RUSSIAN DIRECT INVESTMENT FUND Sputnik V Key Facts The first - PowerPoint PPT Presentation

RUSSIAN DIRECT INVESTMENT FUND

Sputnik V Key Facts The first registered Over 44,000 people COVID-19 vaccine in Sputnik V clinical trials in the world worldwide Prime-boost vaccination Countries with over achieves recognized 50% of world population long lasting immune have expressed interest response in Sputnik V vaccination Safe and well-studied Over 1 bn people platform since 1953 and to be vaccinated used for the vaccination of by Sputnik V in 2020-2021 over 10 mln people 2

Collaboration Russian Direct The Gamaleya The Gamaleya Center Investment Fund (RDIF) Center On August 11, 2020, Sovereign Wealth Fund National Research Center in partnership with of Russia established in 2011 of Epidemiology and the Gamaleya Center Microbiology RDIF launched the first RDIF has played a key role n. a. N.F. Gamaleya is information website in fighting COVID-19 the world’s leading research in Russia. The Fund has on a Russian coronavirus institution founded in 1891 selected and funded the most vaccine coronavirus at The Center successfully promising testing system www.sputnikvaccine.com created the world’s first (COVID-19 SmartAmp), drug (Avifavir) and vaccine Ebola virus vaccine . A MERS This website has been (Sputnik V) for COVID-19 vaccine is currently created to provide in advanced stages of accurate and up-to- RDIF is supporting the clinical trials. Both vaccines date information about development of Russia’s are based on the human Sputnik V COVID-19 vaccine by the adenovirus vector platform Gamaleya Center used for Sputnik V The Center runs one of RDIF has the exclusive license the world’s only “virus for the sale and manufacture collections” and has its own of Sputnik V vaccine in vaccine production facility international markets 3

Key Development Milestones Russian Sputnik V is the world’s first Human Adenovirus Vector-based COVID-19 vaccine NOVEMBER 2020: Start of global vaccine supplies AUGUST 3 RD 2020: Completion of phase AUGUST 11 TH 2020: I-II of clinical trials Vaccine registration BY YEAR END 2021: in Russia Global supply of vaccine over 1 bn doses EARLY 2018: SEPTEMBER 2020: MERS (Middle East Respiratory Start of mass vaccine Syndrome)* candidate vaccine production in Russia developed by the Gamaleya Center END OF AUGUST 2020: FEBRUARY 2020: Launch of unprecedented Start of work on Sputnik V* post-registration multinational vaccine developed Phase III clinical trials EARLY 2014: by the Gamaleya Center on over 44,000 volunteers Ebola* vaccine developed by the Gamaleya Center * Vector platform based on human adenoviruses 4

International Sales Footprint Over 25 countries comprising over 50% of the world’s population have expressed interest in using Sputnik V for vaccinations, including in Latin America, India, UAE, Saudi Arabia, Indonesia, Philippines Russia Mexico Kuwait Kazakhstan Venezuela Turkey Brazil Serbia Uzbekistan Bosnia and Herzegovina Peru Palestine Argentina South Korea Nepal Vietnam Philippines UAE Indonesia Saudi Arabia Malaysia Israel Egypt Bangladesh Algeria India 5

Recognition from the Global Scientific Community ,, Polina Stepensky Selected Quotes Сhair of the Bone Marrow Transplantation and Cancer Immunotherapy Department at Hadassah hospital, Israel The first thing I should say to Russian scientists and Russian health professionals is ‘Bravo!’. This technology and scientific approach we perfectly understand and absolutely approve. You have achieved ,, Zhong Nanshan a real breakthrough in science and in medicine. We are really grateful that you have done a wonderful job Director of the Guangzhou Institute of Respiratory Diseases, China I am highly complimentary about the COVID-19 vaccine, developed by the Gamaleya Center. Let me congratulate your country on the completion of the state registration procedure. ,, Hildegund Ertl The Russian adenoviral vaccine is safe and should successfully complete its clinical trials Professor, Vaccine & Immunotherapy Center at the Wistar Institute in Philadelphia, USA ,, Ian Jones From what I’ve seen out there, they are probably the most promising platform Virology professor at Reading University, United Kingdom There is enough general background data on recombinant adenovirus-based vaccines to assume the vaccine itself will be safe at the usual doses 6

