Novavax Inc 8-K, filed Apr 20, 2022
Novavax Inc (NVAX)
About this 8-K
Novavax Inc filed this 8-K on April 20, 2022.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
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Washington, D.C. 20549
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CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On April 20, 2022, Novavax, Inc. (the “Company”) provided an update for investors at the World Vaccine Congress presenting information relating to initial results from the Company’s COVID-19-Influenza Combination Vaccine candidate (“CIC”) trial (the “Investor Presentation”), which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. The Company’s CIC combines NVX-CoV2373, the Company’s coronavirus vaccine candidate, and NanoFlu, the Company’s quadrivalent influenza vaccine candidate. NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by the Company. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season. A copy of the Investor Presentation will also be accessible on the Company’s website at www.novavax.com under “Investors/Events & Presentation.” A copy of the press release announcing the initial results from the Company’s CIC trial (the “Press Release”) is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of the Company’s website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on the Company’s website to be part of this Current Report on Form 8-K.
Cautionary Note Regarding Forward-Looking Statements. The Investor Presentation and the Press Release contain forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. Please refer to the cautionary notes in the Investor Presentation and the Press Release regarding these forward-looking statements.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Investor Presentation of Novavax, Inc. | |
| 99.2 | Press Release, dated April 20, 2022, regarding the announcement of initial results from the Company’s COVID-19-Influenza Combination Vaccine Candidate trial. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Novavax, Inc. | ||
| Date: April 20, 2022 | By: | /s/ John A. Herrmann III |
| Name: | John A. Herrmann III | |
| Title: | Executive Vice President, Chief Legal Officer and Corporate Secretary | |
Exhibit 99.1
1 © 2022 NOVAVAX. All rights reserved. UPDATE ON NOVAVAX INVESTIGATIONAL N anoFlu VACCINE AND COVID - 19 - INFLUENZA COMBINATION VACCINE DEVELOPMENT VIVEK SHINDE, MD APRIL 20, 2022 | NOVAVAX
SAFE HARBOR STATEMENT 2 © 2022 NOVAVAX. All rights reserved. Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX - CoV 2373 , including Novavax’ plans to initiate a pediatric study in Q 2 2022 , NanoFlu, its COVID - seasonal influenza investigational vaccine candidate, COVID - NanoFlu combination vaccine, including Novavax’ plans to initiate a Phase 2 clinical trial for COVID - NanoFlu combination vaccine, Omicron - specific vaccine, and other Novavax vaccine product candidates, the timing of results from clinical trials, the potential impact of Novavax and NVX - CoV 2373 in addressing vaccine access, controlling the pandemic and protecting populations, including the potential for a booster dose of NVX - CoV 2373 to provide protection against COVID - 19 (including variants), and the efficacy, safety, and intended utilization of NVX - CoV 2373 , the scope, timing, and outcome of future regulatory filings and actions, including Novavax' plans to supplement global regulatory filings with the pediatric data and pediatric investigations plans agreed to by regulatory authorities, the global market opportunities for NVX - CoV 2373 , the readiness of our global supply chain and future availability of NVX - CoV 2373 at a global scale and the commercialization and expected delivery of NVX - CoV 2373 , and key upcoming milestones constitute forward - looking statements . Forward - looking statements may generally contain words such as “believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “indicate,” “plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume” or variations of such words or other words with similar meanings . Novavax cautions that these forward - looking statements are subject to numerous assumptions, risks and uncertainties that change over time and may cause actual results to differ materially from the results discussed in the forward - looking statements . These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities ; difficulty obtaining scarce raw materials and supplies ; resource constraints, including manufacturing capacity, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways ; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities ; and those other risk factors identified in the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax' Annual Report on Form 10 - K for the year ended December 31 , 2021 , as filed with the Securities and Exchange Commission, which are available at www . sec . gov and www . novavax . com . Forward - looking statements are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance . Current results may not be predictive of future results . You should not place considerable reliance on forward - looking statements which speak only as of the date hereof . The Company does not undertake to update or revise any forward - looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law . Novavax TM (and all associated logos) is a trademark of Novavax, Inc . Matrix - M TM is a trademark of Novavax AB .
