Leading cell manufacturing facility, Q-Gen Cell Therapeutics, has its sights set on Asia and America as its international reputation continues to grow beyond Australia.
Q-Gen is the cellular therapy manufacturing facility of QIMR Berghofer Medical Research Institute. For almost 25 years, it has been supporting research projects and working with world-leading clients in treating cancer, infectious diseases and autoimmune disorders.
QIMR Berghofer is one of Australia’s most successful medical research institutes, translating impactful discoveries from bench to bedside for better health and wellbeing. Director and CEO Professor Fabienne Mackay is committed to taking the Institute to the next level with next-generation biomedical innovation and manufacturing. Q-Gen is at the heart of this.
Advancing cell therapy expertise to change patients’ lives
Under the stewardship of Professor Rajiv Khanna and support from the Q-Gen team, the centre runs world-leading cell therapy programs to progress the research and clinical trials being run by QIMR Berghofer. It also collaborates with commercial partners from around the world to advance cell therapy research and treatments.
The facility provides potentially life-saving cell therapies to critically ill patients as an authorised provider under the TGA’s special access scheme, offering last-resort treatments for serious diseases.
Q-Gen’s trajectory has advanced markedly since 2015 when QIMR Berghofer secured a TGA licence to manufacture autologous T-cell therapies, initiating Phase II clinical trials in Australia and Hong Kong.
A year later, QIMR Berghofer licensed IP created by distinguished scientist Professor Khanna to Atara Biotherapeutics in the US.
‘Professor Khanna has a particular talent for translating discoveries into clinical practice,’ says QIMR Berghofer Director and CEO Professor Fabienne Mackay. ‘He, his team and the world-class Q-Gen facility really epitomise QIMR Berghofer’s commitment to delivering transformative research outcomes that improve patient health and wellbeing.’
Atara initially engaged Professor Khanna and his team to manufacture his cell therapy for Phase I clinical trials in Australia and the US. This has now advanced to Phase II trials in Canada, Australia and the US. Phase III trials are expected to occur in the next year or two.
Delivering results internationally
Professor Khanna received an Order of Australia in 2017 for distinguished service to medicine in the field of immunology, through contributions to the development of cellular immunotherapies. When it comes to clinical translation and industry partnerships, Q-Gen is a leader in delivering results. The facility houses 13 clean rooms spread across 2,600 sqm. It employs a team of around 40 people in Australia.
Q-Gen supports research institutes across the country to develop medicines and advance clinical trials. International clients include Atara Biotherapeutics, Arovella Therapeutics. Hudson Institute, Cellevolve, Alloplex Biotherapeutics, Nkarta and Prescient Therapies.
Q-Gen is currently working with Alloplex Biotherapeutics on developing a cellular therapy to treat cancer where activated cells target tumours with no harm inflicted on normal tissue.
Alloplex CEO and Founder, Frank Borriello, says the company partnered with Q-Gen for its expertise, its ability to manufacture cells according to GMP (good manufacturing practice) conditions, and its regulatory approval status.
‘Working with them, we’ve been able to take the asset from the pre-clinical stage to now having treated over 25 patients and the results are spectacular,’ says Borriello.
A top destination for clinical trials
Australia is a first-choice destination for therapeutics companies looking to conduct clinical trials.
‘Q-Gen is probably one of the only facilities in Australia, which has supplied cell therapies in Asia and North America for clinical trial use,’ says Professor Khanna.
‘Q-Gen has complete start-to-end capabilities to deliver cell therapies, particularly T-cell therapies for clinical trials, starting from Phase I and beyond.’
Professor Mackay says the financial incentives in Australia also attracted international investment here.
‘The Australian Government supports the sector by putting in a research and development tax incentive in the order of 40–45%,’ she says. ‘That makes it very attractive for companies to engage an advanced biotechnology facility like Q-Gen.’
Dr Mathias Kroll, Chief Commercial Officer at QIMR Berghofer, is confident that Australia will continue to build its reputation as a world leader in cell therapy and clinical trials as the frontiers of cellular therapies continue to push forward. He foresees a future when Q-Gen is positioned as a regional leader and training institute for cell research throughout Southeast Asia.
Dr Kroll’s presentation at BIO2023 will focus on the importance of decentralising and establishing regional champions in medical science in the interests of patients, innovation and the development of local ecosystems.
‘Australia has a world-class system and in certain settings, competition for patients could be lower, and the speed of recruitment higher, than in the US or in other geographic regions,’ he says.
He also points out that unit cost in clinical development is 20–50% less than in the US. It is also easy for international commercial partners to conduct trials in Australia while maintaining high-quality standards.
‘Additionally, Australian data is recognised in principle by the FDA. So, if you execute your clinical trial strategy correctly and communicate [with the FDA], you can actually seamlessly follow on with pivotal clinical trials in the most commercially attractive regions, like the US, if you do early-stage clinical development in Australia.’
Expectations for growth in the Asia-Pacific region
Q-Gen is expanding its partnerships in Southeast Asia, particularly in Hong Kong and India where it has been working with Austrade to promote the Brisbane-based facility.
In line with a fast-expanding global cell therapy market, Asia Pacific is leading the world in growth rates and is fast catching up to the US. Considering the size and trajectory of the Asia Pacific region in cell therapy development, most of its potential is still to be realised, according to Professor Khanna.
QIMR Berghofer has been working with Austrade in Bangalore and Mumbai as well as research centres in those regions. In Hong Kong, it has a long-standing collaboration with the University of Hong Kong, Queen Mary Hospital. Local philanthropic agencies have funded QIMR Berghofer clinical cell therapy programs for head and neck cancer in the past.
Professor Mackay says one of the big requirements is attracting good people into the working field of advanced bio. She predicts that over the next 10 to 20 years, Australia will need hundreds, if not thousands, of recruits into an industry that has changed many things, but most notably, the way in which cancers are treated.
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