Post on 06-May-2015
Company Overview
Presentation is prepared for Skolkovo Foundation
2012
Key Facts
• Company status
• Founded
• Our mission
• Main focus
• Technology platform
• Investors
• Partners
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Private Russian biotech company
2010
Developing and marketing innovative biopharmaceutical drugs targeting the most prevalent and dangerous systemic diseases
Oncology
Cell-penetrating peptides (CPP)
Maxwell Biotech Venture Fund
Maxwell Biotech Group
RVC
Skolkovo
StageProduct Screening Lead
optimization Preclinical Phase 1 Phase 2a
MM-D37K
MM-D37K
Novel peptides
Colorectal cancer
Other indications
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
Pipeline
Colorectal cancer
Other indications
Furtherdevelopment
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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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Global CRC Market
• Volume ~ $7 bln in 2011;
• Forecast ~ $11.5 bln in 2017 ;
• Drivers: population growth, increase in life expectancy, cancerogenic diet.
Colorectal cancer is a type of cancer characterized by neoplasia in the colon, rectum, or vermiform appendix
Number of new CRC cases diagnosed per
year
CRC is one of the leading causes of all cancer deaths worldwide and accounts for more than 600 000 deaths every year (WHO, 2011).
Market Overview (CRC)
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488 000520 000
550 000
31%
13%
9%
31%
13% 3%
Current colorectal cancer therapies remain very toxic and do not improve quality of life for patients with metastatic cancer.
Monoclonal antibodies Pt based agents Topoisomerase inhibitors
Antimetabolite compounds
“Gold standard” for current treatment metastatic colorectal cancer treatment- FOLFOX scheme:5-fluorouracil/ Leucovorin/ Oxaliplatin
Global market structure in monetary terms
Bevacizumab
Cetuximab
Panitumumab
Global CRC Market Structure
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Colorectal cancer is taking third place by prevalence in the structure of all cancers (Russian Oncology Center);
Russian Market (CRC)
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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
p16cyclin-dependent
kinase
p16
MM-D37K
cancer cells
Cell cycle
Apoptosis activation
MM-D37K is a “chimeric” peptide:
1) Transport sequence
2) Cytotoxic sequence
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cyclin D
• 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.
MM-D37K (in vitro)
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MM-D37K (in vivo)
HCT116, control 11,5x13,5 mm
HCT116, MM-D37K 4,5x4,5 mm
• 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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Pharmacokinetic studies:
• Accumulation in vascularised organs – liver, spleen, lung and kidney;
• Fast blood clearance:
- Route of administration — intravenous
- Method of detection- LC-MS (ESI-TOF)
Efficacy studies:
• Activity against gastrointestinal cancers;
• Additive effect with 5-fluorouracil
• Route of administration — intravenous
Typical MS spectra
1) Expansion of MM-D37K indications
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
Bladder cancer Liver cancerStomach cancer GlioblastomaPancreatic cancer
Pipeline Development
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R&D Activities
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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.
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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№ RU2435787* (issued) EA201100464 PCT/EA 2011/000343
Priority date 29.09.2010 06.04.2011 06.04.2011
Title
«Chimeric peptide and it’s pharmaceutical composition
for cancer disease treatment»
«Pharmaceutical composition for hyperproliferative disease
treatment»
«Pharmaceutical composition for
hyperproliferative disease 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)
Intellectual property
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Aggressive patent strategy based on R&D activities
Chief Scientific AdviserVladimir 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.
Chief Executive OfficerAndrey 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)
Team
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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.
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.
Advisers
Company is actively uses Maxwell Biotech competencies including scientific, clinical and development assistance.
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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
Thank you for your attention