OVERVIEW NanoFlu ( qNIV ) Vaccine Program Development COVID - Influenza Combination (CIC) Vaccine Development 3 © 2022 NOVAVAX. All rights reserved.
N anoFlu * ( q NIV ) VACCINE DEVELOPMENT 4 © 2022 NOVAVAX. All rights reserved. * NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019 - 2020 influenza season.
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. All rights reserved. 1. Diaz - Granados 2015; 2. Dunkle , 2017; 3. Zost , 2017; 4. Cowling 2019; 5. Izurieta 2019; 6. Frey 2014; 7. Mannino 2012; 8. Gouma 2020; 9. Shinde 2018; 10. Shinde 2020 NanoFlu ( qNIV ) has been shown to induce BOTH broadly cross - reactive antibodies AND potent polyfunctional CD4+ T - cell responses AND avoids egg - adaptive antigenic changes These are product characteristics only and no head - to - head studies have been done and are not meant to imply clinical efficacy.
6 © 2022 NOVAVAX. All rights reserved.
AIMS • Demonstrate immunologic non - inferiority to licensed influenza vaccine ( Fluzone Quadrivalent) on 4 homologous strains • Establish pivotal clinical trial dataset to support filing of BLA via accelerated approval path PHASE 3: A NON - INFERIORITY IMMUNOGENICITY TRIAL Primary objectives: • Demonstrate non - inferior immunogenicity of NanoFlu vs. 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, μg (H1N1/H3N2/B V /B Y ) Matrix - M1 Adjuvant Dose, µg 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. Lancet Infectious Dis. 2021. DOI:10.1016/S1473 - 3099(21)00192 - 4 © 2022 NOVAVAX. All rights reserved. 7 DESIGN • 2650 adults ≥65 years of age, across 19 US sites • Randomized to 1:1 to either NanoFlu or Fluzone Quadrivalent • Stratified by receipt of prior year seasonal influenza vaccine • Single dose of test vaccine on Day 0 Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
• Primary immunogenicity endpoint met on all homologous strains assessed with egg - adapted HAI antibody responses • GMT ratio and seroconversion difference success criteria met for non - inferiority • NanoFlu : 24 — 66% higher wild - type HAI antibody responses vs Fluzone quadrivalent against 4 homologous strains • NanoFlu : 34 — 46% higher wild - type HAI antibody responses vs Fluzone quadrivalent against 6 A/H3N2 drift strains • Wild - type microneutralization antibody responses confirmed wild - type HAI antibody responses PHASE 3 SUMMARY: PRIMARY ENDPOINT MET Shinde et al. Lancet ID. 2021. DOI: 10.1016/S1473 - 3099(21)00192 - 4 © 2022 NOVAVAX. All rights reserved. 8
PHASE 3 CMI: POTENT INDUCTION OF POLYFUNCTIONAL CD4+ T CELL RESPONSES RCD plot of Day 0 and 7 counts of double cytokine+ effector CD4+ T cells against A/Kansas (H3N2) 9 © 2022 NOVAVAX. All rights reserved. • qNIV right shifted distribution • Virtually all qNIV participants became “ CMI responders ,” including those with low baseline • Similar pattern of CMI responses seen for triple and quadruple cytokine+ responses, and against B/Maryland (B - Vic) Shinde et al. Lancet ID. 2021. DOI: 10.1016/S1473 - 3099(21)00192 - 4
Day 7, 28, 364 geometric mean fold rise (GMFRs) relative to Day 0, of double cytokine+ effector CD4+ T cells against A/Kansas (H3N2), B/ Marylan (B - Vic), A/Cambodia (drifted H3N2), or A/Wisconsin (drifted H1N1) 10 © 2022 NOVAVAX. All rights reserved. PHASE 3 CMI: KINETICS OF EFFECTOR CD4+ T CELL RESPONSES OVER 1 YEAR GMFR 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad NanoFlu Fluzone Quad Day 7 Day 28 Day 364 Day 7 Day 28 Day 364 Day 7 Day 28 Day 364 Day 7 Day 28 Day 364 A/Kansas (H3N2) B/Maryland (B-Vic) A/Cambodia (Drifted H3N2) A/Wisconsin (Drifted H1N1) qNIV induced higher fold - rises of CD4+ T cells as compared to Fluzone against homologous and drifted strains and these responses remained elevated at 1 year Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
PHASE 3: SUMMARY AND CONCLUSIONS Primary endpoint met: • Demonstrated immunologic non - inferiority to Fluzone Quad (egg - adapted HAI antibody responses) Statistically significant higher wild - type HAI antibody responses compared to Fluzone Quadrivalent: • 24 — 66% improved Day 28 GMTs against homologous strains • 34 — 46% improved Day 28 GMTs against multiple drifted A/H3N2 strains Wild - type neutralizing antibody responses corroborated wild - type HAI antibody responses, including against drift strains Potent induction of polyfunctional CD4+ T - cell responses, with persistence one year later • Virtually all NanoFlu subjects became “CMI responders”, including, notably, those with low baseline CMI 11 © 2022 NOVAVAX. All rights reserved. Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
COVID - INFLUENZA COMBINATION (CIC) VACCINE DEVELOPMENT 12 © 2022 NOVAVAX. All rights reserved.
