Development of Drugs to Slow  the Aging Process and Treat        Age-Related Diseases                   Tartis-Aging, LLC
Brief Description of Innovation ProjectGeneral Description  Aging is major factor for incidence of a broad number of dise...
History of the Project and Current Stage History of the Project                            Current Stage The basis of the...
Outlooks for Future Development The product under development have to fulfill following requirements:  1) selectively kil...
Development planIn spite of the conceptual possibility of eliminating of SC has already been shown by the Project team, th...
Target Market and Competitors                                                                            Development of si...
Target Market and Competitors Market segments related to the product:                      Potential customers of the prod...
Team and Co-investor Short description of the members of Project teamProject leader:                                     M...
Roadmap and Financial Plan                 Commercialization Plan                                     R&D Plan            ...
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  1. 1. Development of Drugs to Slow the Aging Process and Treat Age-Related Diseases Tartis-Aging, LLC
  2. 2. Brief Description of Innovation ProjectGeneral Description  Aging is major factor for incidence of a broad number of diseases such as cardiovascular conditions and stroke, atherosclerosis and hypertension, osteoporosis, prostate enlargement and prostate cancer, seborrheic keratosis and skin cancer, type 2 diabetes and diabetic retinopathy, macular degeneration, Alzheimers disease, and Parkinsons disease.  Broad experimental data confirm that the origin of aging and associated age-related diseases is the accumulation of senescent cells (SC) in body tissues  The Project is dedicated to development of first-in-class drugs that selectively destroy SC, which are aimed to prevent and treat age-related pathologies.  The Project includes screening of chemical libraries, characterization and optimization of hits, preclinical and clinical development of drug-candidatesStage of the Project for which the application submitted Early stage (Stage 2): Completion of R&D, preclinical investigation, early phases of clinical trials 2
  3. 3. History of the Project and Current Stage History of the Project Current Stage The basis of the Project is intellectual  An original technological platform has been developed property (know-how) developed in one of the enabling the fast high throughput screening (HTS) of leading institution in the US Roswell Park chemical libraries Cancer Institute (RPCI), and licensed to  A number of active compounds – ‘hits’ was identified Tartis-Aging with selective toxicity to SC (proof-of-concept) In April 2011 the Project received the  Furthermore, the hits were characterized, validated; investments from Bioprocess Capital H2L optimization for most potent active compounds Ventures Fund was initiated As the result of research conducted during  A number of molecular targets of SC have been first year of R&D activities a patent identified, which enables target-based screening of application was submitted to US patent office chemical libraries in drug discovery 3
  4. 4. Outlooks for Future Development The product under development have to fulfill following requirements: 1) selectively kill at least one type of SC, 2) show the activity in submicromolar concentrations, 3) possess favorable pharmacological profile (microsomal stability, solubility, absorption/excretion kinetics), 4) have at least 10-fold therapeutic window It is planned to start phase I clinical trials for the first indication, which will be selected as a result of R&D activities in a framework of Project implementation Currently a number active hits have been identified with selective toxicity to SC in submicromolar concentrations. For most potent compounds it is planned to investigate in depth the parameters of selectivity on extended panel of cell cultures, perform H2L optimization in order to improve activity, selectivity and pharmacological properties. First data about the mechanism of selective elimination of SC were obtained enabling the target-based drug discovery and increasing the chance of success Project implementation was initiated in March 2011 (investments from BCV Fund). The exit is planned to the end of 2017. To this moment the Project have to reach phase III clinical trials for the first selected indication. The marketing of the first product is assumed to begin in – 2018-2020 4
