qimr medical research institute

QIMR Berghofer Medical Research Institute

Established in 1945 by the Queensland Government, the QIMR Berghofer Medical Research Institute (formerly the Queensland Institute of Medical Research) is a world leading translational research institute focused on cancer, infectious diseases, mental health and a range of complex diseases. Working in close collaboration with clinicians and other research institutes, our aim is to improve health by developing new diagnostics, better treatments and prevention strategies.

QIMR Berghofer is home to more than 700 scientists, students and support staff in six research departments (in over 50 separate laboratories) and a support division.

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Summer’s over, so how much sun can (and should) I get?

Katie Lee , The University of Queensland and Rachel Neale , QIMR Berghofer Medical Research Institute

Our mood usually lifts in spring. But after early heatwaves and bushfires, this year may be different

Tara Crandon , QIMR Berghofer Medical Research Institute

Emotional abuse is a pattern of hurtful messages – building parenting skills could help prevent it

Divna Haslam , Queensland University of Technology ; Alina Morawska , The University of Queensland , and James Graham Scott , QIMR Berghofer Medical Research Institute

Is ‘climate anxiety’ a clinical diagnosis? Should it be?

Fiona Charlson , The University of Queensland and Tara Crandon , QIMR Berghofer Medical Research Institute

I’m at home with COVID. When do I need to see a doctor? And what treatments are available?

Tari Turner , Monash University ; Bridget Barber , QIMR Berghofer Medical Research Institute ; Josh Davis , University of Newcastle , and Steven McGloughlin , The National Trauma Research Institute

‘Got no friends? Sit on the buddy bench.’ Untested anti-bullying programs may be missing the mark

Karyn Healy , QIMR Berghofer Medical Research Institute

There’s no single gene for left-handedness . At least 41 regions of DNA are involved

David Evans , The University of Queensland and Sarah Medland , QIMR Berghofer Medical Research Institute

You’re not the only one feeling helpless. Eco-anxiety can reach far beyond bushfire communities

Fiona Charlson , The University of Queensland and James Graham Scott , QIMR Berghofer Medical Research Institute

Is social media damaging to children and teens? We asked five experts

Alexandra Hansen , The Conversation

Why do many people with Parkinson’s disease develop an addiction? We built a virtual casino to find out

Philip Mosley , QIMR Berghofer Medical Research Institute

For people with a mental illness, loved ones who care are as important as formal supports

Emily Hielscher , The University of Queensland ; James Graham Scott , QIMR Berghofer Medical Research Institute , and Sandra Diminic , The University of Queensland

It’s perfectly legal for doctors to charge huge amounts for surgery, but should it be allowed?

Louisa Collins , QIMR Berghofer Medical Research Institute

Origines de l’asthme : ce que l’on sait, ce que l’on suspecte

Simon Phipps , QIMR Berghofer Medical Research Institute and Md. Al Amin Sikder , The University of Queensland

What causes asthma? What we know, don’t know and suspect

Why does Australia have so much skin cancer? (Hint: it’s not because of an ozone hole)

Terry Slevin , Cancer Council Australia and David Whiteman , QIMR Berghofer Medical Research Institute

New online tool can predict your melanoma risk

Phoebe Roth, The Conversation

Research Check: do most melanoma patients have fewer than 20 moles?

H. Peter Soyer , The University of Queensland and Richard Sturm , The University of Queensland

Interactive body map: what really gives you cancer?

Emil Jeyaratnam, The Conversation and Sasha Petrova, The Conversation

Nobel Prize in Chemistry highlights how our bodies can repair our fragile DNA

Kum Kum Khanna , Queensland Institute of Medical Research ; Amanda L Bain , QIMR Berghofer Medical Research Institute , and Janelle L Harris , QIMR Berghofer Medical Research Institute

Common painkillers could decrease skin cancer risk

Reema Rattan, The Conversation and Nicki Russell, The Conversation

Associate Professor, infectious diseases, QIMR Berghofer Medical Research Institute

Senior Research Officer, QIMR Berghofer Medical Research Institute

Professor and Group Leader at the Cancer Control Group, QIMR Berghofer Medical Research Institute

Team Head, Cardiovascular Disease Prevention, QIMR Berghofer Medical Research Institute

Honorary Professor and Consultant Psychiatrist, QIMR Berghofer Medical Research Institute

Research scientist, QIMR Berghofer Medical Research Institute

Professor - Health Economics, QIMR Berghofer Medical Research Institute

Group Leader, Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute

Research Fellow, Systems Neuroscience Laboratory, QIMR Berghofer Medical Research Institute

Principal research fellow, QIMR Berghofer Medical Research Institute

Cordinator Mental Health Research Program, QIMR Berghofer Medical Research Institute

Associate Professor, Respiratory Immunology, QIMR Berghofer Medical Research Institute

Psychologist and PhD Candidate, QIMR Berghofer Medical Research Institute

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QIMR Berghofer Medical Research Institute (QIMR)

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The Queensland Institute of Medical Research was established in 1945 to research tropical and infectious diseases found in northern Australia. Today, QIMR Berghofer is one of Australia’s largest medical research institutes, renowned for its world-leading efforts in both discovery research and translational research. The Institute’s research is focused on cancer, infectious diseases, mental health, and chronic disorders. The Institute includes 55 laboratories across four separate departments: Cell and molecular biology, genetics and computational biology, immunology, and population health. Working in close collaboration with clinicians, hospitals, universities and research institutes in Australian and around the world, the Institute’s aim is to improve human health by developing new and better prevention strategies, diagnostics and treatments.