Vaccine Overview

Human Adenovirus Vector (Ad 5) and Vector (Ad 26) Platform Vaccine does not contain live human adenoviruses, but contains human adenovirus vectors that cannot multiply in the body and are completely safe The approach of the Gamaleya Center with the vaccine using the most prudent prime-boost (two doses) vaccination regimen with two vector serotypes: number 5 (Ad5) and number 26 (Ad26) has a clear advantage over the one-vector approach used by other pharmaceutical companies The vaccine induces strong response forming antigen-specific cells of both populations of T-lymphocytes: T-helper (CD4+) and T-killer (CD8+) It has elicited IgG response in 100% immunized participants in mean titers significantly higher than titers of COVID-19 convalescents 8

Two-Boost Vaccination with Different Vectors Second vaccination Vector creation First vaccination Another vaccination with A vector is a virus that lacks Vector (Ad 26) with Vector (Ad 5) takes place a gene responsible for a gene coding S-protein in 21 days reproduction and is used to of coronavirus gets into transport genetic material from cell The vaccine based on another virus that is being another adenovirus vaccinated against into cell As cell synthesizes vector unknown to the S-protein , the A gene coding S-protein of body boosts the immune development of SARS-COV-2 spikes is inserted response and provides immunity begins into each vector long-lasting immunity 9

Unique Combination of Different Vector Types to Form Long Lasting Immunity University of Oxford/ AstraZeneca A breakthrough idea of using Change from single- shot to double- two different types of adenovirus shot regimen with ChAdOx1 for both vectors prime and boost immunization Loss of boost The Gamaleya Center immunization efficacy due to anti-vector Ad26 for prime response immunization High efficacy of both prime and boost Ad5 for boost Johnson & Johnson immunization immunization Ad26 for both prime and boost immunization 10

Advantages of Two Different Vectors During Immunization First immunization Second immunization - boost 1 1 1 The same Ad vector 1 1 1 1 Homologous immunization 1 1 anti- vector 1 immunity Inefficacy of boost immunization 1 1 1 due to anti- vector immunity 1 1 anti- vector immunity blocks 1 vector penetration into cells 1 Inside 2 human Another Ad vector 5’ 3’ cell Heterologous immunization S protein 2 expression Efficient boosting 2 of anti- S protein immunity 2 2 2 2 2 2 anti- S protein 2 immunity 2 2 2 5’ 3’ 2 S protein expression 11

Clinical Trials

Pre-Clinical Study Study: Immunogenicity: mice Mus musculus, Balb/C hamsters (Mesocricetus auratus) Marmosets (Callithrix jacchus) Protects 100% Rhesus macaque (Macaca mulatta) of animals Results: Immediate Vaccine protects 100% immunosuppressed hamsters availability of (Mesocricetus auratus) from lethal infection with SARS- antibodies CoV-2 Vaccine elicited robust humoral and cellular immune response in non-human primates and allowed to protect them from SARS-CoV-2 infection No adverse drug event was observed in vaccinated and SARS-CoV-2 challenged animals 13

Phase I/II Study Design: Non-Randomised, Open Label, two-stage study in Parallel Assignment Number of subjects: 76 healthy volunteers of both sexes Age group: 18 to 60 inclusively No unforeseen Study duration: or unwanted side First participant screening: June 17 th 2020 effects… Completion of the 28 th day of observation: July 20 th 2020 Completion of the 42 th day of observation: August 3 rd 2020 …additionally supported by track Results: record of past The heterologous rAd26- and rAd5-vectored COVID-19 vaccine has a good safety profile, does not cause serious clinical studies adverse events and induces strong humoral and cellular immune response in 100 % of participants There is no scientific or clinical evidence of any side effects associated with the vaccine 14

Phase III Study Multicenter clinical trials Design: Randomized, double-blind, placebo controlled, multi-centre clinical trial in parallel assignment of the efficacy, immunogenicity and safety Studies on over Number of subjects: 44,000 participants, 44,000 people 3:1 vaccine to placebo worldwide under international Age group: 18 to 60+ standards and Current status: ongoing supervision Countries: Russia Saudi Arabia Egypt India UAE Philippines Brazil Others 15

Sputnik V - Recap