Health and life sciences

Spinogenix to conduct world-first clinical trial in Australia

US biotech company Spinogenix is conducting a world-first clinical trial in Australia. The company is investigating a therapy that could slow the progression of motor neurone disease.

Spinogenix is recruiting 112 participants for the trial, set to begin in 2024. It is seeking healthy volunteers and patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.

Nucleus Network will conduct the trials at its facilities in Melbourne, Victoria. The company is one of Australia’s largest Phase 1 clinical trials organisations. It has conducted over 1,000 trials for global biotechnology and pharmaceutical companies.

‘We are extremely pleased to receive approval from [Australia’s] Human Research Ethics Committee to proceed with human clinical trials,’ says Spinogenix Founder and CEO Dr. Stella Sarraf. ‘These human clinical trials will help us determine safety and tolerability in healthy volunteers. They will also provide early signals of efficacy of our novel, first-in-class drug to help improve the lives of people with ALS.

A new therapy to treat ALS

Founded in 2016, Spinogenix develops transformative therapeutics for diseases involving synaptic loss and dysfunction.

Spinogenix’s SPG302 treatment candidate is designed to increase the number of synapses in nerve cells. Synapses are the key connections between neurons that allow people to think, plan, remember and control motor functions. These faculties are diminished in neurodegenerative diseases like ALS.

In tests on mice, SPG302 was found to slow the progression of symptoms. It was also found to prolong life span by restoring broken neuron connections in the brain.

The current therapies for ALS provide only a modest extension of life and are not well tolerated by all patients. ALS is almost invariably fatal within 3 to 5 years of diagnosis.

A top destination for clinical trials

Australia has more than 50 clinical trial networks offering Phase I – IV clinical trials. Many clinical trial sites are in biomedical precincts close to universities, research institutions and private industry. Australia offers clinical trials for several biologics sub-sectors, including gene therapies, cell therapies, antibody-based therapies, CAR-T therapies and RNA therapies.

Data from clinical trials conducted in Australia is accepted by the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Australia’s streamlined regulatory approval system reduces the time it takes start clinical trials.

Australia also offers grants and incentives that can help reduce clinical trial costs.

Find out more about Australia’s clinical trials capabilities.

How Austrade helped

Austrade provided Spinogenix with information about Australia’s clinical trials ecosystem and facilitated introductions to local partners. Additionally, Spinogenix participated in Austrade’s Clinical Trials Roadshow in October 2022, which was delivered in partnership with IQVIA, 360 Biolabs, Bentleys and Nucleus Network.

Go further, faster with Austrade

• Contact Austrade for more information about investment opportunities in Australia
• Subscribe to the Investment Update newsletter to find out about new investment opportunities, insights and investor success stories across Australia. 

Published: 15 September 2023

Myeloid and NSW Government partner on A$96m manufacturing facility dedicated to RNA immunotherapies

Myeloid Therapeutics is building a state-of-the-art RNA manufacturing and research facility in Australia. The US company is partnering with the New South Wales Government and Macquarie University on the project.

The NSW Government is investing A$96 million in the facility. It will be the only site in Australia and one of a handful in the world where a wide range of RNA therapeutics and potential delivery technologies will be independently produced.

The facility will accelerate the commercialisation of Myeloid’s RNA-based therapeutics and enable the company to secure its supply chain for clinical development. The investment and collaboration will also enhance the growth potential of other biotechnology companies and researchers in Australia.

Speeding the development and commercialisation of RNA therapeutics

Myeloid is a clinical stage mRNA-immunotherapy company. It integrates the fields of RNA, immunology and medicine to develop novel therapies for cancer and autoimmune diseases.

The state-of-the-art RNA manufacturing and research facility will be at the Macquarie University campus in the Connect Macquarie Park Innovation District. The facility will include laboratories and other support spaces to support the development of products evaluated in Australian clinical trials and across the globe.

The facility will leverage NSW’s world-class cell and gene therapy expertise. It will also leverage the NSW RNA Production & Research Network, the UNSW RNA Institute and Australia’s first Viral Vector Manufacturing Facility at the Westmead Health and Innovation District.
   