• Queensland statutory authority

Strengths and capabilities

• Cancer research
• Mental health
• Infectious diseases
• Chronic disorders
• Clinical trials
• Cellular therapeutics

Facilities and major equipment

• Good Manufacturing Practice (GMP) facility for cellular therapeutics
• Two quarantine-approved PC2 and PC3 insectaries
• ACRF Centre for Comprehensive Biomedical Imaging
• Physical Containment Class 2 (PC2) laboratories
• Physical Containment Class 3 (PC3) laboratories
• Clinical trials facility

Achievements of the centre

• Discovery of Ross River virus, surveillance techniques for monitoring mosquitoes, and clinical trials for malaria vaccines
• Clinical trials for immunotherapy treatments of brain cancer; skin cancer prevention, detection
• Developing a diagnostic test for depression

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More information about the sectors this centre is involved in:

• Biotechnology
• Engineering
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• Health and medical

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April 12, 2024

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Inflammation discovery advances the fight against chronic liver disease

by QIMR Berghofer Medical Research Institute

In a world-first, QIMR Berghofer scientists have discovered the mechanism that causes severe inflammation among millions of people with chronic liver disease.

Published in Science Signaling , the discovery identifies how and why elevated ferritin (a protein that normally stores iron within cells) causes inflammation which ultimately leads to liver dysfunction including cirrhosis, liver cancer , and liver failure if left untreated.

Professor Grant Ramm, Deputy Director of QIMR Berghofer Medical Research Institute and head of the Hepatic Fibrosis Laboratory, said this finding could pave the way for new targeted therapeutics to treat both inherited and acquired liver disease.

"The association between inflammation and circulating ferritin levels in chronic liver disease is well known. However, rather than simply acting as a passive marker of inflammation, our research has demonstrated that tissue-derived ferritin stimulates a cascade of events at a cellular level, accelerating liver inflammation," said Professor Ramm.

"Inflammation is integral in driving early liver scarring, known as fibrosis. If undiagnosed or untreated, scarring can increase over time, severely impacting liver function.

"This study showed that ferritin binds to receptors on a particular type of liver fibroblast called hepatic stellate cells which causes the release of specific and potent cytokines. This process triggers inflammation, which in turn contributes to fibrosis and the progressive loss of liver function."

Professor Ramm said now that we understand the mechanisms responsible for this type of inflammation, we can conduct investigations aimed at interfering with the interaction between ferritin and its receptor to disrupt this liver inflammation .

"Advancing our understanding of the cell biology and mechanisms of inflammation is an important first "discovery research" step in the search for potential therapeutic targets which could alleviate inflammation and transform the lives of millions of people globally who suffer from liver disease," he said.

"Looking ahead our aim is to develop new anti-inflammatory therapeutics to treat inflammation and fibrosis and prevent the progression of chronic liver disease .

"We are currently using state-of-the-art molecular modeling techniques to identify the ferritin binding sequences on cell surface receptors that signal these proinflammatory cytokines."

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QIMR Berghofer Medical Research institute

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QIMR Berghofer's dementia laboratory is on the cusp of a breakthrough in treatment

By Alicia Nally

ABC Radio Brisbane

Topic: Medical Research

QIMR Berghofer Medical Research Institute Associate Professor Tony White and PhD student Joanna Wasielewska are part of a team researching cellular processes in neurodegenerative diseases. ( ABC News: Alicia Nally )

In a towering, modern building overlooking the Brisbane showgrounds, scientists are so close to a breakthrough in dementia treatments, the optimism is almost palpable.

Under the direction of cellular and molecular neurodegeneration laboratory group leader Associate Professor Tony White, researchers are quietly studying how brain cells react to different treatments at Herston's QIMR Berghofer Medical Research Institute.

While science still doesn't understand the causes of dementia, experts do know that for existing drugs to be effective they need to penetrate the barrier between the blood and the brain.

And that is proving to be the most difficult aspect of dementia research.

"The brain has a barrier between the blood and the brain to stop anything the brain doesn't want to get in there such as bacteria or toxins, but it also means that drugs can't get into the brain," Dr White says.

"About 98 per cent of all drugs delivered to the brain don't get in there.

"So, we're trying to find ways to open that barrier up and allow the drugs to get in and that's something we're very focused on here.

