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NVX CoV 2373

Drug Profile

NVX CoV 2373

Alternative Names: Coronavirus vaccine - Novavax; COVID-19 vaccine - Novavax; NVX-CoV2373; NVX‑CoV2373 vaccine; SARS-CoV-2 recombinant spike protein nanoparticle vaccine; SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine - Novavax; SARS-CoV-2 rS nanoparticle vaccine

Latest Information Update: 17 May 2020

At a glance

  • Originator Novavax
  • Class Viral vaccines
  • Mechanism of Action Coronavirus spike glycoprotein modulators; Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II COVID 2019 infections

Most Recent Events

  • 11 May 2020 Novavax plans a phase I trial for COVID-2019-infections (Prevention) in Australia (IM) in May 2020 (NCT04368988)
  • 06 May 2020 Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Australia (IM) (NCT04368988)
  • 08 Apr 2020 Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Novavax

Development Overview

Introduction

NVX CoV 2373 is a coronavirus vaccine (COVID 19) candidate, being developed by Novavax for prevention against COVID-2019 infections. Novavax is using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. The company is also using its proprietary Matrix-M™ adjuvant with the coronavirus vaccine to enhance immune responses and stimulate high levels of neutralizing antibodies. Preclinical development is underway in the US. Clinical development is ongoing in Australia.

Matrix-M™ is a next-generation, patented saponin-based adjuvant, powered by a new formulation to provide a potent adjuvant effect. Saponins are steroid or triterpenoid glycosides, occurring in many plant species. In Matrix-M, purified saponin fractions are mixed with synthetic cholesterol and a phospholipid to form stable particles than can be readily formulated with a variety of vaccine antigens. Matrix-M™ stimulates the entry of antigen-presenting cells into the injection site and enhances antigen presentation in local lymph nodes thereby boosting the immune response. It induces both a cell-mediated and an antibody mediated immune response and also increases the opportunity for an immune reaction with longer duration, thereby reducing the number of vaccinations.

Company Agreements

In April 2020, Emergent BioSolutions and Novavax expanded their manufacturing and supply agreement to manufacture seasonal influenza nanoparticle vaccine. As per the terms of agreement, Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Nanovax seasonal influenza nanoparticle vaccine including large-scale production of the seasonal influenza nanoparticle vaccine. Emergent also will provide drug substance manufacturing services, including technology transfer and process validation and performance qualification to pave the way for commercial manufacturing. The agreement is an expansion of their original manufacturing and supply agreement signed in March 2020. Expanded collaboration now includes seasonal influenza nanoparticle vaccine and COVID-19 coronavirus vaccine candidate. Emergent will support Novavax’s goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program. As per the original agreement, Emergent will provide contract development and manufacturing services, supplying Novavax with coronavirus vaccine product candidate for preclinical testing and utilisation in a phase I trial. Emergent’s rapid deployment capabilities and expertise are also expected to provide Novavax scalability and capacity to produce the vaccine product for future stockpiling. [1] [2]

Key Development Milestones

In May 2020, Novavax initiated a phase I/II trial to evaluate the immunogenicity and safety of NVX CoV 2373 (SARS-CoV-2 rS) nanoparticle vaccine with or without Matrix-M adjuvant in healthy volunteers (2019nCoV-101; NCT04368988). The study will be conducted in two parts. In part 1, at least one and up to two NVX CoV 2373 constructs will be evaluated in up to two cohorts, and after an interim analysis of Part 1 data will be performed for an optional expansion to part 2. The two-part, randomised, observer-blinded, parallel, placebo-controlled trial is enrolling approximately 130 healthy subjects in Australia and expects to expand in multiple countries, including the US. First patient in the phase I portion of trial is enroled, in May 2020 [3] [4] [5] .

In preclinical results, NVX CoV 2373 demonstrated high immunogenicity, stimulated high levels of neutralising antibodies and efficient binding with receptors targeted by the SARS‑CoV‑2 wild-type virus [5] [6] .

Financing information

In May 2020, Novavax announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to an additional $US384 million to advance clinical development of NVX CoV 2373 . Novavax will use the CEPI funds to advance the drug into clinical testing. Earlier, the CEPI awarded an initial funding of $US4.4 million to finance the company's COVID-19 vaccine development in March 2020. This extended collaboration brings CEPI's total investment in NVX CoV 2373 to $US388 million, and the funding will be used to progress vaccine through phase I/II development. The funds will be also used for the process development and manufacturing of up to 100 million vaccine doses by end of 2020 [7] [5] [2] [8] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class Viral vaccines
  • Target Coronavirus spike glycoprotein
  • Mechanism of Action Coronavirus spike glycoprotein modulators; Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Phase I/II Australia IM / Injection Novavax 06 May 2020
COVID 2019 infections - Prevention Preclinical USA IM / Injection Novavax 26 Feb 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Novavax Originator USA
Novavax Owner USA
Coalition for Epidemic Preparedness Innovations Funder Norway

Scientific Summary

Pharmacodynamics

Summary

In preclinical studies, NVX CoV 2373 demonstrated high immunogenicity and stimulated high levels of neutralising antibodies. After a single immunisation, high levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralising antibodies were observed. The high microneutralisation titers seen after one dose, increased eight fold with a second dose [6] .

Future Events

Expected Date Event Type Description Updated
31 May 2020 Trial Update Novavax plans a phase I trial for COVID-2019-infections (Prevention) in Australia (IM) in May 2020 (NCT04368988) (700319239) [9] 17 May 2020

Development History

Event Date Update Type Comment
11 May 2020 Trial Update Novavax plans a phase I trial for COVID-2019-infections (Prevention) in Australia (IM) in May 2020 (NCT04368988) [9] Updated 17 May 2020
06 May 2020 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Australia (IM) (NCT04368988) Updated 17 May 2020
08 Apr 2020 Scientific Update Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Novavax [6] Updated 14 Apr 2020
06 Apr 2020 Licensing Status Emergent BioSolutions and Novavax enters into a manufacturing and supply agreement for Coronavirus vaccine [2] Updated 06 Apr 2020
26 Feb 2020 Phase Change - Preclinical Preclinical trials in COVID-2019-infections (Prevention) in USA (IM) [10] Updated 02 Mar 2020

References

  1. Emergent BioSolutions Signs Agreement with Novavax to Manufacture NanoFlu(Tm).

    Media Release
  2. Novavax Awarded Funding from CEPI for COVID-19 Vaccine Development.

    Media Release
  3. Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine.

    Media Release
  4. A 2-Part, Phase 1/2, Randomized, Observer-Blinded Study To Evaluate The Safety And Immunogenicity Of A SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Or Without MATRIX-M Adjuvant In Healthy Subjects

    ctiprofile
  5. Novavax Reports First Quarter 2020 Financial Results.

    Media Release
  6. Novavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May.

    Media Release
  7. Novavax to Receive up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing.

    Media Release
  8. CEPI expands investment in COVID-19 vaccine development.

    Media Release
  9. Novavax to Present COVID-19 Vaccine Candidate Progress in World Vaccine Congress Webinar Series.

    Media Release
  10. Novavax Advances Development of Novel COVID-19 Vaccine.

    Media Release
  11. Novavax to commence COVID-19 vaccine trial with Nucleus Network.

    Media Release
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