Oncology • Samsung Seoul Hospital • General Surgery • Gachon University Gil hospital • Internal Medicins, Hemato-Oncology • Seoul National University Hospital • Internal Medicine • National Cancer Center • Family Medicine • Seoul National University Hospital • Lab of Human Metabolic • Sejong University • Well’s Dermatologic Clinic • Family Medicine • Seoul National University Hospital