"There are a lot of people working on different drugs to treat Alzheimer's and dementia but most of those drugs won't get into the brain.

"If we can find a way to open the blood-brain barrier to let drugs go from blood into the brain that will be a major advance in treating Alzheimer's and dementia."

What is dementia?

In a healthy brain, two proteins — amyloid and tau — happily share the space.

But in Alzheimer's sufferers, the compounds combine and start to form plaques on the brain tissue that kill healthy brain cells.

Dr White says these changes in how the proteins interact happen "very early" in life but there is still no way to detect them.

"But by the time you're in your 60s and 70s, we start to see a build-up of amyloid in the brain and tau accumulates inside neurons and these cause the degeneration of brain cells and the inflammation of other cells in the brain.

"It's not something that happens rapidly, it takes decades to occur."

Dr White's team is inching closer to providing a more hopeful future for the roughly 500,000 people living with dementia in Australia.

Ms Wasielewska's work with ultrasound is helping open the blood-brain barrier and get more drugs to where they are needed. ( ABC News: Alicia Nally )

He was instrumental in discovering a copper-based drug which removed some of the amyloid plaque that forms on the brain.

That achievement led to a drug which is still in clinical trials.

Dr White's current work with PhD student Joanna Wasielewska is also having success in using ultrasound to get more beneficial drugs into the brain to treat the condition.

Tiny model brains up to 8mm in diameter are grown from the tissue of dementia sufferers to be used in trials. ( ABC News: Alicia Nally )

While usually a condition that affects adults, there are about 70 diseases which also cause childhood dementia, a devastating diagnosis the QIMR Berghofer team is also focusing on finding answers for.

Tiny organs changing research

In a small room off the main lab sits a fairly innocuous-looking storage unit.

From the outside, it could be confused with a tiny bar fridge but on the inside are small, spinning discs that contain tiny brains.

Grown from the tissue of dementia sufferers, the largest brains measure just 8mm and take up to two months to grow.

It is these small organs that researchers use to test new ways of breaching the blood-brain barrier.

Dr Romal Stewart is in charge of the tiny specimens, which he says need daily attention for the first few weeks of their life.

Dr Stewart spends months monitoring the growth of the brains closely. ( ABC News: Alicia Nally )

"For the first two weeks or so, you need to do daily media changes," he says.

"Scientists would be the only people fighting institutions not to take holidays because sometimes we need to be here all the time.

"During the start of the pandemic, it was difficult and we were writing letters asking if we could keep coming in to the lab."

Such important research was allowed to continue despite COVID restrictions.

Personal mission for researcher

Dr White began his career in dementia research 30 years ago and just a decade in, tragedy struck when his mother Patricia was diagnosed with the disease in her 70s.

"I worked in the field and understood what was going on. There were no drugs I could suggest that were going to improve her outcome," he said.

"My father, who was looking after my mother at the time would quite often ask about the latest treatment and whether there was anything on the horizon.

Dr White says treatments to slow dementia onset are possible in the near future. ( ABC News: Alicia Nally )

"But there was nothing that was going to be able to help her at the time. 

"It really helped me to focus on trying to find outcomes for people down the track and their own parents and partners.

"It was a difficult time then because there wasn't anything really much that was positive but I think things are changing now in that we're starting to see some positive outcomes from research."

Future without dementia possible

With a global team of scientists working daily on how to improve treatments for dementia, Dr White says there is "absolutely" hope for a future without the degenerative condition.

"Many decades ago there was no future for people with cancer and when they got diagnosed it was pretty much a death sentence," Dr White says.  

"But now there's lots of great treatments for cancer. 

"I think we're on the verge of that with Alzheimer's and other brain diseases that over the next few years, or decade, we'll see very important treatments that will at least slow the disease down.

"You don't have to slow it by a lot to give people a better quality of life."

Treatment giving hope to younger people

A dementia-free future won't arrive in time for Bridget Smith's father, but she is hopeful it could be something the mother of three gets to enjoy.

Garry Smith was admitted to hospital last year with lung problems but it was there his dementia suddenly and rapidly became impossible to ignore.

Garry and Bridget Smith and Ms Smith's sons, Freddie, Louis and Tommy McGovern. Garry Smith was diagnosed with dementia in 2021. ( Supplied: Bridget Smith )

"He's forgotten things in his past but certainly not things in his present like me and my boys," Ms Smith said, who works in QIMR Berghofer's communications team, says.

"The research that people like Dr Tony White are doing here is incredible.

"And I think he may not be able to save my dad but it's hereditary and my grandmother had Alzheimer's so it's a concern for me as well.

"I'm 43. To think dad's so young at 76 to have dementia, I would hope this research while it can't help dad it can perhaps help my generation."

QIMR Berghofer's dementia research team will host a dementia forum this evening from 5–7pm.

Register online here.

A recording of the event will also be posted to qimrberghofer.edu.au.

