NovavaxInc, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading CDMO for biologics, viral vaccines and gene therapies, announced an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.
This arrangement falls under Novavax' recent US $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a US government program 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 100 million 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 utilized 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.
"We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate," said Stanley CErck, president and chief executive officer of Novavax. "We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population."
"We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax' response to this global crisis," said Martin Meeson, chief executive officer of FUJIFILM Diosynth Biotechnologies. "As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact."
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 $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).
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 (HHS), including the Centers for Disease Control and Prevention (CDC), US FDA, the National Institutes of Health (NIH), 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 neutralizing 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.