1. Company Overview
Presentation is prepared for Skolkovo Foundation
2012

2. Key Facts
• Company status Private Russian biotech company
• Founded 2010
• Our mission Developing and marketing innovative biopharmaceutical drugs
targeting the most prevalent and dangerous systemic diseases
• Main focus Oncology
• Technology platform Cell-penetrating peptides (CPP)
• Investors Maxwell Biotech Venture Fund
• Partners  Maxwell Biotech Group
 RVC
 Skolkovo
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3. Pipeline
Further
development
Stage Lead
Screening Preclinical Phase 1 Phase 2a
Product optimization
MM-D37K Colorectal cancer
Colorectal cancer
MM-D37K Other indications
Other indications
Novel peptides
2012 goals:
• Receiving clinical trial permission for Phase 1/2a on patients with gastrointestinal cancers;
• R&D activities — in silico, in vitro and in vivo screening and optimization
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4. MM-D37K Summary
• Product: chimeric peptide based on CPP platform technology for colorectal cancer (CRC)
treatment with possible expansion to other cancer treatment indications;
• Mechanism of action: activates apoptosis in cancer cells using cycline-dependent kinase
inhibition mechanism;
• Market potential:
 Global CRC market ~ $7 billion with unmet clinical need to decrease toxicity of current
chemotherapy as well as to prolongate life of patients with metastatic forms of cancer;
 Russian CRC market- $60 million;
• Competitive advantages: low peptide toxicity together with additive/synergiс effect with
traditional chemotherapeutic agents;
• In vitro and in vivo activity demonstrated in different tumor types;
• Development status: preparing regulatory registration package to initiate clinical trials on
patients with gastric cancers.
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5. Market Overview (CRC)
Colorectal cancer is a type of cancer characterized by neoplasia in the colon, rectum, or vermiform appendix
CRC is one of the leading causes of all cancer deaths worldwide and accounts for more than 600 000 deaths
every year (WHO, 2011).
550 000
520 000
488 000
Number of new CRC
cases diagnosed per
year
Global CRC Market
• Volume ~ $7 bln in 2011;
• Forecast ~ $11.5 bln in 2017 ;
• Drivers: population growth, increase in life expectancy, cancerogenic diet.
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6. Global CRC Market Structure
Global market structure in monetary terms
Monoclonal antibodies Pt based agents Topoisomerase inhibitors
Antimetabolite compounds
9%
Bevacizumab
13%
31%
47% Panitumumab
13% Cetuximab
31%
3%
“Gold standard” for current treatment metastatic colorectal cancer treatment- FOLFOX scheme:
5-fluorouracil/ Leucovorin/ Oxaliplatin
Current colorectal cancer therapies remain very toxic and do not improve quality of life for patients
with metastatic cancer.
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7. Russian Market (CRC)
Colorectal cancer is taking third place by prevalence in the structure of all cancers (Russian
Oncology Center);
Incidence
• 50,000 people new cases diagnosed with CRC;
• Incidence increasing over the last 10 years for over 14%;
• Almost 60% of the disease is diagnosed in stage III - IV, when the treatment is difficult and
not effective;
Treatment
• 240,000 patients in needed of treatment of
colorectal cancer and colon;
• The provision of necessary medicines - 5%;
• Market volume - $60M
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8. MM-D37K is a “chimeric” peptide:
1) Transport sequence
MM-D37K
p16
Cell
cycle
2) Cytotoxic sequence
cyclin D
cancer cells
p16
cyclin-dependent Apoptosis activation
kinase
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9. MM-D37K (in vitro)
• Fast speed of penetration into cells;
• The dynamics of accumulation in normal and tumor
cells do not differ on the nature and rate of
accumulation;
• The peptide is able to cross the membrane in both
directions;
• It is shown that the greatest activity is typical for
the p16-Antp vector (MM-D37K);
• High efficacy against wide spectrum of cancer types;
• Additive effect with etoposide, synergistic
effect with taxol.
Short-term human tumors:
• The most sensitive lines — colorectal cancer, pancreatic cancer, kidney cancer, breast cancer, gastric
cancer;
• Increased level of induced apoptosis in lymphocytes of patients (chronic lymphocytic leukemia)
compared with healthy lymphocytes.
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10. MM-D37K (in vivo)
Efficacy studies:
• Activity against gastrointestinal cancers;
• Additive effect with 5-fluorouracil
• Route of administration — intravenous
Pharmacokinetic studies:
HCT116, HCT116,
• Accumulation in vascularised organs – control 11,5x13,5 mm MM-D37K 4,5x4,5 mm
liver, spleen, lung and kidney;
• Fast blood clearance: Typical MS spectra
- Route of administration — intravenous
- Method of detection- LC-MS (ESI-TOF)
• Toxicity/safety studies:
Up to 100 mg/kg – mice, rats and rabbits (both sexes)
MM-D37K administration does not cause pathological changes in the brain, internal and
endocrine organs, does not affect water and food consumption.