Health & Science

World-Class research centre puts the ‘smart’ in Smart State

Qimr berghofer medical research institute.

QIMR Berghofer Medical Research Institute has a long and prestigious history. Established in 1945 by the Queensland Government, it is one of the largest and most successful medical research institutions in Australia; recognised nationally and internationally for the high quality of fundamental and translational research it undertakes. QIMR Berghofer’s vision for ‘better health through medical research’ was realised through the delivery of a leading research hub in Brisbane.

Herston, Queensland

$167 million, 2007 - 2014, wardle and wilson joint venture, managing contractor.

Gross floor area

Storey building

Cost savings to client

Hours worked

Delivering excellence under budget

The new 13-storey world class research facility was delivered in three distinct phases. Following the initial demolition works, construction of the central building took place, which included the laboratories and administration, followed lastly by the refurbishment of the adjacent Bancroft Centre and Clive Berghofer Cancer Research Centre. The sophisticated new facilities enhanced QIMR Berghofer’s capacity to perform world-leading medical research into Indigenous health, cancer, infectious diseases and chronic disorders. It also enabled the introduction of the critical Mental Health Research Division. 

Ensuring safety in a hazardous environment

Demolition of the old Queensland Radium Institute building was required prior to construction. Built in the early 1980s and posing a possible asbestos risk, our team engaged the services of a leading hazardous materials consultant to audit the building. This uncovered varying levels of asbestos in several areas including the exterior sunshades. With precision movements, the panels were removed one at a time, followed by a thorough vacuum process to ensure the complete removal of hazardous debris. While accruing a greater cost and time penalty, this was necessary to guarantee the safety of workers.

Environmentally conscious

Our expertise in live environments was instrumental in our approach to this project. By developing an Environmental Management Plan alongside a Quality Management Plan, we proactively identified all potential issues and were able to mitigate these prior to works commencing. Monitoring for sensitive environmental factors such as air quality and vibration was overseen by our Environmental Officer. Regular and detailed communication with QIMR and other stakeholders ensured all parties remained well informed throughout the project which minimised disruption to their daily operations. 

Value for money

A significant focus for the project team was to deliver the first two stages under budget with the surplus to be directed towards a major refurbishment of the adjacent Bancroft Centre. We proudly delivered this world-class research facility on time and $16 million under budget without compromising quality. 

“I would like to take this opportunity to recognise the excellent standards achieved in the finished facilities and in the minimisation of disruption and nuisance to the Institute’s scientific community and to its neighbours during the carrying out of the works.” Chris Coyne, Acting Chair, QIMR Council

High Commendation Commercial Construction $100 million plus

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KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER

In this article:.

SYDNEY , Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).

Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead product candidate, is a member of the PI3K inhibitor class.

The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.

The terms of the license include standard provisions for an upfront license fee and development milestones related to the initiation of Phase 1, Phase 2 trial, first Phase 3 trial, first product approval.

Commenting on the new license agreement, Kazia CEO, Dr John Friend said: "This is an exciting evolution in our partnership with QIMR Berghofer and an important milestone for not only Kazia's development of paxalisib, but also the company's commercial portfolio as we secure the licence of a significant cancer immunotherapy pathway. We are very pleased to have obtained the potential intellectual property rights around PI3K inhibitors, which is a significant step forward as we continue to explore cancer treatments beyond the brain, including novel therapeutics in solid tumours such as breast cancer."

Professor Fabienne Mackay , Director and CEO of QIMR Berghofer said: "We are pleased to enter this exclusive licence agreement with Kazia following what has been a successful research collaboration over the past two years. We look forward to progressing the clinical development pathway for PI3K inhibitor drugs such as paxalisib under this partnership in the hope of delivering tangible, life-changing benefits to patients."

Kazia's preclinical research collaboration with QIMR Berghofer Medical Research Institute is investigating the use of paxalisib in solid tumours. The ongoing research project is led by Professor Sudha Rao , a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer. Prof Rao is the principal investigator of preclinical studies where paxalisib and KEYTRUDA® combination is used in Triple Negative Breast Cancer, and paxalisib and LYNPARZA® (Olaparib) combination in advanced breast cancer.

Professor Rao's team has demonstrated in preclinical studies that the combination of paxalisib with checkpoint inhibitor blockade resulted in highly consistent and statistically significant signals of efficacy including overall tumour volume, metastases, and inflammatory markers. Furthermore, the addition of paxalisib to immunotherapy was observed to reinvigorate the immune cells within the tumour microenvironment by restoring immune killing function while inhibiting "pro-tumour" immune cells. Further data is expected to be presented at future scientific meetings in 2025.

Commenting on the research, Prof Rao said: "The immune system plays a critical role in fighting against cancer. We urgently need treatments that can make cancer cells visible, and at the same time increase the utility of immunotherapy for metastatic breast cancers. In that sense, paxalisib is an exciting PI3K inhibitor because it not only has been observed to inhibit primary tumour burden but was also observed to reinvigorate the immune system of cancer patients. We look forward to providing a preliminary update in the near future on our findings of using paxalisib in breast cancer."

