-US-based clinical-stage biotechnology company Novavax (NASDAQ: NVAX) has 
called upon the expertise of Australian based Nucleus Network (Nucleus) to 
commence Phase 1 clinical trials for its COVID-19 vaccine trials.-

The first COVID-19 vaccine to be tested outside of the USA, and only the third 
vaccine clinical trial in the world, will be conducted by Australia's largest 
Phase 1 clinical trials specialist Nucleus Network.

As part of the urgent global race to develop a vaccine to tackle the 
Coronavirus COVID-19 outbreak, Nucleus is due to commence Phase 1 testing for 
the Novavax SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, 
NVX-CoV2373, at its Melbourne and Brisbane clinics within the coming weeks.

"Nucleus has a rich history of Phase 1 vaccine trials, and a long-standing 
track-record with Novavax; we are well positioned to implement rapid testing 
with first-in-human trials over the coming weeks," says Nucleus CEO Cameron 
Johnson. 

"With the capacity to conduct this trial across both our Melbourne and Brisbane 
clinics, we will be assisting Novavax to undertake Phase 1 trials and fast 
track NVX-CoV2373 to potential subsequent development as soon as possible," 
adds Johnson.

Novavax's early development efforts on vaccines for two other recent 
coronavirus epidemics - severe acute respiratory syndrome (SARS) and Middle 
East respiratory syndrome (MERS), along with prior work on Ebola (phase 1 trial 
conducted in Australia) - allows them to leverage their understanding of 
coronaviruses and adapt their research to create a vaccine for SARS-CoV-2, the 
virus that causes COVID-19.

"The urgent global race to develop a vaccine against the COVID-19 pandemic 
drove our rapid identification and selection of an optimal, highly immunogenic 
vaccine candidate," said Stanley C. Erck, President and CEO of Novavax. "We are 
pleased that Nucleus, our long-time partner, was able to accommodate our 
accelerated timeline."

The Phase 1 trial of NVX-CoV2373 is expected to begin in mid-May with 
preliminary immunogenicity and safety results in July. 

The scale and absolute commitment to the highest standards make Nucleus the 
ideal partner in the rapid development of the vaccine for COVID-19. 

"We own 150 of the total 250 dedicated phase I beds available in Australia over 
two sites in Melbourne and Brisbane, located within major medical precincts. 
Supported by our workforce of over 400 specialists, we are in the unique 
position of offering sponsors a multi-site pathway to conduct their clinical 
trials," says Johnson.

This scale allows Nucleus to address the urgency of the COVID-19 vaccine 
studies, without interruption to other ongoing clinical trials. The standards 
ensure the reliability of the studies, especially in the current pandemic 
situation across the world.

"For all of our clinical trials, Nucleus has implemented the highest level of 
Transmission-Based Precautions within its clinical units including the creation 
of dedicated teams of clinical staff," says Nucleus Infectious Diseases 
Physician and Microbiologist and, Associate Professor of Medicine at the 
University of Queensland, Dr Paul Griffin. "These staff are assigned to work 
only in functional designated areas and there is no cross-pollination of these 
teams, improving safety, reducing study risk, and ensuring integrity of the 
trials."

As a key partner in the development of these promising vaccine candidates, 
Nucleus' role in solving the current pandemic is top of mind for Johnson. 

"As COVID-19 continues to impact the everyday life of all global citizens, 
finding a solution has become an urgent objective for governments and health 
organisations around the world. The world is watching and we're on the front 
line, supporting Novavax to unlock the potential of a Coronavirus COVID-19 
vaccine."  

Additional resources: https://nucleusnetwork.com.au/news/covid-19

About Nucleus Network

Nucleus Network is the only multi-site phase I clinical trials provider located 
in Australia and the USA. Nucleus Network provides high-quality, first-in-human 
and early-phase trials for biotechnology and pharmaceutical companies across 
the USA, Europe and Asia. Located within cutting-edge health precincts, Nucleus 
Network's cost-effective, accelerated clinical development solutions are 
supported by advanced technology, clinical excellence, and research expertise.

About Novavax

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 
and address urgent, global health needs. Novavax recently initiated development 
of a vaccine program against COVID-19, with human results expected in July of 
2020. Novavax is a leading innovator of recombinant vaccines; its proprietary 
recombinant technology platform combines the power and speed of genetic 
engineering to efficiently produce a new class of highly immunogenic 
nanoparticles addressing urgent global health needs.

For interview: 
Dr Paul Griffin, Nucleus Infectious Diseases Physician and Microbiologist and, 
Associate Professor of Medicine at the University of Queensland
Cameron Johnson, CEO, Nucleus Network

All media enquires:
Ric Navarro, Vice President, Marketing & Business Development
r.navarro@nucleusnetwork.com.au
+61 4 31 658 476

Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road
Melbourne, VIC, 3004, Australia
w: nucleusnetwork.com.au

SOURCE: Nucleus Network