RATIONALE FOR A COVID - INFLUENZA COMBINATION VACCINE RECURRENT BOOSTERS OF A SARS - COV - 2 VACCINE MAY BE NEEDED IN FUTURE Ongoing potential for emergence of variants escaping natural/vaccine immunity Continued SARS - CoV - 2 circulation , potentially in a seasonally recurrent pattern Waning of neutralizing antibody responses in the 4 to 12 months following vaccination or infection THERE IS AN ONGOING NEED FOR ANNUAL SEASONAL INFLUENZA VACCINATION Despite little influenza transmission during the COVID - 19 pandemic in 2020 and 2021, influenza transmission likely to rebound in 2022 and beyond with reopening of society Continued urgent public health need to develop more effective seasonal influenza vaccines © 2022 NOVAVAX. All rights reserved. 13 ADDRESS TWO MAJOR PUBLIC HEALTH PROBLEMS WITH ONE POTENTIAL VACCINE SOLUTION Development of combination vaccine anticipates future need to annually immunize against both SARS - CoV - 2 and influenza virus in advance of the winter transmission season
The study will evaluate dose ranges for both Spike and Hemagglutinin antigens, using a Design of experiments (DoE) approach with 14 treatments groups Key antibody and cell - mediated immunity responses will be used to select one or more doses to advance into further development Participants are administered the reference formulation of a single vaccine, at the dose level evaluated in previous Phase III trials A NOVEL DOSE FINDING STUDY DESIGN USING A DESIGN OF EXPERIMENTS (DoE) APPROACH Phase I/II Study © 2022 NOVAVAX. All rights reserved. 14
640 adults aged 50 – 70 years , seropositive by infection or vaccination ≥ 8 week prior 2 doses of various CIC formulations, 56 days apart rS dose range 2.5 - 22.5 μ g/dose HA dose range 5 - 60 μ g/strain/dose Matrix - M adjuvant dose : 50 μ g/dose Safety and reactogenicity: through Day 70 and 182 Immunogenicity (Anti - S IgG and HAI): Day 0, 28 , 56, 70 Cell mediated immune (CMI) responses: Day 0, 7, 63 Assess safety and reactogenicity of various COVID - 19 Influenza combination (CIC) vaccine formulations Assess immunogenicity of various CIC formulations Optimize HA and rS dose selection for combo vaccine NOVEL DOSE FINDING STUDY DESIGN USING A DESIGN OF EXPERIMENTS (DOE) APPROACH Phase I/II Study Study Design Vaccine Group N Day 0 Day 56 ( “ 4 days) HA Dose per Strain, μ g rS, μ g Matrix - M, μ g HA Dose per Strain, μ g rS, μ g Matrix - M, μ g ICC vaccine formulations A 40 60 22.5 50 60 22.5 50 B 40 10 7.5 50 10 7.5 50 C 40 60 22.5 50 60 22.5 50 D 40 10 7.5 50 10 7.5 50 E 40 10 22.5 50 10 22.5 50 F 40 35 7.5 50 35 7.5 50 G 40 5 22.5 50 5 22.5 50 H 40 60 2.5 50 60 2.5 50 I 40 5 7.5 50 5 7.5 50 J 40 5 2.5 50 5 2.5 50 K 40 35 22.5 50 35 22.5 50 L 40 35 2.5 50 35 2.5 50 M 40 60 7.5 50 60 7.5 50 N 40 60 2.5 50 60 2.5 50 qNIV with Matrix - M adjuvant reference formulation O 1 40 60 0 75 0 5 50 SARS - CoV - 2 rS with Matrix - M adjuvant reference P 40 0 5 50 0 5 50 Total 640 DESIGN OBJECTIVES 15 Note: 1 Participants from treatment Vaccine Group O will receive an additional dose of 5μg SARS - CoV - 2 rS with 50μg Matrix - M1 at Day 70; HA = hemagglutinin; rS = recombinant spike protein; qNIV = quadrivalent hemagglutinin nanoparticle influenza vaccine © 2022 NOVAVAX. All rights reserved.