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia .

Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.

Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018 , and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020 . Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 , and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022 , respectively.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021 . Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and presentation of preliminary data at a medical conference is anticipated in CY2024.

For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, the potential benefits of Kazia's product candidates, including paxalisib, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, risks related to collaborations with third parties, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.

This announcement was authorized for release by Dr John Friend , CEO.

View original content to download multimedia: https://www.prnewswire.com/news-releases/kazia-executes-licensing-agreement-with-qimr-berghofer-302246050.html

SOURCE Kazia Therapeutics Limited

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KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER

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Sep 12, 2024, 07:30 ET

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SYDNEY , Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA ), an oncology-focused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).

Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead product candidate, is a member of the PI3K inhibitor class.

The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.

The terms of the license include standard provisions for an upfront license fee and development milestones related to the initiation of Phase 1, Phase 2 trial, first Phase 3 trial, first product approval. 

Commenting on the new license agreement, Kazia CEO, Dr John Friend said: "This is an exciting evolution in our partnership with QIMR Berghofer and an important milestone for not only Kazia's development of paxalisib, but also the company's commercial portfolio as we secure the licence of a significant cancer immunotherapy pathway. We are very pleased to have obtained the potential intellectual property rights around PI3K inhibitors, which is a significant step forward as we continue to explore cancer treatments beyond the brain, including novel therapeutics in solid tumours such as breast cancer."

Professor Fabienne Mackay , Director and CEO of QIMR Berghofer said: "We are pleased to enter this exclusive licence agreement with Kazia following what has been a successful research collaboration over the past two years. We look forward to progressing the clinical development pathway for PI3K inhibitor drugs such as paxalisib under this partnership in the hope of delivering tangible, life-changing benefits to patients."

Kazia's preclinical research collaboration with QIMR Berghofer Medical Research Institute is investigating the use of paxalisib in solid tumours. The ongoing research project is led by Professor Sudha Rao , a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer. Prof Rao is the principal investigator of preclinical studies where paxalisib and KEYTRUDA® combination is used in Triple Negative Breast Cancer, and paxalisib and LYNPARZA® (Olaparib) combination in advanced breast cancer.

Professor Rao's team has demonstrated in preclinical studies that the combination of paxalisib with checkpoint inhibitor blockade resulted in highly consistent and statistically significant signals of efficacy including overall tumour volume, metastases, and inflammatory markers. Furthermore, the addition of paxalisib to immunotherapy was observed to reinvigorate the immune cells within the tumour microenvironment by restoring immune killing function while inhibiting "pro-tumour" immune cells. Further data is expected to be presented at future scientific meetings in 2025.

Commenting on the research, Prof Rao said: "The immune system plays a critical role in fighting against cancer. We urgently need treatments that can make cancer cells visible, and at the same time increase the utility of immunotherapy for metastatic breast cancers. In that sense, paxalisib is an exciting PI3K inhibitor because it not only has been observed to inhibit primary tumour burden but was also observed to reinvigorate the immune system of cancer patients. We look forward to providing a preliminary update in the near future on our findings of using paxalisib in breast cancer."

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA ) is an oncology-focused drug development company, based in Sydney, Australia .

Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.

Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018 , and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020 . Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 , and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022 , respectively.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021 . Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and presentation of preliminary data at a medical conference is anticipated in CY2024.

For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, the potential benefits of Kazia's product candidates, including paxalisib, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, risks related to collaborations with third parties, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.

This announcement was authorized for release by Dr John Friend , CEO.

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ENIGMA and global neuroscience: A decade of large-scale studies of the brain in health and disease across more than 40 countries

Affiliations.