Myeloid’s CEO and co-founder Dr. Daniel Getts is an Australian researcher.

‘By enabling control of our manufacturing processes, combined with our proven bioengineering capabilities and mRNA expertise, we have secured a unique, non-dilutive path to delivering our product portfolio to patients,’ he says.

‘We are proud to partner with NSW, who have demonstrated foresight and a willingness to innovate, by deploying capital for the facility and more broadly, for the health benefit of its citizens. We and NSW share the goal to bring innovative, cost-effective immunotherapies to patients who need them in a timely manner and on a consistent basis.’
   
Find out more about Australia’s thriving health and life sciences sector.

How Austrade helped

Austrade has supported Myeloid since May 2022. Austrade’s advice and introductions ensured Myeloid secured the best location and partners for its investment.

Austrade has:

• introduced Myeloid to Australian state governments to discuss opportunities

• invited Myeloid to various conferences and industry events where the company could meet Australian industry and build its network

• facilitated meetings with potential partners including medical research institutes and pharmaceutical companies

• arranged introductions to potential co-investors and financial sector leaders

• advised on Australian Government funding including the Medical Research Future Fund and Cooperative Research Centre grants

• invited Myeloid to join Austrade’s BIO23 delegation, where the company participated in panel discussions and attended Austrade’s investment roundtable.

Go further, faster with Austrade

• Contact Austrade for more information about investment opportunities in Australia

• Subscribe to the Investment Update newsletter to find out about new investment opportunities, insights and investor success stories across Australia.

Published: 3 September 2023

Singapore Success Story - Cerecin

Global pharmaceutical company Cerecin, which develops therapeutics for neurological disorders, is undertaking clinical trials and expanding its research capabilities in Melbourne, Australia. Charles Stacey, Cerecin’s President and CEO, explains why it has chosen Australia to expand its global footprint. Benefits include its diverse population mix, R&D incentives and human capital.

Read more about Australia's growing pharmaceutical industry.

Go further, faster with Austrade

Contact an Austrade Investment Specialist in your region for more information about the pharmaceutical industry in Australia.

Published: 13 April 2023

Singapore Success Story - Homage

Singapore’s Homage is bringing its personalised aged care and support services platform to the Australian market. Homage co-founder and CEO Gillian Tee explains why Australia is a strategic location for growth.

Read more about Australia's growing aged care industry.

Go further, faster with Austrade

Contact an Austrade Investment Specialist in your region for more information about aged care in Australia.

Published: 13 April 2023

Agility and innovation make Australia’s Linear a top clinical trials host

There was a time when Jayden Rogers had to explain to potential clients where Australia was and why they should conduct clinical trials here. Today, Australia is known as one of the best places in the world for clinical trials. This is in part due to the high-quality work undertaken by Rogers’ company, Linear Clinical Research.

Linear is an Australian not-for-profit organisation offering Phase I to Phase III clinical trials. To date, Linear has carried out over 420 studies in 20 therapeutic areas. It has worked with more than 300 sponsors from 18 countries. During the pandemic, the company saw record patient enrolments. It undertook over a dozen trials for COVID-19 therapeutics, two of which are now approved.

‘Australia has a well-deserved reputation as a world leader in clinical trials,’ says Rogers, Linear’s CEO. ‘We have a high-quality, advanced healthcare system, brilliant scientists and clinicians, and excellent R&D. Our streamlined regulatory approval process and generous research incentives also support international companies to conduct trials here.’

Tech innovation supports world-class trials

Founded in 2010, Linear has 2 state-of-the-art facilities in Western Australia. One of these is in the QEII Medical Centre, the largest medical precinct in the Southern Hemisphere.

Linear has a strong focus on Phase I healthy volunteer and Phase I cancer trials. The company has more than 100 early-phase cancer trials in its portfolio. It has one of the most active cancer trials team in the Asia-Pacific region.

Later in 2023, Linear will open a dedicated clinical trial private hospital for early-phase cancer trials. This will be the only one of its kind in Australia and it will triple Linear’s existing capacity.

Innovation has also played a part in Linear’s success. In 2017, the company was the first in Australia to install the eSource platform to capture data at the point of entry. It has also invested in telemetry and technology to monitor vital signs remotely. This investment in technology came to the fore during the pandemic.