16 PRELIMINARY RESULTS OF PHASE 1/2 CIC VACCINE TRIAL © 2022 NOVAVAX. All rights reserved.
BASELINE CHARACTERISTICS, REACTOGENICITY AND SAFETY RESULTS 17 © 2022 NOVAVAX. All rights reserved. Treatment groups were comparable at baseline • Median age 59 years • 62% male / 38% female • 100% had received prior primary series EUA COVID - 19 vaccine; median 10.7 weeks prior to Day 0 • ~0.2% had been previously infected with SARS - CoV - 2 CIC formulations were well tolerated with: • Comparable reactogenicity to standalone reference rS (NVX - CoV2373) and HA ( qNIV ) formulations • Most common solicited local AEs were pain and tenderness • Most common solicited systemic AEs were fatigue, headache, malaise, muscle pain; fever was rare • Generally Grade 0, 1 or 2 . 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. All rights reserved. 1,000 10,000 100,000 Day 0 28 HA 0 μ g (Ref) 1,000 10,000 100,000 Day 0 28 HA 60 μ g 1,000 10,000 100,000 Day 0 28 HA 35 μ g 1,000 10,000 100,000 Day 0 28 HA 10 μ g 1,000 10,000 100,000 Day 0 28 HA 5 μ g rS 22.5 μ g rS 2.5 μ g rS 7.5 μ g rS 5.0 μ g ANTI - S IgG DOSE RESPONSE WITH INCREASING rS DOSE ACROSS ALL LEVELS OF HA DOSE Anti - Spike IgG antibody geometric mean ELISA units (GMEU) by dose and visit Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g IgG GMEU (log 10)
PEAK INFLUENZA HAI ANTIBODY DOSE RESPONSE WITH INTERMEDIATE LEVELS OF HA DOSE Hemagglutination inhibition (HAI) antibody geometric mean titers (GMT) by dose and visit – A/Brisbane H1N1 19 © 2022 NOVAVAX. All rights reserved. 20 200 Day 0 28 HA 60 μ g (Ref) 20 200 Day 0 28 HA 60 μ g 20 200 Day 0 28 HA 35 μ g 20 200 Day 0 28 HA 10 μ g 20 200 Day 0 28 HA 5 μ g rS 22.5 μ g rS 2.5 μ g rS 7.5 μ g rS 0 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 75 μ g HAI GMT (log 10)
PEAK INFLUENZA HAI ANTIBODY DOSE RESPONSE WITH INTERMEDIATE LEVELS OF HA DOSE Hemagglutination inhibition (HAI) antibody geometric mean titers (GMT) by dose and visit – A/Kansas H3N2 20 © 2022 NOVAVAX. All rights reserved. 20 200 Day 0 28 HA 60 μ g (Ref) 20 200 Day 0 28 HA 60 μ g 20 200 Day 0 28 HA 35 μ g 20 200 Day 0 28 HA 10 μ g 20 200 Day 0 28 HA 5 μ g rS 22.5 μ g rS 2.5 μ g rS 7.5 μ g rS 0 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 75 μ g HAI GMT (log 10)
PEAK INFLUENZA HAI ANTIBODY DOSE RESPONSE WITH INCREASING LEVELS OF HA DOSE Hemagglutination inhibition (HAI) antibody geometric mean titers (GMT) by dose and visit – B/Maryland (Vic) 21 © 2022 NOVAVAX. All rights reserved. 20 200 Day 0 28 HA 60 μ g (Ref) 20 200 Day 0 28 HA 60 μ g 20 200 Day 0 28 HA 35 μ g 20 200 Day 0 28 HA 10 μ g 20 200 Day 0 28 HA 5 μ g rS 22.5 μ g rS 2.5 μ g rS 7.5 μ g rS 0 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 75 μ g HAI GMT (log 10)
PEAK INFLUENZA HAI ANTIBODY DOSE RESPONSE WITH INTERMEDIATE LEVELS OF HA DOSE Hemagglutination inhibition (HAI) antibody geometric mean titers (GMT) by dose and visit – B/Phuket (Yam) 22 © 2022 NOVAVAX. All rights reserved. 20 200 Day 0 28 HA 60 μ g (Ref) 20 200 Day 0 28 HA 60 μ g 20 200 Day 0 28 HA 35 μ g 20 200 Day 0 28 HA 10 μ g 20 200 Day 0 28 HA 5 μ g rS 22.5 μ g rS 2.5 μ g rS 7.5 μ g rS 0 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 50 μ g Matrix - M 75 μ g HAI GMT (log 10)