• 1 Imaging Genetics Center, Mark and Mary Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, CA, USA. [email protected].
• 2 Imaging Genetics Center, Mark and Mary Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, University of Southern California, Marina del Rey, CA, USA.
• 3 Department of Psychiatry, University of Münster, Münster, Germany.
• 4 Department of Psychiatry, The University of Melbourne, Melbourne, VIC, Australia.
• 5 The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, VIC, Australia.
• 6 Department of Psychiatry, Bellvitge University Hospital, Bellvitge Biomedical Research Institute-IDIBELL, Barcelona, Spain.
• 7 Department of Human Genetics, Radboud University Medical Center, Nijmegen, The Netherlands.
• 8 Donders Institute for Brain, Cognition and Behaviour, Radboud University, Nijmegen, The Netherlands.
• 9 Department of Psychiatry, Amsterdam UMC, University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands.
• 10 Institute for Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, Greifswald, Germany.
• 11 Department of Computer Science and Engineering, The Ohio State University, Columbus, OH, USA.
• 12 Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, VIC, Australia.
• 13 Biometris Wageningen University and Research, Wageningen, The Netherlands.
• 14 Language & Genetics Department, Max Planck Institute for Psycholinguistics, Nijmegen, The Netherlands.
• 15 The Center for Neuroimaging and Cognitive Genomics, School of Psychology, National University of Ireland, Galway, Ireland.
• 16 Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.
• 17 Desert-Pacific Mental Illness Research, Education, and Clinical Center, VA San Diego Healthcare System, San Diego, CA, USA.
• 18 Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.
• 19 INSERM Unit 955 Team 15 'Translational Psychiatry', Créteil, France.
• 20 NeuroSpin, UNIACT Lab, Psychiatry Team, CEA Saclay, Gif-Sur-Yvette, France.
• 21 National Institute of Mental Health, National of Health, Bethesda, MD, USA.
• 22 Department of Psychiatry and Psychotherapy, Otto von Guericke University Magdeburg, Magdeburg, Germany.
• 23 Department of Psychiatry, Trinity College Dublin, Dublin, Ireland.
• 24 German Center for Neurodegenerative Diseases (DZNE), Magdeburg, Germany.
• 25 Information Sciences Institute, University of Southern California, Marina del Rey, CA, USA.
• 26 Department of Computer Science, University of Southern California, Los Angeles, CA, USA.
• 27 Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.
• 28 German Center for Neurodegenerative Diseases (DZNE), Site Rostock/Greifswald, Greifswald, Germany.
• 29 Psychiatric Genetics, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.
• 30 Department of Psychiatry, Dalhousie University, Halifax, NS, Canada.
• 31 National Institute of Mental Health, Klecany, Czech Republic.
• 32 Department of Psychiatry, Amsterdam University Medical Centers, VU University Medical Center, GGZ inGeest, Amsterdam Neuroscience, Amsterdam, The Netherlands.
• 33 Center for Multimodal Imaging and Genetics, University of California, San Diego, La Jolla, CA, USA.
• 34 Brain and Mind Centre, University of Sydney, Sydney, Australia.
• 35 Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.
• 36 Department of Psychiatry & Behavioral Sciences, Stanford University, Stanford, CA, USA.
• 37 Department of Psychiatry & Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, USA.
• 38 Interfaculty Institute for Genetics and Functional Genomics, University Medicine Greifswald, Greifswald, Germany.
• 39 APHP, Mondor University Hospitals, School of Medicine, DMU Impact, Psychiatry Department, Créteil, France.
• 40 Icahn School of Medicine at Mount Sinai, New York, NY, USA.
• 41 Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University, Shanghai, China.
• 42 MOE Key Laboratory of Computational Neuroscience and Brain-Inspired Intelligence, Fudan University, Shanghai, China.
• 43 Centre for Population Neuroscience and Precision Medicine (PONS), MRC SGDP Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
• 44 Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
• 45 Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.
• 46 Department of Psychiatry, UMC Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
• 47 Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of Korea.
• 48 Department of Brain and Cognitive Sciences, Seoul National University College of Natural Sciences, Seoul, Republic of Korea.
• 49 Department of Anatomy & Neurosciences, Amsterdam UMC, Location VUmc, Amsterdam Neuroscience, Amsterdam, The Netherlands.
• 50 Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Amsterdam, The Netherlands.
• 51 Faculty of Computer Science, Dalhousie University, Halifax, NS, Canada.
• 52 Child & Adolescent Psychiatry, University of California, Los Angeles, Los Angeles, CA, USA.
• 53 Laboratory of Neuropsychiatry, IRCCS Santa Lucia Foundation, Rome, Italy.
• 54 Melbourne Neuropsychiatry Centre, Department of Psychiatry, The University of Melbourne, Melbourne, VIC, Australia.
• 55 Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, VIC, Australia.
• 56 CIBERSAM-G17, Madrid, Spain.
• 57 Department of Psychobiology and Methodology in Health Sciences, Universitat Autònoma de Barcelona, Barcelona, Spain.
• 58 Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
• 59 Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, Los Angeles, CA, USA.
• 60 Department of Mental Health, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA.
• 61 Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany.
• 62 Stanley Center for Psychiatric Research, The Broad Institute, Cambridge, MA, USA.
• 63 Analytic and Translational Genetics Unit, Massachusetts General Hospital, Boston, MA, USA.
• 64 Psychiatry and Integrative Neurophysiology, VU University, Amsterdam UMC, Amsterdam, The Netherlands.
• 65 German Centre for Cardiovascular Research, Partner Site Greifswald, Greifswald, Germany.
• 66 Department of Psychology, University of Bath, Bath, UK.
• 67 Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
• 68 Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
• 69 Queensland Brain Institute, University of Queensland, Brisbane, QLD, Australia.
• 70 Centre for Advanced Imaging, University of Queensland, Brisbane, QLD, Australia.
• 71 Seoul National University Hospital, Seoul, Republic of Korea.
• 72 Yeongeon Student Support Center, Seoul National University College of Medicine, Seoul, Republic of Korea.
• 73 Department of Computer Science and Electrical Engineering, University of Maryland, Baltimore County, MD, USA.
• 74 Department of Psychiatry and Behavioral Sciences, SUNY Upstate Medical University, Syracuse, NY, USA.
• 75 Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.
• 76 Norwegian Centre for Mental Disorders Research (NORMENT), Division of Mental Health & Addiction, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
• 77 Department of Clinical Neuroscience, Centre for Psychiatric Research, Karolinska Institutet, Stockholm, Sweden.
• 78 Department of Psychiatric Research, Diakonhjemmet Hospital, Oslo, Norway.
• 79 Department of Psychiatry, Amsterdam UMC, Location VUmc, Amsterdam Neuroscience, Amsterdam, The Netherlands.
• 80 Department of Research & Innovation, GGZ InGeest, Amsterdam, The Netherlands.
• 81 University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
• 82 Psychiatry, Pediatrics, and Psychological Sciences, University of Vermont, Burlington, VT, USA.
• 83 Centre for Medical Image Computing (CMIC), Department of Medical Physics and Biomedical Engineering, University College London, London, UK.
• 84 Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.
• 85 Provost and Senior Vice President, Western University of Health Sciences, Pomona, CA, USA.
• 86 Department of Radiology, Loma Linda University Medical Center, Loma Linda, CA, USA.
