Presented at the 4th Microbiome R&D and Business Collaboration Forum: Europe. To find out more, visit: www.global-engage.com
Jisoo Pae, CEO of Genome and Company, discusses the development of novel therapeutics in obesity and cancer and gives an overview of their microbiome pipeline.
The Development of Microbiome-based Probiotics in Prevention and Treatment of Obesity
1.
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