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11. Pipeline Development
1) Expansion of MM-D37K indications
Pancreatic cancer Stomach cancer Bladder cancer Liver cancer Glioblastoma
2) R&D activities:
a) New cell-penetrating sequences searching (in silico)
Partner: Moscow State University - Mechanics and Mathematics Faculty
b) New cytotoxic sequences searching (in silico)
Partners:
- Moscow State University – Biological Faculty (department of biophysics)
- Moscow Institute of Physics and Technology
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12. R&D Activities
Peptide screening based on:
• Best energy binding with target protein CDK4(6) –
Vina and Umbrella sampling methods;
• Conformation changes in target protein CDK4(6).
Black — in vitro results of different p16 sequences
(Fåhraeus R et al “Characterization of the cyclin-
dependent kinase inhibitory domain of the INK4 family
as a model for a synthetic tumour suppressor molecule”
Oncogene. 1998 Feb 5;16(5):587-96.)
Red — computer modeling results
Possible commercialization results:
• pipeline development — p16 protein sequence optimization;
• pipeline/collaboration development — new sequences that inhibit “hot” targets;
• custom services — new sequences that inhibit “hot” targets for biotech companies and big pharma.
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13. Publications
• “Effect of metabolizable peptide p16INK4a on short-lived human tumor cultures”.
Bozhenko VK, Kulinich TM, Ivanov AV, Kudinova EA, Shishkin AM, Kharchenko VP.
Vop. Onkol. 2009;55(4):451-4;
• “Cytostatic and cytotoxic properties of chimeric peptides containing cyclin-inhibiting fragments”.
Kulinich TM, Kharchenko VP, Filyasova EI, Shishkin AM, Bozhenko VK.
Bull Exp Biol Med. 2008 Jan;145(1):37-40.;
• “Cytotoxicity of chimera peptides incorporating sequences of cyclin kinases inhibitors”.
Kharchenko VP, Kulinich VG, Lunin VG, Filiasova EI, Shishkin AM, Sergeenko OV, Riazanova
EM, Voronina OL, Bozhenko VK.
Vopr Onkol. 2007;53(4):448-52;
• 2 additional publications are coming soon:
- Preclinical summary of MM-D37K;
- Novel methods of molecular dynamics screening.
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14. Intellectual property
№ RU2435787* (issued) EA201100464 PCT/EA 2011/000343
Priority date 29.09.2010 06.04.2011 06.04.2011
«Chimeric peptide and it’s «Pharmaceutical
«Pharmaceutical composition
pharmaceutical composition composition for
Title for hyperproliferative disease
for cancer disease hyperproliferative disease
treatment»
treatment» treatment»
Inventor Bozhenko V.K. Bozhenko V.K. Bozhenko V.K.
Applicant MetaMax, Ltd. MetaMax, Ltd. MetaMax, Ltd.
* «Top-100 inventions in Russia» in 2011 year (Federal Institute of Industrial Property)
Aggressive patent strategy based on R&D activities
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15. Team
Chief Executive Officer
Andrey Boldyrev,
- project management experience within Russian National Union of
Business Angels;
- experience as an expert on intellectual property in the area of ​"biotechnology" in
the FGU FIPS (Federal service for intellectual property, patent and trademark);
- academic background with honors in biochemistry and professional
experience in bioorganic chemistry in Institute of Bioorganic Chemistry (Russian
Academy of Science)
Chief Scientific Adviser
Vladimir Bozhenko,
- Professor, PhD, MD, Honored Medical Doctor of the Russian Federation;
- Head of Department of Pathology and Laboratory Diagnostics at the Russian
Scientific Center of Radiology;
- Member of Dissertation Council at the Russian Federal Research
Center of Radiology (Rosmedtechnology);
- author of more than 160 publications and 7 patents.
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16. Advisers
Igor Rodionov - Ph.D. in Bioorganic chemistry;
- Deputy Head of the Laboratory of Peptide Chemistry- Branch of Shemyakin and Ovchinnikov Institute of
Bioorganic Chemistry (Russian Academy of Science);
- Senior Lecturer, Associate Professor of Pushchino State University;
- Research interests: peptide synthesis, optimization study of adverse reactions, development of new
methods for monitoring). Fine custom chemical synthesis of cyclic peptides, lipopeptides.
Yaroslav Kholodov - Ph.D. in Physics and Mathematical Sciences;
- Research Officer, Department of computational mathematics at the
Moscow Institute of Physics and Technology;
- Research interests: computer studies and modeling of high-
performance computing systems for computer simulation of
physical, chemical and biological processes.
Company is actively uses Maxwell Biotech competencies including scientific, clinical and development
assistance.
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17. Thank you for your attention
For more information, please contact:
Andrey Boldyrev, CEO
MetaMax, Ltd.
tel: +7 (495) 411-6992
office 3.29, Alexander House,
1 Bolshaya Yakimanka str.
Moscow, 119180, Russia
boldyrev@metamax.biz