• 87 Institute of Psychology, Leiden University, Leiden, The Netherlands.
• 88 Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.
• 89 Leiden Institute for Brain and Cognition, Leiden, The Netherlands.
• 90 Department of Psychology, Yale University, New Haven, CT, USA.
• 91 Department of Psychology, University of California, Los Angeles, CA, USA.
• 92 Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.
• 93 Cognitive Neuroscience Unit, School of Psychology, Deakin University, Burwood, VIC, Australia.
• 94 Department of Child and Adolescent Psychiatry/Psychology, Erasmus Medical Centre, Rotterdam, The Netherlands.
• 95 Department of Epidemiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
• 96 Center for Cognitive Aging and Memory, University of Florida, Gainesville, FL, USA.
• 97 Clinical and Health Psychology, Gainesville, FL, USA.
• 98 Centre for Medical Image Computing (CMIC), Department of Computer Science, University College London, London, UK.
• 99 Dementia Research Centre, Institute of Neurology, University College London, London, UK.
• 100 Universite de Montreal, Centre de Recherche CHU Ste-Justine, Montreal, QC, Canada.
• 101 School of Psychology and Centre for Human Brain Health, University of Birmingham, Birmingham, UK.
• 102 Department of Neurology, University of Utah, Salt Lake City, UT, USA.
• 103 Psychiatry Neuroimaging Laboratory, Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA.
• 104 Social, Genetic & Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
• 105 Department of Psychology, School of Arts and Social Sciences, City, University of London, London, UK.
• 106 Department of Neuroimaging, Institute of Psychology, Psychiatry and Neurosciences, King's College London, London, UK.
• 107 Division of Psychological and Social Medicine and Developmental Neurosciences, Faculty of Medicine, TU Dresden, Dresden, Germany.
• 108 Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers Biomedical Health Sciences, Newark, NJ, USA.
• 109 Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
• 110 SU/UCT MRC Unit on Risk & Resilience in Mental Disorders, University of Stellenbosch, Stellenbosch, South Africa.
• 111 Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
• 112 University of British Columbia, Vancouver, Canada.
• 113 Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.
• 114 Department of Psychiatry, University of Vermont, Burlington, VT, USA.
• 115 Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.
• 116 Olin Neuropsychiatric Research Center, Institute of Living, Hartford, CT, USA.
• 117 Biomedical Engineering, Illinois Institute of Technology, Chicago, IL, USA.
• 118 Institute for Information Transmission Problems, Kharkevich Institute, Moscow, Russian Federation.
• 119 Turner Institute for Brain and Mental Health & School of Psychological Sciences, Monash University, Melbourne, VIC, Australia.
• 120 Department of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
• 121 Genentech, Inc., South San Francisco, CA, USA.
• 122 Department of Psychology, Penn State University, University Park, PA, USA.
• 123 Social Life and Engineering Sciences Imaging Center, University Park, PA, USA.
• 124 Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
• 125 Research and Scientific Institute of Pediatrics and Child Health, CCH RAS, Ministry of Science and Higher Education, Moscow, Russian Federation.
• 126 Department of Pediatrics, Michigan State University, East Lansing, MI, USA.
• 127 Institute for Quantitative Health Science and Engineering, East Lansing, MI, USA.
• 128 Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
• 129 CBRAIN, Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Ludwig-Maximilians-Universität München, Munich, Germany.
• 130 Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
• 131 Chan Division of Occupational Science and Occupational Therapy, Los Angeles, CA, USA.
• 132 Center for Clinical Spectroscopy, Brigham and Women's Hospital, Boston, MA, USA.
• 133 Harvard Medical School, Boston, MA, USA.
• 134 National Center for PTSD at Boston VA Healthcare System, Boston, MA, USA.
• 135 Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.
• 136 Biomedical Genetics, Boston University School of Medicine, Boston, MA, USA.
• 137 School of Psychology, University of Auckland, Auckland, New Zealand.
• 138 Laboratory of Neuro Imaging, Mark and Mary Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
• 139 Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine, CA, USA.
• 140 Mind Research Network, Albuquerque, NM, USA.
• 141 Psychiatry, San Diego, CA, USA.
• 142 The Kavli Foundation, Los Angeles, CA, USA.
• 143 Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
• 144 Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA.
• 145 Mental Illness Research Education and Clinical Center, Durham VA Medical Center, Durham, NC, USA.
• 146 Experimental Clinical & Health Psychology, Ghent University, Ghent, Belgium.
• 147 Department of Personality, Psychological Assessment and Treatment, University of Deusto, Bilbao, Spain.
• 148 Radiology and Biomedical Imaging, San Francisco, CA, USA.
• 149 Department of Pediatrics, Russian National Research Medical University MoH RF, Moscow, Russian Federation.
• 150 Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.
• 151 Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
• 152 Biological Sciences, Purdue University, West Lafayette, IN, USA.
• 153 National Institute of Mental Health Intramural Research Program, Bethesda, MD, USA.
• 154 Department of Genetics and Computational Biology, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.
• 155 Department of Neurodegenerative Disease, UCL Queen Square Institute of Neurology, London, UK.
• 156 Max Planck Institute of Psychiatry, Munich, Germany.
• 157 Centre for Youth Mental Health, The University of Melbourne, Melbourne, VIC, Australia.
• 158 Department of Psychiatry and Psychotherapy, Charite, Humboldt University, Berlin, Germany.
• 159 Department of Radiology, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, USA.
• 160 Department of Clinical and Experimental Epilepsy, University College London, London, UK.
• 161 Chalfont Centre for Epilepsy, Chalfont St Peter, UK.
• 162 Department of Medical Genetics, Oslo University Hospital, Oslo, Norway.
• 163 Department of Psychiatry & Neuroscience Institute, SA MRC Unit on Risk & Resilience in Mental Disorders, Cape Town, South Africa.
• 164 Department of Genetics & UNC Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
• 165 Institute of Medical Science and Technology, Shahid Beheshti University, Tehran, I. R., Iran.
• 166 Department of Neurology, TBI and Concussion Center, Salt Lake City, UT, USA.
• 167 Missouri Institute of Mental Health, Berkeley, MO, USA.
• 168 Psychology Department & Neuroscience Institute, Georgia State University, Atlanta, GA, USA.
• 169 Clinical Translational Neuroscience Laboratory, Department of Psychiatry and Human Behavior, University of California Irvine, Irvine, CA, USA.
• 170 Center for the Neurobiology of Learning and Memory, University of California, Irvine, Irvine, CA, USA.
• 171 Donders Centre for Cognitive Neuroimaging, Radboud University Medical Centre, Nijmegen, The Netherlands.
• 172 Division of Mind and Brain Research, Department of Psychiatry and Psychotherapy CCM, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
• 173 Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, Dublin, Ireland.
• 174 Research and Early Development, Biogen Inc, Cambridge, MA, USA.
• 175 VA Salt Lake City Healthcare System, Salt Lake City, UT, USA.
• 176 Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.
• 177 Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
• 178 Skolkovo Institute of Science and Technology, Moscow, Russian Federation.
• PMID: 32198361
• PMCID: PMC7083923
• DOI: 10.1038/s41398-020-0705-1