‘Because we had electronic systems in place, we were able to switch to remote monitoring in just 7 days,’ says Rogers. ‘Our clinicians in Australia and clients in the US, Europe and China could view trial data in real time. It’s a collaborative way to run clinical trials.’

Clinical trials during COVID-19

Finding clinical trial participants during the pandemic was not an issue. In Western Australia, there is strong reach into many patient groups which are often consolidated into a small number of hospitals. This supports strong patient recruitment for clinical trials.

Linear also has over 40,000 healthy volunteer participants in its database. Australia’s multicultural population – 29% of citizens are born overseas – ensures a diverse patient cohort for clinical trials.

‘We delivered record enrolments for our cancer trials,’ says Rogers. ‘These patients would not have received treatment in other facilities. And we’re seeing amazing response rates. Up to 75% of patients observe some form of response with a small number experiencing complete responses (full remission) as a result of new therapeutics. It’s lifechanging.’

Linear also deployed its capabilities to support COVID-19 vaccine and therapeutic trials. The company worked with Chinese biotech Clover to undertake Phase I clinical trials for a vaccine candidate. It had the trial up and running in two weeks following ethics submission. The Phase I trial recruited 140 volunteers as a single site. This enabled a subsequent global Phase II/III trial that went on to demonstrate successful protection against COVID-19.

‘The Clover vaccine is now among the group of vaccines used in China,’ says Rogers. ‘It was thrilling to play a role in its development.’

Australia’s accelerated trial approval process

Linear undertook more than a dozen COVID-19 trials and prophylactic studies across a range of therapeutic modalities from 2020–2022. One of these was with Stanford University to trial an antibody to prevent COVID-19.

‘We worked around the clock with the Stanford researchers to help design the protocol,’ says Rogers. ‘Then we obtained ethics committee approval within 15 days, recruited patients and had the trial running within 20 days. It was the quickest clinical trial Linear has ever done. It is probably one of the quickest clinical trials in history, from the point of engagement to clinical execution and the delivery of data.’

Linear works with Bellberry, an organisation providing scientific and ethical review of human research projects. During the pandemic, Bellberry had an accelerated approval process for COVID-19 therapeutics and vaccines.

‘Australia’s pragmatic regulatory environment is one of our key strengths,’ says Rogers. ‘The Therapeutic Goods Administration delegates trial reviews to human-research ethics committees like Bellberry. This speeds approval times so clinical trials can be set up quickly but safely.’

Austrade paves entry into China

Almost all of Linear’s clients are international pharmaceutical or biotech firms. Most of them are from the US, followed by China and the EU. Rogers says Austrade was instrumental in helping Linear enter the Chinese market in 2017.

‘We’ve had tremendous support from Austrade over years,’ says Rogers. ‘The on-the-ground support in China was an important aspect of our growth in that market. Their staff went above and beyond. I would happily recommend Austrade to any business wanting to expand their overseas markets.’

Keeping innovation on the agenda

The past few years have seen major changes in therapeutics and approaches to clinical trials.

‘We’re seeing new molecules being tested, including bi-specific antibodies and drugs that target certain mutations based on genomics,’ say Rogers. ‘COVID-19 saw a shift to new treatments for infectious diseases and respiratory viruses. We’re seeing more targeted therapeutics, particularly mRNA therapeutics and cell therapies.

‘The world made a vaccine for COVID-19 in 12 months, thanks to research, industry and government working together,’ says Rogers. ‘At Linear, we want to keep pushing the innovation agenda. It’s the only way we can keep creating drugs that save lives.’

Read more about why Australia is a go-to destination for clinical trials.

Go further, faster with Austrade

Contact an Austrade Investment Specialist in your region for more information about conducting clinical trials in Australia.

Published: 30 March 2023

Australian bovine tissue keeps hearts beating worldwide

Since 2015, tens of thousands of Australians have benefited from Edwards Lifesciences’ transcatheter aortic heart valve device. These lifechanging devices are made from Australian bovine tissue. Australian cows – raised in clean, green environments and famed for their health – provide the high-quality tissue needed to produce these devices. 

