Human trials begin for potential world-first rheumatoid arthritis treatment

Human trials of an innovative treatment for rheumatoid arthritis developed by The University of Queensland have begun in Brisbane.

DEN-181, a vaccine-style treatment referred to as an ’immunotherapy’, targets the underlying cause of the disease rather than treating its inflammatory symptoms.

Patient trials at a clinical research facility at the Princess Alexandra Hospital began last week.

UQ’s Diamantina Institute research team, led by Professor Ranjeny Thomas, discovered the body’s immune system could be ‘re-educated’ to turn off, rather than react to a self-antigen responsible for autoimmune disease like rheumatoid arthritis. This led to the development of DEN-181.

DEN-181 is being commercialised by Dendright Pty Ltd, a start-up company of UniQuest, UQ’s commercialisation company.

UniQuest CEO Dr Dean Moss said the first-in-human trial was a momentous step towards making the breakthrough research discovery a treatment reality.

“This is an important milestone in developing a new medicine for the millions of people affected by this debilitating disease which destroys joints, causes cardiovascular complications and can reduce life-span,” he said.

Professor Thomas, who is also Dendright’s Chief Scientific Officer, said the phase 1b clinical trial was the bridge to bringing scientific data into clinical practice.

“The study team will be monitoring and assessing DEN-181 safety and immunological response in patients and we thank the participating patients and referring rheumatologists,” she said.

UQ Advancement Director of Development and Philanthropy Andrew Pentland said Arthritis Queensland had been an important supporter of UQ’s translational research and approaches to understanding disease biology since the early 1990s.

“Arthritis Queensland has provided philanthropic funding for the Arthritis Queensland Chair of Rheumatology at UQ over many years,” he said.

“This is a great example of how a philanthropic partnership can help drive important research outcomes for the benefit of community.”

Professor Thomas is the inaugural recipient of the Arthritis Queensland Chair of Rheumatology at UQ.

Dendright entered into a research collaboration and option to license agreement with US-based Janssen Biotech, Inc. (Janssen) in 2013.

This year Janssen agreed to provide additional funding to support further research, including the first-in-human safety trial and tolerability study that began in Brisbane last week.

Funding for the clinical program is also being provided by not-for-profit organisation Arthritis Queensland.

Enquiries regarding study criteria can also be directed to joanne.tesiram@health.qld.gov.au.

About DEN-181

DEN-181 is a nanoparticle-based immunotherapy designed to regulate activated immune cells which cause inflammation, pain and joint damage in rheumatoid arthritis.  Laboratory studies have shown that activated immune cells can be regulated in an antigen-specific manner through nanoparticle delivered signals. DEN-181 has the potential to offer higher specificity of effect and lower toxicity than current treatments for RA given the lack of broadly suppressive effects on the immune system. DEN-181 was discovered and developed by researchers at the University of Queensland and commercialised by the UniQuest start-up company, Dendright Pty Ltd.

About Dendright Pty Limited

Dendright Pty Ltd was established by UniQuest in 2005 to enable Professor Ranjeny Thomas and her team to find a treatment for Rheumatoid Arthritis by focusing on ways that the body’s own immune system could “re-educate” the cells that cause tissue damage associated with rheumatoid arthritis. In 2012, the company received a seed grant from Janssen-Cilag Pty Ltd in Australia, one of the Janssen pharmaceutical companies. Before 2012, the company had been assisted by grants from the Queensland Government’s Innovation Start-up Scheme and the Australian Government’s Biotechnology Innovation Fund. In 2013, Dendright entered into a R&D Collaboration and Option to License Agreement with Janssen Biotech, Inc. and subsequently received Experienced Executive grant funding from Australian Government’s Commercialisation Australia program. In 2017, Janssen extended its collaboration with Dendright and Arthritis Queensland agreed to also contribute funding to the clinical program. Dendright’s core technology patent, which describes the particulate co-delivery of target antigens and NF-kB inhibitors to immune cells, was granted by the United States Patent and Trademark Office (USPTO) as US Patent Application 12/444,790 in 2015. Dendright has also secured the grant of related patents in Australia, Canada and China.

About Arthritis Queensland

Arthritis Queensland is a not-for-profit organisation, providing education, information, and support services for Queensland children and adults living with arthritis. Arthritis Queensland also provides financial support for research into treatments, and ultimately a cure for the more than 100 forms of arthritis.

About UniQuest Pty Limited

UniQuest is Australia’s leading university commercialising entity, managing the intellectual property of The University of Queensland. It benchmarks in the top 10 percent globally for university-based technology transfer offices. As a result, UQ generates more licence income and holds greater equity in its start-ups than the other Group of Eight universities combined.