  5. 5. Development planIn spite of the conceptual possibility of eliminating of SC has already been shown by the Project team, theProject possess significant risks of not-finding the active compounds with appropriate therapeutic andpharmacological profile. R&D plan is primarily dedicated to de-risking activities.R&D plan includes: Completion of screening and characterization of hits (at this stage HTS will be performed and several potent compounds will be selected for further development, physico-chemical and pharmacological properties will be investigated) H2L optimization (at this stage the target libraries will be created around the potent hits in order to find an optimal balance between activity, selectivity and pharmacological properties) Selection of drug-candidate for preclinical and clinical development Development of diagnostic tool for detection of SC in vivo (this stage is essential for demonstration of correlation between deletion of SC and its effect on the diseases in a course of preclinical and clinical development) Preclinical development, submission of IND file (besides the preclinical investigations, GMP production of drug form will be developed) Start of phase I clinical trials (granting the approval from the Ministry of Health, selection of clinical base, selection of CRO) 5
  6. 6. Target Market and Competitors Development of similar productsConsumer needs Currently, Systemic Aging Syndrome (SAS), which is characterized by a decline in theThe main advantage of the company’s approach is the functional efficiency and regenerative potentials of a variety of tissues, as well as by chronicpharmacological treatment of the cause of age-related systemic inflammation, has not been regarded as a disease requiring treatment. As apathologies, namely, the accumulation of senescent cells. consequence, it has not been covered by medical insurance. This situation is attributable toCurrently the standards of care for treatment of age-related the fact that aging is viewed as a "law of nature" whose exact mechanism is still not fullydiseases utilize the symptomatic approach: the treatment is understood and, for this reason, it is thought that a pharmacological intervention aimed atfocused on the disappearance of certain symptoms. preventing or treating SAS is unnecessary. On the other hand, age-related disorders areMoreover, most drugs have a rather narrow spectrum of regarded as diseases. An understanding of the specific mechanisms behind thetreatment application for strictly defined pathologies. pharmacological treatment of SAS, along with the development of drug products for SAS,Therefore, the emergence of a drug on the market, a drug that demonstrating the efficacy of preventing age-related disorders, should lead to theacts on the cause of disease and shows efficacy against acknowledgement of SAS as a disease. Nevertheless, until such time as SAS is deemed toseveral pathologies, is demanded on the market and will get a be a disease, medicinal agents against SAS can be regarded only as drugs for age-relatedsignificant competitive advantage over the existing analogs on disorders, which as a group occupy a major share of the drug market in developed nations.the market. At first, therefore, the company plans to develop drugs against senescent cells as an adjuvant therapy in cancer treatment and as a dermatological remedy for skin rejuvenation. In parallel, the research track aimed at preventing and treating age related diseases will be elaborated. Direction Existing competitors Business model Disadvantages Sales - No proof of pharmacological efficacy 60M USD (Russia, 2011) Aging BAS (Antioxidants) Retail sales market - Are not permitted to be sold as drugs 2.4B USD (USA, 2011) No direct competitors - During radiation therapy and chemotherapy, a The drugs will be applied in Governmental purchases (Russia) substantial portion of tumor cells become senescent 22.5B Rub (Russia, 2009) Oncology combination with current standards of Medical Insurance (USA) - Risks of relapse and formation of secondary tumors 23.2B USD (USA, 2011) care, partially occupying their market - Conservation of tumor bulk → mechanical problems Restricted indications (acne, photoaging) Tretinoin Pharmacy sales Adverse effects – thinning of skin, increased risk of 100M USD (USA) Dermatology sun burns Adverse effects (edema, decrease of sensitivity of Botulinum toxin А Purchases by cosmetic clinics 1B USD (world) mimic muscles, mask-like face) 6
  7. 7. Target Market and Competitors Market segments related to the product: Potential customers of the product:  Age-related diseases  Newly diagnosed breast cancer: 53 000 – in Russia, 190 000 – in US  Adjuvant therapy for cancer treatment  Newly diagnosed breast cancer: 23 000 – in Russia, 200 000 – in US  Dermatological drugs for skin rejuvenation  Number of elderly (65+) in the world 650 000 000  Alzheimer disease in certain form is diagnosed in 10% of elderly (65+) Target geographical markets :  Atherosclerosis prevalence– 1.7% of population  Russia  USMarket appraisal, mln USD 2012 2017 2020 Antioxidants (analog for anti-aging drugs) 2 500 3 100 3 400USA Cosmeceuticals (dermatological drugs) 7 300 9 000 9 850 Antioxidants (analog for anti-aging drugs) 70 100 120Russia Drugs for cancer treatment 1 100 2 270 2 720 Cosmeceuticals (dermatological drugs) 540 800 970 7
