Melbourne, Australia, Tuesday 26th May, 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.”
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.
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.
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).
Mari Ericksen, Head of Marketing and Communications
Nucleus Network Pty Ltd
m: +61 434 252 695
Ric Navarro, Vice President Marketing & Business Development
Nucleus Network Pty Ltd
m: +61431 658 476