Slide 1: Investor update: RSV older adults and maternal vaccine candidates
Investor update: RSV older adults and maternal vaccine candidates Data presented at ID Week 2020 22 October 2020 1
Slide 2: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 3: Agenda
Agenda R&D approach and RSV burden of disease Dr Hal Barron Chief Scientific Officer and President R&D Vaccines R&D and RSV vaccines data Dr. Emmanuel Hanon Senior Vice President, Vaccines R&D Presentation Q&A RSV opportunity 25 mins 25 mins Roger Connor President, Global Vaccines Q&A 3 RSV, respira
Slide 4: Strengthening our R&D pipeline through focus on immune system science
Strengthening our R&D pipeline through a focus on science related to the immune system, the use of human genetics, and advanced technologies 4
Slide 5: Our focus on immunology is resulting in a world class Infectious Diseases portfolio
Our focus on immunology is resulting in a world class Infectious Diseases portfolio First time in human (Phase 1) Proof of concept (Phase 1b/2) Pivotal (Phase 2/3) Marketed 3858279* (CCL17 inhibitor) OA pain 3640254 (maturation inhibitor) HIV Benlysta3 + Rituxan SLE** Shingrix 3745417 (STING agonist
Slide 6: RSV vaccine opportunity: high unmet need
Innovation RSV vaccine opportunity: high unmet need Burden most significant in infants and older adults • Common respiratory virus that can be serious, especially for infants and older adults • Most common cause of bronchiolitis and pneumonia in RSV-associated hospitalisation burden in the USA5 Abou
Slide 7: Vaccines R&D approach
Vaccines R&D approach Dr. Emmanuel Hanon Senior Vice President and Head of R&D, GSK Vaccines 7
Slide 8: Our R&D approach for vaccines
Innovation Our R&D approach for vaccines Design and deliver ground-breaking vaccines • Shingrix and MenABCWY (lifecycle management) • Key priority assets: RSV older adults, maternal, paediatric • Therapeutic (Chronic HepB) • Antimicrobial resistance (C. Difficile, S. Aureus) Leverage disruptive tech
Slide 9: Vaccines innovation approach built on platform technologies
Innovation Vaccines innovation approach built on platform technologies Adjuvant systems Bioconjugation Improve efficacy Faster, simpler and more efficient development & manufacturing Adenoviral mRNA vectors 9
Slide 10: GSK Vaccines Pipeline
Innovation GSK Vaccines Pipeline Phase 1 / 2 Phase 2 Phase 3 Clostridium difficile AS01 RSV paediatric Shingrix immuno-compromised1 AS01 Approved in EU, filed in US Recent AS01 start Staphylococcus aureus Therapeutic chronic hepatitis B AS01 Bexsero paediatric (US) SAM (rabies model) Menveo liquid2
Slide 11: GSK approach to RSV vaccines
GSK approach to RSV vaccines 11
Slide 12: Pre F protein structure gives greater chance of success
Pre F protein structure gives greater chance of success Previous approach GSK Approach Limited success with post fusion RSV F New generation pre fusion RSV F protein protein which hides critical neutralising sites exposes multiple essential neutralising sites Image of F protein reprinted from Curr O
Slide 13: RSV vaccine candidates
Innovation RSV vaccine candidates Target protection against RSV across 3 key target populations 3 RSV vaccine candidates - All with FDA fast track designation maternal paediatric + older adults passive immunisation active immunisation AS01 active immunisation Features pre-fusion antigen Immunologica
Slide 14: Key data on immunogenicity and tolerability for Maternal Vaccine Candidate
Maternal Key data on immunogenicity and tolerability for Maternal Vaccine Candidate (RSVPreF3) Administered to Non-pregnant Women Data first presented at ID Week 2020 21 October 2020 14
Slide 15: Study designed to evaluate multiple doses in non-pregnant women
Maternal Study designed to evaluate multiple doses in non-pregnant women Study summary Healthy non-pregnant women • Phase I/II, randomised, observer-blind, placebo controlled, Ages 18-45 years randomized to 4 multicentre study to evaluate the safety, reactogenicity and groups (N = 500) immunogenicit
Slide 16: One dose is highly immunogenic and persistent at all dose levels
Maternal One dose is highly immunogenic and persistent at all dose levels 8-14 fold increase in RSV- A and RSV-B neutralising antibodies titers at Day 8. Persistent immune response of 5-6 fold antibodies increase was maintained at day 91. Geometric mean of foldGeometric increase mean of fold increas
Slide 17: All doses well tolerated
Maternal All doses well tolerated Safety summary • One dose administered all dose levels was well-tolerated • The most frequently reported solicited adverse events were pain at injection site and headache • Low reporting of Grade 3 solicited and unsolicited AEs • No clinically significant changes in
Slide 18: Key data on immunogenicity and tolerability for Older Adults Vaccine Candidate
Older Adults Key data on immunogenicity and tolerability for Older Adults Vaccine Candidate Data first presented at ID Week 2020 21 October 2020 18
Slide 19: Study designed to evaluate antigen and adjuvant vaccine doses in target population
Older Adults Study designed to evaluate antigen and adjuvant vaccine doses in target population Study summary Part A – Young Part B – Older Adults • Phase 1 / 2, placebo-controlled, multi- Adults Ages 60-80 years randomized to 10 groups (N= 1000) country trial Ages 18-40 years randomized to 4 groups
Slide 20: Results in older adults showed strong induction of antibody and T-cell response
Older Adults Results in older adults showed strong induction of antibody and T-cell response Antibody Response T-cell Response Pre-specified phase 1 / 2 success criteria: at least 6-fold increase in Pre-specified phase 1 / 2 success criteria: statistically demonstrated RSV-A neutralising antibodies
Slide 21: Compelling neutralising antibody response and T-cell restoration
Older Adults Compelling neutralising antibody response and T-cell restoration Antibody Response T-Cell Response Young Adults Older Adults Young Adults Older Adults 1 month post vaccination: Restored RSVPreF3 CD4+ T- cell frequencies in older adults close to young adult level GMTs and 95% CIs for RSV
Slide 22: Well tolerated in older adults
Older Adults Well tolerated in older adults Safety summary • First dose was well tolerated • Most frequently reported AEs were pain at injection site, fatigue and headache. • AE rates tended to be higher after AS01B-adjuvanted formulations compared to other vaccine formulations in OA; grade 3 AE rat
Slide 23: RSV opportunity
RSV opportunity Roger Connor President, GSK Vaccines 23
Slide 24: RSV older adults represents major opportunity
RSV older adults represents major opportunity Significant, widespread Vaccination offers likely First-in-class potential health burden best solution • ~70m1 age 60+ (target US • Older adults are at greater risk than • Data supports adjuvanted approach population) young adults for serious for boostin
Slide 25: Maternal vaccination offers potential for broad protection from birth to 6 months
Maternal vaccination offers potential for broad protection from birth to 6 months Burden most significant in young infants Integrated maternal and paediatric programmes target protection where burden most significant • ~4m annual birth cohort in the US1 1-dose 2-dose • Leading cause of hospitalisati
Slide 26: Our RSV assets offer a compelling opportunity for GSK
Our RSV assets offer a compelling opportunity for GSK Opportunity is significant Data support move to pivotal studies • Potential first-in-class with differentiated adjuvant • Compelling neutralising antibodies response and T-cell restoration in older adults; well tolerated • 70m adults age 60+ in t
Slide 27: Q&A
do more feel better live longer Q&A