Melbourne, Australia, Friday, 11th September. Australia’s largest Phase 1 clinical trials specialist, Nucleus Network, has this week started the first human trials of a potential COVID-19 treatment developed by Singlomics (Beijing DanXu) Biopharmaceuticals and licensed by BeiGene, Ltd.
Twenty-four healthy participants, aged 18 to 59 years of age, have been screened to take part this Phase 1 randomised, double-blind placebo-controlled trial BGB-DXP593 under the guidance of Nucleus Network’s leading expert in infectious disease, principal investigator Assoc. Professor Paul Griffin.
Nucleus Network has generated significant specialty experience in the COVID-19 clinical trial sector, with three COVID-19 vaccine candidate trials. Nucleus Network CEO Cameron Johnson identified this trial as one of great significance to the current situation.
“We are proud of our work with clients to help their development of a COVID-19 vaccine, but we also understand that an effective and safe treatment of COVID-19 forms an integral part of a medical response to this virus,” he said. “Nucleus Network is honoured to be part of the team helping BeiGene and other world-leading biopharma companies that can help them bring safe and effective treatments to a global market.”
BeiGene was founded in 2010 and started its first clinical trial in Australia in 2013. BeiGene currently is conducting many trials in Australia and has an Australian team based in Sydney.
Regarding the investigational treatment being tested, Sunney Xie, Lee Shau-Kee Chair Professor of Peking University, Director of Beijing Advanced Innovation Center for Genomics (ICG), and Co-Founder and Chairman of the Scientific Advisory Board at Singlomics, was looking to provide a more effective solution than some of the first generation plasma treatments being used on patients.
“Our goal was to find highly potent neutralizing antibodies as quickly as possible in order to develop a potential treatment that can be scaled to treat more patients than convalescent plasma therapy can provide,” said Dr. Xie.
The treatment known as DXP-593 is based on leveraging the antibodies identified in people who have recovered from SARS-CoV-2, the virus that causes COVID-19.
“Dr. Xie has made an important contribution to our understanding of COVID-19, utilizing single cell genomics to find potentially human neutralizing antibodies,” said Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development, at BeiGene. “We are looking forward to this clinical trial and to contributing to the worldwide effort to develop novel treatments for patients with COVID-19.”
“We have selected Nucleus Network to conduct this trial due to their reputation, experience, and ability to coordinate with our global network of medical researchers,” he added.
The clinical trial will be led by Nucleus Network Principal Investigator Assoc. Professor Paul Griffin. “COVID-19 is undoubtedly the biggest challenge in the medical research field right now,” he said. “By working with BeiGene to help them to develop a treatment, we hope to find a holistic and long-term solution to the current pandemic.”
“We are also encouraged by the number of people volunteering to join the clinical trials we conduct. With the global focus on finding a way through this pandemic, the efforts of medical researchers around the world, and the contributions of everyday Australians, we are hopeful that we will see viable options for the treatment and prevention of COVID-19.”
DXP-593 is a SARS-CoV-2 neutralizing antibody drug candidate identified by high-throughput single-cell RNA and VDJ sequencing of antigen-enriched B cells from over 60 convalescent patients. DXP-593 has exhibited strong neutralization potency in preclinical testing, with an IC50 of 1.2 ng/mL and 15 ng/mL against pseudotyped and authentic SARS-CoV-2, respectively. It displayed strong therapeutic and prophylactic efficacy in SARS-CoV-2-infected rodent models. DXP-593 can potentially be used as a cocktail treatment option that could avoid resistance due to viral mutation.
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.
Nucleus launched in 2003 from a $1million Victorian Government Science and Technology Innovation grant and we are now an international company with clinics in Melbourne, Brisbane and Minneapolis, playing a major role in the race for a COVID-19 vaccine and as well as vital COVID-19 treatments.
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