MetaMax presentation for Skolkovo

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  • 1.Company OverviewPresentation is prepared for Skolkovo Foundation2012

2. Key Facts Company statusPrivate Russian biotech company Founded 2010 Our mission Developing and marketing innovative biopharmaceutical drugstargeting the most prevalent and dangerous systemic diseases Main focusOncology Technology platform Cell-penetrating peptides (CPP) Investors Maxwell Biotech Venture Fund Partners Maxwell Biotech Group RVC Skolkovo2 3. PipelineFurtherdevelopment Stage LeadScreening Preclinical Phase 1 Phase 2aProductoptimization MM-D37K Colorectal cancer Colorectal cancer MM-D37KOther indications Other indicationsNovel peptides2012 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 optimization3 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 kinaseinhibition mechanism; Market potential: Global CRC market ~ $7 billion with unmet clinical need to decrease toxicity of currentchemotherapy 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/synergi effect withtraditional chemotherapeutic agents; In vitro and in vivo activity demonstrated in different tumor types; Development status: preparing regulatory registration package to initiate clinical trials onpatients with gastric cancers.4 5. Market Overview (CRC)Colorectal cancer is a type of cancer characterized by neoplasia in the colon, rectum, or vermiform appendixCRC is one of the leading causes of all cancer deaths worldwide and accounts for more than 600 000 deathsevery year (WHO, 2011). 550 000520 000 488 000Number of new CRCcases diagnosed peryearGlobal CRC Market Volume ~ $7 bln in 2011; Forecast ~ $11.5 bln in 2017 ; Drivers: population growth, increase in life expectancy, cancerogenic diet.5 6. Global CRC Market StructureGlobal market structure in monetary terms Monoclonal antibodiesPt based agents Topoisomerase inhibitorsAntimetabolite compounds 9% Bevacizumab 13%31% 47% Panitumumab13%Cetuximab 31%3%Gold standard for current treatment metastatic colorectal cancer treatment- FOLFOX scheme:5-fluorouracil/ Leucovorin/ OxaliplatinCurrent colorectal cancer therapies remain very toxic and do not improve quality of life for patientswith metastatic cancer.6 7. Russian Market (CRC)Colorectal cancer is taking third place by prevalence in the structure of all cancers (RussianOncology 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 andnot effective;Treatment 240,000 patients in needed of treatment ofcolorectal cancer and colon; The provision of necessary medicines - 5%; Market volume - $60M7 8. MM-D37K is a chimeric peptide:1) Transport sequence MM-D37K p16 Cell cycle2) Cytotoxic sequence cyclin D cancer cells p16cyclin-dependent Apoptosis activationkinase 8 9. MM-D37K (in vitro) Fast speed of penetration into cells; The dynamics of accumulation in normal and tumorcells do not differ on the nature and rate ofaccumulation; The peptide is able to cross the membrane in bothdirections; It is shown that the greatest activity is typical forthe p16-Antp vector (MM-D37K); High efficacy against wide spectrum of cancer types; Additive effect withetoposide, synergisticeffect with taxol.Short-term human tumors: The most sensitive lines colorectal cancer, pancreatic cancer, kidney cancer, breast cancer, gastriccancer; Increased level of induced apoptosis in lymphocytes of patients (chronic lymphocytic leukemia)compared with healthy lymphocytes.9 10. MM-D37K (in vivo)Efficacy studies: Activity against gastrointestinal cancers; Additive effect with 5-fluorouracil Route of administration intravenousPharmacokinetic studies:HCT116, HCT116, Accumulation in vascularised organs control 11,5x13,5 mm MM-D37K 4,5x4,5 mmliver, 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 andendocrine organs, does not affect water and food consumption. 10 11. Pipeline Development 1) Expansion of MM-D37K indicationsPancreatic cancer Stomach cancerBladder cancer Liver cancerGlioblastoma 2) R&D activities:a) New cell-penetrating sequences searching (in silico)Partner: Moscow State University - Mechanics and Mathematics Facultyb) New cytotoxic sequences searching (in silico)Partners:- Moscow State University Biological Faculty (department of biophysics)- Moscow Institute of Physics and Technology 11 12. R&D ActivitiesPeptide 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(Fhraeus R et al Characterization of the cyclin-dependent kinase inhibitory domain of the INK4 familyas a model for a synthetic tumour suppressor molecule Oncogene. 1998 Feb 5;16(5):587-96.)Red computer modeling resultsPossible 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. 12 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, RiazanovaEM, 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. 13 14. Intellectual property RU2435787* (issued)EA201100464 PCT/EA 2011/000343 Priority date 29.09.201006.04.2011 06.04.2011Chimeric peptide and its Pharmaceutical Pharmaceutical composition pharmaceutical compositioncomposition for Title for hyperproliferative disease for cancer diseasehyperproliferative diseasetreatment treatmenttreatment InventorBozhenko V.K.Bozhenko V.K.Bozhenko V.K.ApplicantMetaMax, 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 activities14 15. TeamChief Executive OfficerAndrey Boldyrev,- project managementexperiencewithin RussianNational UnionofBusiness Angels;- experience as an expert on intellectual property in the area of "biotechnology" inthe FGU FIPS (Federal service for intellectual property, patent and trademark);- academic background with honors in biochemistry and professionalexperience in bioorganic chemistry in Institute of Bioorganic Chemistry (RussianAcademy of Science)Chief Scientific AdviserVladimir Bozhenko,- Professor, PhD, MD, Honored Medical Doctor of the Russian Federation;- Head of Department of Pathology and Laboratory Diagnostics at the RussianScientific Center of Radiology;- Member of Dissertation Council atthe Russian Federal ResearchCenter of Radiology (Rosmedtechnology);- author of more than 160 publications and 7 patents. 15 16. AdvisersIgor Rodionov - Ph.D. in Bioorganic chemistry;- Deputy Head of the Laboratory of Peptide Chemistry- Branch of Shemyakin and Ovchinnikov Institute ofBioorganic Chemistry (Russian Academy of Science);- Senior Lecturer, Associate Professor of Pushchino State University;- Research interests: peptide synthesis, optimization study of adverse reactions, development of newmethods 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 theMoscow Institute of Physics and Technology;- Research interests: computer studies and modeling of high-performance computing systems for computer simulation ofphysical, chemical and biological processes.Company is actively uses Maxwell Biotech competencies including scientific, clinical and developmentassistance. 16 17. Thank you for your attention For more information, please contact:Andrey Boldyrev, CEOMetaMax, Ltd.tel: +7 (495) 411-6992 office 3.29, Alexander House, 1 Bolshaya Yakimanka str. Moscow, 119180, Russia boldyrev@metamax.biz