Valneva Se · EURONEXT:VLA
Valneva — ISV South Korea 2024
17 slides from Valneva's conference presentation, Oct 21, 2024
Slide 1: Two-Year Antibody Persistence and Safety of VLA1553 Chikungunya Vaccine
TWO-YEAR ANTIBODY PERSISTENCE AND SAFETY OF A SINGLE-DOSE LIVE- ATTENUATED CHIKUNGUNYA VIRUS VACCINE (VLA1553) IN ADULTS AGED 18 YEARS AND ABOVE 21-Oct-2024 Susanne Eder-Lingelbach VP Clinical Development
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an Certain information and statements included in this presentation are not historical offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any facts but are forward-looking sta
Slide 3: Valneva: A leading specialty vaccine company
Valneva A leading specialty vaccine company Focused on vaccines that make a difference Proven, Integrated Expertise: Three in-house vaccine approvals; three proprietary commercialized travel vaccines Focused R&D: Advancing first-, only- or best-in-class vaccine candidates; Experience across multiple
Slide 4: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-transmitted disease with potentially debilitating consequences Chikungunya virus (CHIKV) is transmitted by Aedes mosquitoes1 Acute chikungunya, seen in around 75% of those infected, typically presents with sudden onset of high fever and joint pa
Slide 5: Chikungunya: A Global Threat
Chikungunya: A Global Threat Chikungunya virus has been identified in >110 countries on all continents except Antarctica1 Countries reporting CHIKV cases during the last 5 years*3,4 Chikungunya virus (CHIKV) was first identified in Tanzania in 19521 Over the following ~50 years CHIKV was geograp
Slide 6: High Acute Morbidity: Can Lead to Chronic Incapacitation
High Acute Morbidity: Can Lead to Chronic Incapacitation Lasting months to years in a high proportion of patients Acute Phase Chronic Phase (~75% of cases)9 (~43% of cases)5 Symptoms typically begin 3-7 days after being bitten by an Long-term suffering differs per study:6-8 infected mosquito1 ›
Slide 7: Chronic Chikungunya Negatively Impacts Quality of Life
Chronic Chikungunya Negatively Impacts Quality of Life Persistent rheumatologic disease Post-CHIKV rheumatism Effect of arthritis/ Joints typically involved Impact on 2 forms polyarthritis by polyarthritis5 life activities1-4 Mechanical musculoskeletal Long-term joint pain1-3 Hands Standing up d
Slide 8: Licensure Pathway for Chikungunya Vaccines
Licensure Pathway for Chikungunya Vaccines Accelerated approval pathway agreed with regulators for chikungunya vaccines Classical efficacy studies for chikungunya vaccines are considered unfeasible in a pre-licensure setting1 • Unpredictable and short-lived outbreaks • Logistical boundaries • Accept
Slide 9: Evidence Supporting the Serological Endpoint
Evidence Supporting the Serological Endpoint After transfer of human post-vaccination sera, neutralizing antibodies conferred sterilizing immunity in non-human primates A non-human primate (NHP) model was used to determine a surrogate of protection • The NHP model mimics many aspects of human diseas
Slide 10: VLA1553-303: Long-term follow-up clinical trial
VLA1553-303: Long-term follow-up clinical trial Designed to evaluate antibody persistence and long-term safety of VLA1553 VLA1553-3031 is an open-label phase 3b, single-arm trial 363 participants rolled over from the pivotal Phase 3 clinical trial VLA1553-3012 Primary objective: Evaluate persi
Slide 11: VLA1553-303: Demographic Data
VLA1553-303: Demographic Data Baseline characteristics were similar across age groups 18-64 Years >=65 Years All Participants N=310 N=53 N=363 Sex n (%) Female 177 (57.1) 30 (56.6) 207 (57.0) Male 133 (42.9) 23 (43.4) 156 (43.0) Race n (%) American Indian or Alaskan Native 2 (0.6) 0 2 (0.6) Asian 6
Slide 12: VLA1553-303: Seroresponse in 97% of Participants Retained After 24 Months
VLA1553-303: Seroresponse1 in 97% of Participants Retained After 24 Months Data support the anticipated long-term durability of the immune response after a single dose VLA1553, Whole Sample Population 99% 98% 99% 97% 100% 80% Month 24: Sero- 60% SRR 97% (306 / 316) response 95%CI: 94.3 – 98.5 Rate 4
Slide 13: VLA1553-303: Comparable Titers Retained in Participants 18-64 or ≥65 Years
VLA1553-303: Comparable Titers Retained in Participants 18-64 or ≥65 Years In older adults aged ≥ 65 years, antibody persistence was similar as in younger adults 18-64 years (N = 310) ≥65 years (N = 53) 10 000 3 537 3 568 Seroresponse Seroresponse 1 031 892 1 056 1 055 CHIKV-Specific 757 949 CHIKV-S
Slide 14: VLA1553-303: Serious Adverse Events from Month 6 until Year 2
VLA1553-303: Serious Adverse Events from Month 6 until Year 2 No SAE deemed related to VLA1553 administration System Organ Class 18-64 Years >=65 Years All Subjects Preferred Term [n (%) m] N=310 N=53 N=363 Serious AEs (SAEs): results in death (including fetal death), life threatening, Any SAE 6 (1.
Slide 15: VLA1553-303 Summary
VLA1553-303 Summary The results from VLA1553-303 are in line with expectations for live-attenuated vaccines, which are known to induce long-lasting immunity after a single dose. 24 months after the single-dose vaccination, 97% of participants retained neutralizing antibody titers above the serorespo
Slide 16: Acknowledgements
Acknowledgements + Trial Participants, Clinical Trial Sites and Vendors + Valneva VLA1553 Project Team and Clinical Trial Teams + Herwig Kollaritsch, Lin Chen, Eva-Maria Poellabauer, DSMB Committee + Najwa Khuri-Bulos, SPEAC (Safety Platform for Emerging Vaccines) DSMB Observer + Development of VLA1
Slide 17: Thank you
Thank you Merci Danke Tack valneva