Novavax, Inc. · NASDAQ:NVAX
Novavax — ICAAC 2014
11 slides from Novavax's conference presentation, 2014
Slide 1: Immunization of Pregnant Baboons with RSV F Nanoparticle Vaccine Protects Infant Baboons
Immunization of Pregnant Baboons with RSV F Nanoparticle Vaccine Protects Infant Baboons Challenged with Respiratory Syncytial Virus In a Comparable Manner to Palivizumab Prophylaxis R. Welliver1 Sr, J. Papin, R. Wolf1, V. Ivanov1, S. Moore1, R. Raghunadan2, H. Lu2, D. Flyer2, G. Smith2, G. Glenn2 1
Slide 2: Respiratory Syncytial Virus (RSV)
Respiratory Syncytial Virus (RSV) • Most frequent cause of infant hospitalization in the US, and causes 200,000 deaths worldwide annually1,2 • Severe disease in infancy often leads to recurrent wheezing3 • No licensed vaccine or effective antiviral • Highest rates of hospitalization and severe disea
Slide 3: Novavax Recombinant F Protein Nanoparticle Vaccine
Novavax Recombinant F Protein Nanoparticle Vaccine Clone genes into Infect Sf9 insect cells Sf9 cells express protein baculovirus with baculovirus antigens • RSV F vaccine is composed of recombinant, near‐full‐length fusion (F) glycoprotein homotrimers • Purified homotrimers spontaneously assemble i
Slide 4: Infant Baboon Model of RSV Infection: Rationale
Infant Baboon Model of RSV Infection: Rationale • Infant (28 day) baboons develop tachypnea and labored breathing following RSV challenge, like humans but unlike other NHP models • Infant baboons develop bronchiolar obstruction with exfoliated epithelial and inflammatory cells, like humans, unlike r
Slide 5: Palivizumab Passive Transfer Protocol
Palivizumab Passive Transfer Protocol Protocol End Point Assays Study Day ‐1 (infant age 27 days) IM 15mg/Kg Palivizumab or placebo Blinded Observations Day 0 Infant sedated Respiratory rate (sedated and awake) Blood, BAL collection, clinical measures BAL Total Leukocyte count, viral load 2X108 pfu
Slide 6: Maternal Immunization-Infant Challenge Protocol
Maternal Immunization‐Infant Challenge Protocol Protocol End Point Assays Mother immunized 3rd Day 0 (infant age 28 days) Blinded Observations trimester: 60µg RSV F adsorbed Infant sedated Respiratory rate to AlPO4 x 3 at 4 week Blood, BAL collection, clinical, PFT BAL Total Leukocyte count, viral l
Slide 7: Antibody Titers Present in Infants at Time of RSV Challenge
Antibody Titers Present in Infants at Time of RSV Challenge Palivizumab given Challenge Day ‐1 Maternal and Infant titers measured on Infant titers measured Day 0 Challenge Day 0 and 26 respectively 655360 655360 Maternal 163840 163840 Maternal RSV F Antibody GMT Infant 40960 40960 Palivizumab Antib
Slide 8: Palivizumab and Maternal Immunization Prevent Tachypnea in Infant Baboons Challenged with RSV
Palivizumab and Maternal Immunization Prevent Tachypnea in Infant Baboons Challenged with RSV Fold Rise in Respiratory Rate Above Baseline Palivizumab study Maternal immunization study p‐value=0.0008 p‐value=0.0001 Fold Rise, Respiratory Rate P- values were calculated using t-test from Anova. Error
Slide 9: Effect of Palivizumab and Maternal Vaccination on Viral Recovery and Total Leukocyte cells
Effect of Palivizumab and Maternal Vaccination on Viral Recovery and Total Leukocyte cells in BAL Fluid In Infants Lung Viral Load Day 5 BAL Total Leukocyte Day 5 p=0.037 p=0.12 p=0.16 p=0.041 P values were calculated using a Student’s t Test
Slide 10: Pulmonary Function Tests in Infants of Vaccinated Mothers and Untreated Controls
Pulmonary Function Tests in Infants of Vaccinated Mothers and Untreated Controls Work of Breathing Day 5 Peak Expiratory Flow Day 5 Work of breathing reduced in Peak expiratory flow rate greater in protected infants protected infants
Slide 11: Conclusions: Non-Human Primate Safety and Efficacy Study
Conclusions: Non‐Human Primate Safety and Efficacy Study • Maternal immunization provided infant baboons with antibody titers similar to those following palivizumab administration. • Maternal immunization was associated with reduced tachypnea and dyspnea in infants following RSV challenge; this redu