  8. 8. Team and Co-investor Short description of the members of Project teamProject leader: Manager Investment planLeonov А.А.  2006 – current Bioprocess Group, Manager for Development Fund raising for the current stage General manager general management, interaction with  2003-2005 – Clinical research  Bioprocess Capital Ventures closed-end venture investment shareholders, BoD assistant, Novartis fund part-time employment  1996-2003 – Scientist in Lomonosov MSU, Max-Plank-institute (Germany)  Method of providing funding: Investment into share capital Scope of activity: biotechnology, pharmaceutics, venture  Education: Department Chemistry, Lomonosov  To date, in addition to Tartis-Aging, the portfolio of the Fund investment Moscow State University, PhD includes several innovative pharmaceutical and 2010 – current Incuron LLC General Manager biotechnological companies: TheraMAB, Incuron, OncoTartis and Promogen-MAT. 2011 – current OncoTartis LLC General Total investments in biotechnology projects amounted in roughly $45 million. TheraMAB, Incuron and OncoTartisZinchenko А.V. (Netherlands) became residents of Skolkovo and received funding from the Project Manager  2005-2009 – Group leader at Department Skolkovo Fund. coordinates the activities with American site Pharmacy, Ludwig-Maximilian-University of  The net assets value – 3.5B rubles and interact with Russian contract research Munich organizations  Education: Department Chemistry, Lomonosov  Due to the end of operation of the Fund at the end of part-time employment Moscow State University, PhD – Potsdam 2017, the exit of the Fund is planned before Scope of activity: University commercialization of Company’s products will start biotechnology, pharmaceutics, nanomedicine 2009-2011 – Scientist at University of Twente Fund raising for further stages of the ProjectDorozhko О.V.  2006-2010 – Manager Business Development,  Fund does not exclude the possibility of attraction of Senior Specialist for Preclinical and clinical AVVA Pharmaceuticals AG additional funding for development of the project to a more development  2002-2004 –Head Product Development, advanced stage. The sources of funding could be either planning and control on conduction of «Intercare» investments of the strategic partner or grants preclinical studies, making up the IND file  Education: Saratov State Medical Institute, MD,  Necessary investments for completion of clinical trials in Full-time employment PhD, DSc Russia and the US on selected nosologies are estimated in Scope of activity: pharmacology/biotechnology.  70+ publications and patents amount of 1-2B rubles Development and production of novel original drugs, modified generics and biosimilars. Patenting of original inventions, including foreign patent agencies 8
  9. 9. Roadmap and Financial Plan Commercialization Plan R&D Plan In the second round of funding, it is planned to complete the screening of chemical libraries and proceed to chemical optimization Project RF US of promising active molecules, to choose a drug candidate and Market Market initiate the preclinical development program. Based on the results of Senescent Cells Suppressor (first the preclinical studies it is planned to submit an IND file in Russia Q38 Q44 indication) and to obtain approval to conduct clinical trials of a single drug Senescent Cells Suppressor (alternative candidate for use in oncology or for use as a dermatological agent Q44 Q52 indication) for skin rejuvenation. The first indication for clinical trials will be selected based on the results of preclinical studies (efficiency and toxicity profiles of different drug forms). To finance the second stage of the project, it is planned to attract an additional funding from Bioprocess Capital Ventures and the Skolkovo Fund. Investment Plan Round 2 Round 3 Round 1 (finished) Quarter 7 – Quarter 16 Quarter 17 – and BeyondRound Quarter 1 – Quarter 6 Elaboration of Drug Candidates and Performance of Clinical Trials and Project Feasibility Demonstration Preclinical Research CommercializationAmount of Financing 87,895,000 300,000,000 1,000,000 – 2,000,000,000  Completion of screening and hit optimization, selection of  Screening of chemical libraries, leads and testing of their attributes in vivo  Performance of clinical trials in search for small molecules selectively  H2L optimization and selection of a candidate for Russia and the US, and registration killing SCProject Performance preclinical trials. of the drug product.  Physicochemical description andBenchmarks  Design of a diagnostic test for measuring SC in vivo  Clinical trials on alternative optimization of prospective hits;  Preclinical Trials indications  Search for molecular targets for  Preparation and submission of IND file selective destruction of SC  Begin of Phase I clinical Trials in Russia 9