‘We have sourced bovine tissue from Australia for almost 20 years,’ says Polo Guilbert-Wright, Government Affairs Senior Director at Edwards Lifesciences Australia. ‘We look for tissue that is consistently healthy, and our Australian suppliers always deliver. We also have full traceability across the supply chain.’ 

Sourcing lifesaving bovine tissue from Australia  

Edwards Lifesciences designs, develops and manufactures products for structural heart disease and critical care monitoring. The California-based company set up a subsidiary in Australia in 2001 and now employs over 100 people across 5 states.  

A critical component of Edwards Lifesciences’ heart valves is bovine pericardium tissue (the sac that surrounds a cow’s heart). This thin but durable tissue is a key part of the transcatheter aortic valve implantation (TAVI) used to treat aortic stenosis. 

Edwards Lifesciences sources this tissue from multiple suppliers in the US and Australia. Australia provides more than half of the company’s tissue supply. It sources tissue from multiple suppliers in Queensland. Guilbert-Wright says Australian bovine tissue is outstanding. 

‘We need to make sure the thickness and performance of the “leaflets” (the thin flaps of tissue used to make heart valves) are consistent,’ he explains. ‘Otherwise, they will affect how blood flows through the heart. We find the tissue coming out of Australia is consistent and of a high quality.’ 

Fully traceable from paddock to patient 

Edwards Lifesciences’ Australian suppliers extract, clean and pack the tissue into Eskies filled with wet ice. These Eskies are transported to the US and Singapore where the tissue is manufactured into heart valves. This process must be completed in 96 hours. 

‘Our Australian suppliers document the entire process,’ says Guilbert-Wright. ‘We can trace the tissue back to a group or lot of cattle and follow it until it arrives. It ensures full accountability across the supply chain.’ 

IFAM flies lifesaving tissue to the US 

The closure of international borders due to COVID-19 threatened to cut off a critical supply chain. Overnight, there was no way to transport the tissue from Australia to the US. 

Edwards Lifesciences immediately turned to Austrade for help. Within a short period of time, the agency obtained the permissions that enabled the company to access the International Freight Assistance Mechanism (IFAM). IFAM was a temporary, targeted, emergency support measure put in place by the previous Australian Government. It kept global air links open in response to the effects of the pandemic. 

Edwards Lifesciences used IFAM to airfreight bovine tissue from April 2020 until June 2022. The service ensured the tissue reached the California production facility before its 96-hour expiry period. The company imported more than 400,000 batches of tissue over that time. 

‘The IFAM flights helped keep the supply chain of our tissue between Australia and the US open,’ says Edwards Lifesciences Managing Director for ANZ, Pat Williams. 

‘We have been able to continue sending bovine tissue from Brisbane to Irvine, where they are manufactured into life-saving heart valves and sent to patients all over the world.’ 

Austrade has supported Edwards Lifesciences for several years. In addition to IFAM, the agency has provided information on Australia’s regulatory environment and its clinical trials infrastructure. It has also introduced the company to various arms of government. 

Trialling next-generation products in Australia 

Edwards Lifesciences also undertakes clinical trials in Australia. The company works with a number of Australian hospitals that contribute to global clinical trials. It also works with tertiary hospitals that recruit and treat patients. 

Guilbert-Wright says there are many reasons why Australia is a great place for clinical trials. 

‘The quality of clinical outcomes is outstanding,’ he says. ‘The infrastructure – in terms of the hospitals and their ability to recruit and treat patients – is impressive.  

‘The Australian clinical fraternity is first-rate. The clinicians we partner with are on the podium at all the global cardiac symposia. We are privileged to partner with them. 

‘It’s also easy to set up clinical trials here,’ he adds. ‘That’s a real comparative advantage for Australia as compared to other jurisdictions.’ 

Australia also has a globally recognised regulatory system. Data from clinical trials conducted in Australia is accepted by overseas regulatory agencies. 

Find out why Australia is a go-to destination for clinical trials. 

Go further, faster with Austrade 

Contact Austrade for more information about investing in Australia’s health and life sciences industry. 

Published: 14 March 2023