MODELING CAN PREDICT AN OPTIMAL DOSE OF rS AND HA Design of experiments (DoE) response surface modeling methods 23 © 2022 NOVAVAX. All rights reserved. 3 separate multiple regression modeling approaches were employed. Each approach: • Constructed 5 separate second order models ( ie , main rS and HA dose effects, quadratic of rS and HA dose, and interaction terms) • One model each for the Day 28 (post - first dose) antibody response to each strain : SARS - CoV - 2 IgG and each of the 4 homologous flu strain HAI responses • Considered different covariates : age, sex, BMI, baseline IgG or HAI, time since EUA COVID - 19 vaccine, and EUA vaccine brand • Produced an antibody response “surface” for each antibody measure ; imagine a 3 - D shape, could be a hill, a valley, a saddle, etc. • 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. All rights reserved. • We used these models to predict the impact of every permutation of combinations of HA dose and rS dose on the IgG and HAI response, and then compared the predicted responses versus reference standalone HA and rS responses • As an example, selected output is shown below for permutations of combinations of rS 25 μ g with HA dose level ranging from 24 - 34 μ g that produce optimal HAI and IgG responses comparable to the reference standalone • Across a range of sample dose levels shown, responses closely match or exceed reference values for H1N1, H3N2, B - Vic, IgG HA dose ( μ g) rS dose ( μ g) Predicted A/Bris H1N1 Reference A/Bris H1N1 Predicted A/Kans H3N2 Reference A/Kans H3N2 Predicted B/MD B - Vic Reference B/MD B - Vic Predicted B/Phu B - Yam Reference B/Phu B - Yam Predicted IgG Reference IgG 24 25 126.7 133.9 134.2 145.1 62.4 65.8 61.7 100.8 15,778 16,818 25 25 127.5 133.9 136.5 145.1 62.8 65.8 62.3 100.8 15,693 16,818 26 25 128.3 133.9 138.7 145.1 63.2 65.8 62.8 100.8 15,606 16,818 27 25 129.1 133.9 140.8 145.1 63.6 65.8 63.3 100.8 15,518 16,818 28 25 129.8 133.9 142.7 145.1 64.0 65.8 63.9 100.8 15,428 16,818 29 25 130.6 133.9 144.6 145.1 64.4 65.8 64.4 100.8 15,337 16,818 30 25 131.3 133.9 146.3 145.1 64.7 65.8 64.9 100.8 15,244 16,818 31 25 132.0 133.9 147.9 145.1 65.1 65.8 65.4 100.8 15,150 16,818 32 25 132.7 133.9 149.3 145.1 65.4 65.8 65.9 100.8 15,055 16,818 33 25 133.4 133.9 150.6 145.1 65.8 65.8 66.3 100.8 14,958 16,818 34 25 134.0 133.9 151.7 145.1 66.1 65.8 66.8 100.8 14,859 16,818
USING MODELING TO PREDICT AN OPTIMAL DOSE OF rS AND HA Design of experiments (DoE) response surface modeling for dose optimization 25 © 2022 NOVAVAX. All rights reserved. The 3 different modeling approaches broadly converged on a similar set of results with regards to optimal dose combinations, increasing the robustness of the overall interpretation and conclusions: • Both rS and HA antigens as a combined formulation modestly interfere with each other, however, interference can be overcome with dose adjustment • Higher rS dose levels (>20 μ g) can overcome the interference of HA dose, and can match (standalone) reference rS vaccine responses • Intermediate dose levels of HA (24 - 40 μ g per strain) can overcome the interference of rS dose, and can match (standalone) reference HA responses for H3N2, H1N1, B - Vic strains; but modestly lower for B - Yam strain
