Therapy Areas: Infectious Diseases
Novavax, Fujifilm Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
27 July 2020 - - US-based vaccine developer Novavax, Inc. (NASDAQ: NVAX) and Japan-based contract development and manufacturing organisation Fujifilm Diosynth Biotechnologies have inked an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate, the companies said.

FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

This arrangement falls under Novavax' recent USD 1.6bn award by the federal government as part of Operation Warp Speed, a US government programme that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the US population.

The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100m doses of NVX–CoV2373 beginning as early as late 2020.

NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix–M adjuvant.

The batches produced at the FDB site in North Carolina will be utilised in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.

Novavax' Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May.

Novavax will announce the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August.

The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter.

The Phase 1/2 clinical trial is being supported by an up-to USD 388m funding arrangement with the Coalition for Epidemic Preparedness Innovations.

Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services, including the Centers for Disease Control and Prevention, FDA, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant secretary for Preparedness and Response); the Department of Defense.

OWS is coordinating existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.

NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence 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 contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies.

In preclinical trials, NVX–CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

A Phase 1 clinical trial of NVX–CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected to be announced during the first week of August.

The Coalition for Epidemic Preparedness Innovations is investing up to USD 388m, and Department of Defense is investing up to USD 60m of funding to advance clinical development of NVX–CoV2373.

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.

Novavax, Inc. (NASDAQ: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with preliminary immunogenicity and safety results expected to be announced during the first week of August.

NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Fujifilm Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark.

Fujifilm Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.

The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and ApolloX cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.

Fujifilm Diosynth Biotechnologies is a partnership between Fujifilm Corp. and Mitsubishi Corp.

Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products.

These products and services are based on its portfolio of chemical, mechanical, optical, electronic and imaging technologies.

For the year ended March 31, 2020, the company had global revenues of USD 21bn, at an exchange rate of 109 yen to the dollar.
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