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Ratio of Day 21 GMTs 61% p=0.0002 3.8 3.9 3.5 2.1 0.0 1.0 2.0 3.0 4.0 5.0 180 g NanoFlu IIV3-HD 180 g NanoFlu IIV3-HD A/Singapore H3N2 (egg-adapted) A/Singapore H3N2 (wild-type) Geometric Mean Fold Titer Rise (95% CI) Ratio of Day 21 GMTs 61% p=0.0002 NanoFlu induced improved neutralization responses against wild - type vs. egg - adapted A/Singapore H3N2 viruses underscoring the problem of egg - adaptive mutations Neutralization antibody responses against wild - type circulating viruses are more clinically relevant NanoFlu well tolerated 2022 NOVAVAX.
Lancet ID. 2021; DOI: 10.1016/S1473 - 3099(21)00192 - 4 Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limit e ) PHASE 3 CMI: COMPARISON TO ENHANCED INFLUENZA VACCINES IN UNIV OF HK STUDY Day 7 / 0 geometric mean fold rise (GMFRs) of IFN - cytokine+ total CD4+ T cells against A/H3N2 or B - Victoria strain GMFR at Day 7 NanoFlu induced substantially higher fold - rises of IFN - + CD4+ T cells as compared to Fluzone HD, Flublok , or FLUAD based on comparable literature estimates 5.1 1.6 1.2 2.0 2.6 1.8 7.9 2.5 1.7 2.2 1.4 2.6 0.0 2.0 4.0 6.0 8.0 10.0 12.0 NanoFlu Fluzone Quad FluQuadri Fluzone HD Flublok Fluad NanoFlu Fluzone Quad FluQuadri Fluzone HD Flublok Fluad qNIV-E-301 Cowling et al qNIV-E-301 Cowling et al A/Kansas (E301) or A/Switzerland (Cowling) (H3N2) B/Maryland (E201) or B/Brisbane (Cowling) (B-Vic) Cowling 2019; DOI: 10.1093/ cid /ciz103 38 2022 NOVAVAX.
Aus. ("Drifted" H3N2; Clade 3C2a1b - 131K) 98.1 70.4 1.36 ( 1.28, 1.44) 168.8 111.1 1.53 (1.31, 1.79) A/Idaho ("Drifted" H3N2 - Clade 3C3a) 202.5 136.8 1.46 (1.37, 1.56) A/Tokyo ("Drifted" H3N2 - Clade 3C2a2) 78.0 54.5 1.39 (1.31, 1.48) A/Hong Kong ("Drifted" H3N2" - 2019) 192.6 107.2 1.61 (1.35, 1.90) A/Wisconsin ("Drifted" H1N1 - 2019) 78.3 70.3 1.11 (0.99, 1.24) B/Washington ("Drifted B - Victoria) 88.2 71.4 1.23 (1.18, 1.28) 390.9 233.6 1.67 (1.50, 1.87) B/Colorado (B/Maryland - like homologous strain) 185.7 142.9 1.37 (1.21, 1.55) 2022 NOVAVAX.
Lancet ID. 2021. DOI: 10.1016/S1473 - 3099(21)00192 - 4 HAI: Wild - type Microneutralization: Wild - type NanoFlu Fluzone Quad D28 GMT Ratio NanoFlu Fluzone Quad D28 GMT Ratio Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 76.6 62.7 1.24 ( 1.17, 1.32) 797.8 719.6 1.12 (1.01, 1.25) A/Kansas/14/2017 (H3N2) (Homologous) 153.6 90.7 1.66 ( 1.53, 1.79) 1244.6 694.8 1.78 (1.57, 2.03) B/Maryland/15/2016 (Homologous) 62.8 47.2 1.32 ( 1.26, 1.39) 500.8 325.3 1.52 (1.40, 1.66) B/Phuket/3073/2013 (Homologous) 118.3 78.4 1.47 ( 1.40, 1.55) 183.6 139.2 1.38 (1.26, 1.52) A/California ("Drifted" H3N2; Clade 3C2a1b - 131K) 115.0 80.6 1.41 ( 1.33, 1.50) A/Cardiff ("Drifted" H3N2; Clade 3C2a1b - 135N) 63.9 45.4 1.34 ( 1.27, 1.43) A/Netherlands ("Drifted" H3N2; Clade 3C3a) 102.3 74.7 1.38 ( 1.30, 1.46) A/So.
RSV, influenza, SARS - CoV - 2) Induction of polyfunctional T cells , including CD4+ (e.g. Ebola, influenza, SARS - CoV - 2), and CD8+ (e.g. Ebola, SARS - CoV - 2) Antigen sparing in the context of novel antigens: pandemic influenza, Ebola, and SARS - CoV - 2 antigens Day 28 wild - type HAI vs wildtype Neutralizing antibody ( NanoFlu / Fluzone ) PHASE 3 IMMUNOGENICITY: ENHANCED RESPONSES AGAINST HOMOLOGOUS AND DRIFTED A/H3N2 AND B - VICTORIA STRAINS Shinde et al.
