Australia's largest Phase 1 Clinical trials specialist, Nucleus Network, has 
today commenced dosing the first human participants for the Phase 1/2 trial of 
NVX-CoV2373, a SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, 
at its Melbourne clinic.

Nucleus Network has begun the Phase 1/2 COVID-19 vaccine trial in Australia on 
behalf of Novavax, Inc., the developer of NVX-CoV2373 and sponsor of the trial, 
with funding support from the Norway-based Coalition for Epidemic Preparedness 
Innovations (CEPI), joining the global response to this pandemic. 

Victorian Parliamentary Secretary for Medical Research, The Hon. Frank McGuire, 
formally launched the Novavax trial with Nucleus Network in Melbourne today, 
saying this was a significant step forward in the race for a vaccine.

"Vaccines are one of mankind's greatest achievements in saving lives and 
livelihoods," Mr. McGuire said. "As the first human trial in the southern 
hemisphere, and one of only a handful of COVID-19 human trials worldwide, I am 
delighted Victoria is again at the forefront in leadership and excellence in 
medical research. The combination of expertise, institutional clout and 
commitment is vital in the race for a reliable, safe, and effective vaccine. We 
hope these trials make a significant contribution to the discovery of a vaccine 
that would ultimately benefit hundreds of millions of people around the world."

Nucleus Network Melbourne is initiating the Phase 1 portion of the Phase1/2 
trial with additional dosing to commence at its Brisbane clinic within the 
week. Approximately 130 healthy participants, aged 18 to 59 years of age, in 
Melbourne and Brisbane have been screened to take part in this portion of the 
Novavax trial. The trial will be under the guidance of leading medical experts 
in clinical trials including Nucleus Network Chief Medical Officer, Dr Jason 
Lickliter and Nucleus Network Infectious Diseases Physician and Microbiologist 
Dr Paul Griffin.

NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology and 
contains Novavax' patented saponin-based Matrix M™ adjuvant to enhance the 
immune response and stimulate high levels of neutralizing antibodies. This is 
considered a critical aspect for effective vaccine protection and offers a 
promising avenue for vaccine development.

Novavax received the largest investment to date given by CEPI, up to USD$388 
million, to advance NVX-CoV2373, through Phase 2 clinical trials and 
rapidly scale-up manufacturing capacity.

"Novavax responded rapidly to the COVID-19 pandemic to create an optimal 
vaccine candidate and quickly advance it into a Phase 1 clinical trial," said 
Stanley C. Erck, President and Chief Executive Officer of Novavax. "We thank 
our employees and partners, including Nucleus, who continue to work tirelessly 
to advance this important research and the trial participants who have 
volunteered for the benefit of many others around the world."

Nucleus Network will be leveraging its considerable expertise in delivering 
clinical trials by recruiting and supporting participants in the trial at the 
company's Melbourne and Brisbane purpose-built facilities.

"As Australia's largest Phase 1 clinical trials specialist, we have a rich 
history of delivering Phase 1 vaccine trials, and a long-standing track record 
with Novavax," says Nucleus Network Infectious Diseases Physician and 
Microbiologist Dr Paul Griffin. "This trial offers the first critical step into 
creating a potential vaccine that is safe and able to be accelerated into the 
next phase of development."

With extensive COVID-19 safety measures in place to cover its clinical 
operations and participant recruitment, Nucleus Network continues to 
successfully deliver Phase 1 clinical trials during the current pandemic. "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 Network CEO Cameron 
Johnson. "These staff are assigned to work only in functional designated areas 
and there is no cross-pollination of these teams, improving safety for our 
staff and participants, reducing study risk, and ensuring integrity of the 
trials."

"The decision from Novavax to select Nucleus Network is a significant milestone 
for the Australian clinical trials ecosystem," says Johnson. "We still have a 
long way to go, but we're proud to be a part of the team to deliver a safe, 
effective, and globally accessible vaccine as quickly as possible." 

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About Nucleus Network

Nucleus Network is the only multi-site Phase 1 clinical trials provider located 
in Australia and the USA. We provide 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, our 
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 NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that 
causes COVID-19, with Phase 1 clinical trial results expected in July. 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.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and 
civil society organizations, launched at Davos in 2017, to develop vaccines to 
stop future epidemics. CEPI has moved with great urgency and in coordination 
with WHO in response to the emergence of COVID-19. CEPI has initiated 9 
partnerships to develop vaccines against the novel coronavirus. The programs 
will leverage rapid response platforms already supported by CEPI as well as new 
partnerships. The aim is to advance COVID-19 vaccine candidates into clinical 
testing as quickly as possible.

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, 
Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift 
Valley Fever and Chikungunya virus. CEPI also invested in platform technologies 
that can be used for rapid vaccine and immunoprophylactic development against 
unknown pathogens (Disease X).

For Interview

- Dr Paul Griffin, Infectious Diseases Physician and Microbiologist, Nucleus 
Network 
- Dr Jason Lickliter, Chief Medical Officer, Nucleus Network 
- Note: Due to privacy protocols, trial participants are not available for 
media interviews, however footage of the vaccine dosing-where participants are 
de-identified-will be available.

Additional media resources including B-roll footage

https://nucleusnetwork.com.au/presskit/ 
https://app.box.com/v/NovavaxNucleusMediaKit (Dosing footage uploaded (2-4pm) 
Tuesday 26th May)

SOURCE  Nucleus Network