US-based clinical-stage biotechnology company Novavax has called upon the expertise of Australian based Nucleus Network to commence Phase 1 clinical trials for the first confirmed COVID-19 vaccine trial outside of the US.
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 the first confirmed COVID-19 vaccine trial outside of the US.
MELBOURNE, Australia, April 16, 2020 /PRNewswire/ -- 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,” says Nucleus CEO Cameron Johnson. “This is the third confirmed global COVID19 vaccine trial and the first in Australia and we are well positioned to implement rapid testing with first-in-human trials over the coming weeks.
“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. 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.
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Dr Paul Griffin, Infectious Diseases Physician & Microbiologist, Nucleus Network
Cameron Johnson, CEO, Nucleus Network
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SOURCE Nucleus Network