PRELIMINARY FINDINGS AND NEXT STEPS 26 © 2022 NOVAVAX. All rights reserved. • The first study to demonstrate that a COVID - Influenza combination vaccine is feasible, well - tolerated, and immunogenic , and these data warrant continued development • A novel DoE modeling - based approach to dose finding/optimization is a powerful tool that may allow : • Granular resolution of immune responses across a response surface, and • Fine - tuned dose selection • Various CIC formulations may induce antibody responses comparable to the standalone qNIV and COVID - 19 vaccine formulations (for H1N1, H3N2, B - Vic, and rS ) • Higher rS dose needed in CIC than standalone rS • Lower dose of HA needed in CIC than standalone HA • Implies up to 50% reduction in total antigen content in the CIC formulation compared to the sum of standalone rS and HA components – potentially dose sparing
PRELIMINARY FINDINGS AND NEXT STEPS 27 © 2022 NOVAVAX. All rights reserved. • This study evaluated CIC formulations with 50μg of Matrix - M adjuvant, which was lower than the 75μg Matrix - M previously used in the standalone qNIV • A higher Matrix - M adjuvant dose of 75μg in CIC might further enhance antibody responses, and lead to further dose sparing. To be evaluated in future trial. • Additional immunogenicity data are expected on microneutralization antibody and CMI responses, as well as 2 nd dose and durability of antibody responses • Data from this study will inform a planned Phase 2 dose confirmation study which will: • Confirm the combination vaccine dose/formulation • Assess lower doses of standalone qNIV
28 © 2022 NOVAVAX. All rights reserved. THANK YOU CONTRIBUTORS VIVEK SHINDE, WAYNE WOO, SHARON LIU, SUSAN NEAL, JOYCE PLESTED, TIM VINCENT, MINGZHU ZHU, SHANE CLONEY - CLARK, IKSUNG CHO, LOU FRIES, FILIP DUBOVSKY, GREG GLENN
29 © 2022 NOVAVAX. All rights reserved. BACKUPS
The NanoFlu vaccine Hemagglutinin nanoparticle antigen and Matrix - M adjuvant 30 © 2022 NOVAVAX. All rights reserved. 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. 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. 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 : 15µg each HA (45µg total) + 50µg Matrix - M, or • tNIV : 60µg each HA (180µg total) + 50µg Matrix - M, or • Fluzone High Dose: 60µg each HA (180µg total) Objectives/endpoints: • Day 21 wild - type HAI antibody responses against homologous and drift strains • Safety profile through 1 year 31 © 2022 NOVAVAX. All rights reserved. Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
• Demonstration of an “ adjuvant effect ” • Matrix - M adjuvant resulted in significant enhancement of immune responses when compared to unadjuvanted formulation • Higher wild - type HAI antibody responses against homologous A/H3N2 and drifted A/H3N2 strains as compared to Fluzone HD • Similar wild - type HAI antibody responses against homologous and drifted strains as compared to Flublok • Potent induction of polyfunctional CD4+ T cell responses , which were higher than both Fluzone HD and Flublok • Well - tolerated , with acceptable safety profile PHASE 2: SUMMARY © 2022 NOVAVAX. All rights reserved. Phase 2 Design: 1375 adults aged ≥65 years Randomized to 1 of 7 groups • NanoFlu: bedside mix • NanoFlu: co - formulated • NanoFlu: increased adjuvant dose (75µg Matrix - M) • NanoFlu: increased B antigen dose • NanoFlu: antigen only (no Matrix) • Fluzone HD • Flublok Objectives/endpoints: • Primary: demonstrate “adjuvant effect” • Day 28 wild - type HAI antibody responses against homologous and drift strains • Safety profile through 1 year • Exploratory: CD4+ T cell responses Shinde et al. Clin Infect Dis. 2020. DOI: 10.1093/ cid /ciaa1673 32 Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée ); Flublok (Protein Sciences Corporation)
