Nucleus Network – Australia’s largest phase-1 clinical trials specialist – has been tasked by biotechnology company Novavax to begin Phase 1 clinical trials. 

The clinical trials which are set to begin in the second-half of May, will be the first time a COVID-19 drug has been trialed in humans outside of the United States.

“Any medication you have ever taken, whether it be an antibiotic, pain medication, etcetera. Somebody, somewhere in the world had to be the first person to take that drug. And that’s where Nucleus Network comes in.” says Nucleus Network’s CEO, Cameron Johnson.

Administering the trials across 150 beds in Melbourne and Brisbane, it is hoped there will be a drug available to the public within 9 to 12 months. 

Working together

By the time it was awarded the contract to trial NVX-CoV2373, Nucleus Network had already established an extensive and successful relationship with Novavax, developing their Ebola vaccine in 2015, along with other drugs.

But it wasn’t just the expertise and the knowledge Nucleus Network holds which appealed to Novavax, time is a factor. With every passing day without a vaccine, countless lives are at risk. Time is not a luxury we can enjoy during this crisis.

According to Nucleus Network’s Chief Medical Officer (CMO) Dr Jason Lickliter, “Australia is well-known internationally for its high quality of work… but it’s also known as having one of the fastest jurisdictions in the world to have a clinical trial approved, then up and running.”

Though the theory of the proposed vaccine is proven, there are no guarantees of efficacy. 

“If something is not going to work, you want it to fail early on so you can move on to the next thing that has a better chance of working” says Dr Lickliter. 

Finding a cure

Though a disease like COVID-19 hasn’t impacted the world to this extent for over 100 years, the development of drugs to combat the disease is the same for any common virus. 

There are two strategies in which a cure can be found for COVID-19. The first is through therapeutics which are designed to treat the disease itself or to counteract its symptoms. These therapeutic drugs are designed to reduce the severity of the disease once it arises. 

The second strategy is a prevention such as a vaccine. Rather than fighting the symptoms, these drugs are designed to prime the person’s immune system, preparing it to be able to recognise and eliminate the threat before it takes hold. 

The drug which Nucleus Network is trialling is the latter.

The way most common preventative vaccines work is by introducing a small amount of an inactivated disease-causing microorganism (or parts thereof) to trigger an immune response and be ‘remembered’ as a threat. In the event the disease is ever be reintroduced, the immune system will know to fight it.

Injecting willing volunteers with COVID-19 is obviously a bad idea and unsafe. Remembering back to high school biology, viruses are made of smaller proteins. The participants are injected with a purified protein of the coronavirus which sits on the surface of the virus. 

“There’s actually no virus particles in the vaccine, so there’s nothing that can proliferate or turn into an active viral infection” says Dr Lickliter.

Theoretically, by the person’s immune system recognising the protein which makes up part of COVID-19, the immune system will recognise, respond and eliminate the virus before the infection becomes severe. 

COVID-19

COVID-19 has already proven itself to be one of the greatest challenges to society in history, not just as a disruption to business and social normalities, but as a riddle for the scientific community to solve. 

“What makes COVID-19 such a bad disease is that it’s very contagious and it’s relatively virulent, not as virulent as SARS, which is another coronavirus disease that had a higher death rate, but SARS did not spread as readily as COVID-19.”

As the virus remains a conundrum for scientists, and without a cure to date, isolation and avoidance are the only weapons we have to fight the disease. 

“Most communities don’t have any history with COVID-19 and no significant immunity. If we leave things to business as usual, it will spread like wildfire. The only way to prevent it from spreading, is to lock the community down or markedly increase social distancing to prevent the spread.”

Despite the flattening of the curve in Australia and many other countries around the world, the chances of a resurgence are still very possible, and not a risk society should take. 

“Unless social distancing has a much greater impact and totally gets rid of the virus much faster than we thought, then there is going to be a huge unmet social and medical need to find a vaccine.

What is a phase-1 trial?

A phase-1 clinical trial, which Nucleus Network is conducting, is designed to test a new intervention against a disease in a group of people to evaluate the safety of the proposed drug.

Dr Lickliter compares a phase-1 clinical trial to road-safety tests.

“Like testing cars at ANCAP, you get a car and you crash it in a certain way and you see what happens to the car. The same is true with a vaccine trial: the company has made the drug the best it can and tested it on animals, and you’re confident that it’s safe, you know it produces an immune response in the animals, now it’s ready for human testing.”

During the phase-1 trial, the drug is introduced to people gradually to limit the adverse reactions if there are any. Different doses of the vaccine are tested and adjuvants may be added to increase the immune system’s response. Placebos may also be used as a control between participants.

“Throughout all of this you take blood tests over time to evaluate for the development of antibodies against the virus and cellular-immune responses.”

This process takes time and requires meticulous precision in order to determine an outcome and appropriate doses going forward. 

Opportunity in tragedy

It is not by chance that Australia has become the home of the first phase-1 clinical trial outside of the United States for COVID-19. Though the COVID-19 pandemic has been a tragic and horrendous event for the world, Australia’s wider biotechnology and medical industries are positioned to make tremendous gains.

CEO Cameron Johnson says Nucleus Network has already witnessed a bolstering of confidence in the company and the Australian industry from overseas. 

“Since Australia’s flattening of the curve and the rising cases in Europe and America, we have definitely seen an increase in clients looking to Australia as a potential rescue for them as clinical trials  in America or Europe aren’t being conducted  due to the Government shutdowns.” 

It is also important to remember that even though COVID-19 poses a serious threat to people, there are other diseases which pose a major health risk to people around the world. 

“The media spotlight on COVID-19 has really put forward the importance of drug development. Nucleus Network knows the COVID-19 pandemic has been a horrible situation, but there are a lot of other terrible conditions out there that also need development”, says Johnson.

Though Australia is positioned for success, Dr Lickliter reminds us that despite the flattening of the curve and our relatively low infection rates, now is not the time for complacency. 

“As we’ve seen in other parts of the world, there are definitely risks of second waves… It would certainly harm [Australian] businesses if social distancing rules were to be relaxed and we were to experience a second wave, also harder on [Nucleus Network] to do further studies.”