FLUZONE - HIGH DOSE (IIV3 - HD) AGAINST 5 GENERATIONS OF ANTIGENICALLY DRIFTED A(H3N2) STRAINS Shinde et al. NEJM 2018. DOI: 10.1056/NEJMc1803554 Phase 1 design: 330 US adults aged 60 years Randomized 1:1:1 tNIV : 15 g each HA (45 g total) + 50 g Matrix - M, or tNIV : 60 g each HA (180 g total) + 50 g Matrix - M, or Fluzone High Dose: 60 g each HA (180 g total) Objectives/endpoints: Day 21 wild - type HAI antibody responses against homologous and drift strains Safety profile through 1 year 31 2022 NOVAVAX.
RSV, influenza, SARS - CoV - 2) Induction of polyfunctional T cells , including CD4+ (e.g. Ebola, influenza, SARS - CoV - 2), and CD8+ (e.g. Ebola, SARS - CoV - 2) Antigen sparing in the context of novel antigens: pandemic influenza, Ebola, and SARS - CoV - 2 antigens PHASE 1: NanoFlu ( tNIV ) INDUCED HIGHER WILD - TYPE HAI ANTIBODY RESPONSES (GMFRs) VS.
Recombinant hemagglutinin (HA) nanoparticles Produced in a Baculovirus/Sf9 insect cell system Expressed as recombinant , full - length, wild - type , uncleaved HA0 that assembles into homotrimers Purified homotrimers form higher order nanoparticle structures of 20 - 40 nm with PS - 80 Manufactured in a rapid, high - yield, high purity process Potent saponin - based Matrix - M adjuvant Purified fractions extracted as saponins from the bark of Quillaja saponaria Molina Formulated with cholesterol and phospholipid, forming cage - like particles Characterized by mechanisms of action that include: Enhancement of antigen delivery to draining lymph nodes Enhancement of activated T cell, B cell, and APC populations in draining lymph nodes Induction of functional, and broadly cross - reactive antibodies (e.g. influenza) Enhancement in peak and durability of antibody responses (e.g.
Used different methods for dose optimization , which involved simultaneously varying the rS and HA dose values and observing where that puts us on each of the 5 antibody response surfaces, to find an optimal dose level of rS and HA that maximize antibody responses to each antigen and matches reference standalone vaccine responses (red region) Multiple combinations of HA and rS dose levels that represents an optimal or desirable formulation can be considered for further development Pred Formula log(HAI) Brisbane 1.87 1.94 2.01 2.07 2.14 Response Grid Slider 2.12678 Pred Formula log(HAI) Kansas 1.6 1.7 1.9 2.0 2.2 Response Grid Slider 2.16167 Pred Formula log(HAI) Maryland 1.57 1.64 1.71 1.77 1.84 Response Grid Slider 1.81823 Pred Formula log(HAI) Phuket 1.54 1.61 1.69 1.76 1.84 Response Grid Slider 2.00346 MODELING CAN PREDICT AN OPTIMAL DOSE OF rS AND HA Design of experiments (DoE) response surface modeling for dose optimization 24 2022 NOVAVAX.
Grade 3 rare. No Grade 4. Solicited local and systemic AEs did not vary substantially by rS dose level Slightly higher solicited local AEs by increasing HA dose level Comparable reactogenicity between dose 1 and dose 2 Safety through Day 70: CIC formulations demonstrated comparable rates of unsolicited AEs to standalone reference rS and HA formulations Severe unsolicited AEs were rare; and none assessed as related to vaccine Serious AEs (SAEs) were rare; and none assessed as related to vaccine No reports of adverse event of special interest (AESIs) 18 2022 NOVAVAX.
Fluzone Quadrivalent: Day 0 and 28 egg - propagated virus HAI titers against the 4 homologous strains Describe the safety profile of both vaccines Day 0 Trial Treatment Injection Subjects Per Group Treatment Group Vaccine HA Dose per Strain, g (H1N1/H3N2/B V /B Y ) Matrix - M1 Adjuvant Dose, g Formulation A NanoFlu ( qNIV ) 60, 60, 60, 60 75 Co - form 1325 B Fluzone Quad [standard dose] 15, 15, 15, 15 N/A N/A 1325 Total Trial Subjects 2650 Shinde et al.
Characteristics Addressed VACCINE TYPE EGG - ADAPTIVE CHANGES ANTIGENIC DRIFT IMMUNOSENESCENCE ANTIBODIES T - CELLS Standard Inactivated 1,2,3,4,5 High - dose inactivated 1,3,4,5 x MF - 59 Adjuvanted 4,5,6,7 x x ? Cell - derived inactivated 5,8 ? Recombinant 2,3,4 x x x NanoFlu ( qNIV ) 9,10 [recombinant + adjuvanted] x x x x CHARACTERISTICS OF CURRENTLY LICENSED INFLUENZA VACCINES 5 2022 NOVAVAX.
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Lancet ID. 2021; DOI: 10.1016/S1473 - 3099(21)00192 - 4 PHASE 3 SAFETY DATA THROUGH DAY 365