The NanoFlu vaccine Hemagglutinin nanoparticle antigen and Matrix - M adjuvant 34 © 2022 NOVAVAX. All rights reserved. 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. 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. 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. 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. All rights reserved. 35 Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
COVID - INFLUENZA COMBINATION VACCINE DEVELOPMENT JUNE 2021 Announced data from co - administration sub - study** MAY 2021 Announced positive preclinical data* SEPTEMBER 2021 Initiated phase I/II clinical trial of COVID - NanoFlu Combination Vaccine Preclinical Development Clinical Proof of Concept • UK Phase III co - administration sub - study completed • Demonstrated viability of simultaneous COVID - 19 and influenza vaccination • Hemagglutination inhibition (HAI) and ACE2 titers were comparable between individual and combination vaccines (hamster and ferrets) • Maintained clinical and virologic protection against experimental challenge with SARS - CoV - 2 (hamster model) • Induced antibodies against SARS - CoV - 2 neutralizing epitopes common between USA - WA1 (original strain) and Beta (B.1.351) variant Clinical Development • Phase I/ II trial in Australia initiated and fully enrolled − Safety, immunogenicity, and dose finding 36 KEY MILESTONES © 2022 NOVAVAX. All rights reserved. 36 Source: * Massare et al. 2021; DOI: 10.1101/2021.05.05.442782 ,** Toback et al. 2021; DOI: 10.1101/2021.06.09.21258556
PHASE 3 IMMUNOGENICITY: PRIMARY ENDPOINT MET ON ALL HOMOLOGOUS STRAINS Day 28 egg - based or wild - type HAI GMTs and GMT ratios ( NanoFlu / Fluzone ) © 2022 NOVAVAX. All rights reserved. 37 NanoFlu Fluzone Quad D28 GMT Ratio Assay Strain D28 GMT D28 GMT ( NanoFlu / Fluzone ) 95% CI HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15) A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27) B/Maryland/15/2016 (Vic) (Homologous) 110.7 106.3 1.03 ( 0.99, 1.07) B/Phuket/3073/2013 (Yam) (Homologous) 168.5 133.9 1.23 ( 1.16, 1.29) HAI: WT A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 76.6 62.7 1.24 ( 1.17, 1.32) A/Kansas/14/2017 (H3N2) (Homologous) 153.6 90.7 1.66 ( 1.53, 1.79) B/Maryland/15/2016 (Vic) (Homologous) 62.8 47.2 1.32 ( 1.26, 1.39) B/Phuket/3073/2013 (Yam) (Homologous) 118.3 78.4 1.47 ( 1.40, 1.55) • GMT ratio success criteria met for non - inferiority • NanoFlu : 3 — 23% increased using egg - based HAI • NanoFlu : 24 — 66% increased using wild - type HAI, a more biologically and clinically relevant measure Success criteria: All 95% CI lower bounds are ≥ 0.67 Shinde et al. Lancet ID. 2021; DOI: 10.1016/S1473 - 3099(21)00192 - 4 Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée )
PHASE 3 CMI: COMPARISON TO ENHANCED INFLUENZA VACCINES IN UNIV OF HK STUDY Day 7 / 0 geometric mean fold rise (GMFRs) of IFN - γ cytokine+ total CD4+ T cells against A/H3N2 or B - Victoria strain GMFR at Day 7 NanoFlu induced substantially higher fold - rises of IFN - γ + 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. All rights reserved. Fluzone (Sanofi Pasteur Limited / Sanofi Pasteur Limitée ); Flublok (Protein Sciences Corporation) FLUAD (Seqirus, Inc.)
PHASE 1: EGG - ADAPTED REAGENTS MAY GIVE A MISLEADING RESULT Microneutralization antibody responses (GMFRs) against egg - adapted vs. wild - type A/Singapore A/H3N2 virus 39 © 2022 NOVAVAX. All rights reserved. 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 180µg NanoFlu IIV3-HD 180µg 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. All rights reserved. 40 *No SAEs in either treatment group were assessed by study investigators as related to vaccine at either timepoint. Through Day 365 NanoFlu Fluzone Quad (SD) N 1333 1319 Counts (%) of Subjects with Events Any treatment emergent adverse event ( TEAE) 783 (58.7) 697 (52.8) Any Solicited TEAE 551 (41.3) 420 (31.8) Local solicited 372 (27.9) 243 (18.4) Severe local solicited 8 ( 0.6) 2 ( 0.2) Systemic Solicited 369 (27.7) 292 (22.1) Severe systemic solicited 15 ( 1.1) 11 ( 0.8) Unsolicited TEAE 469 (35.2) 466 (35.3) Severe unsolicited 75 ( 5.6) 59 ( 4.5) Severe & related unsolicited 10 ( 0.8) 2 ( 0.2) Medically - attended unsolicited 353 (26.5) 354 (26.8) Serious adverse events (SAEs)* 81 ( 6.1) 78 ( 5.9) Shinde et al. Lancet ID. 2021; DOI: 10.1016/S1473 - 3099(21)00192 - 4 PHASE 3 SAFETY DATA THROUGH DAY 365
Exhibit 99.2
Initial Results from Novavax’ COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine
| • | Phase 1/2 clinical trial of COVID-19-Influenza combination vaccine candidate indicates vaccine is well-tolerated and immunogenic |
| • | Data from this combination trial will inform planned Phase 2 dose confirmation trial, scheduled to begin by the end of 2022 |
| • | Immune response confirmed in stand-alone influenza vaccine and combination vaccine with potential path forward for both |
GAITHERSBURG, Md., April 20, 2022 – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.
"We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “We’re encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19.”
The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.
The study employed descriptive endpoints, assessing safety and the immunological responses of different CIC vaccine formulations. A Design of Experiments (DOE) modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.
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Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. These data support advancement to a Phase 2 confirmation trial, expected to begin by the end of 2022.
Data from the trial were presented at the World Vaccine Congress (WVC) in Washington, DC.
Influenza Program Update
At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint. These results have previously been published in The Lancet.
Authorization in the U.S.
Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or approved for use in the U.S. by the U.S. Food and Drug Administration.
Important Safety Information for NVX-CoV2373
| • | NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients. |
| • | Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373. |
| • | Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. |
| • | Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. |
| • | NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. |
| • | The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals. |
| • | Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. |
| • | The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines. |
| • | Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients. |
| • | The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. |
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For additional safety information, including the full Summary of Product Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.
About the COVID-19-Influenza Combination Vaccine Phase 1/2 trial
The Phase 1/2 CIC vaccine trial is evaluating a combination of Novavax' recombinant protein-based NVX-CoV2373 and influenza vaccine candidates and patented saponin-based Matrix-M adjuvant in a single formulation. The trial will evaluate the safety, tolerability and immune response to the combination vaccine in 642 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be dosed on Day 0 and again at Day 56. The trial is being conducted in Australia at 10 sites. (ClinicalTrials.gov Identifier: NCT04961541)
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
About Matrix-M™ Adjuvant
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
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About Novavax’ Influenza Program
Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax' patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide.
For more information, visit www.novavax.com and connect with us on LinkedIn.
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Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, including the Phase 2 confirmation trial expected to begin by the end of 2022, the ongoing development of NVX-CoV2373, NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, and its COVID-Influenza Combination Vaccine, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373, the potential impact and reach of Novavax and its COVID-19 Influenza Combination Vaccine in protecting populations, and the efficacy, safety and intended utilization of the COVID-19 Influenza Combination Vaccine, NanoFlu, and NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
media@novavax.com
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