This review summarizes the last decade of work by the ENIGMA (Enhancing NeuroImaging Genetics through Meta Analysis) Consortium, a global alliance of over 1400 scientists across 43 countries, studying the human brain in health and disease. Building on large-scale genetic studies that discovered the first robustly replicated genetic loci associated with brain metrics, ENIGMA has diversified into over 50 working groups (WGs), pooling worldwide data and expertise to answer fundamental questions in neuroscience, psychiatry, neurology, and genetics. Most ENIGMA WGs focus on specific psychiatric and neurological conditions, other WGs study normal variation due to sex and gender differences, or development and aging; still other WGs develop methodological pipelines and tools to facilitate harmonized analyses of "big data" (i.e., genetic and epigenetic data, multimodal MRI, and electroencephalography data). These international efforts have yielded the largest neuroimaging studies to date in schizophrenia, bipolar disorder, major depressive disorder, post-traumatic stress disorder, substance use disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, autism spectrum disorders, epilepsy, and 22q11.2 deletion syndrome. More recent ENIGMA WGs have formed to study anxiety disorders, suicidal thoughts and behavior, sleep and insomnia, eating disorders, irritability, brain injury, antisocial personality and conduct disorder, and dissociative identity disorder. Here, we summarize the first decade of ENIGMA's activities and ongoing projects, and describe the successes and challenges encountered along the way. We highlight the advantages of collaborative large-scale coordinated data analyses for testing reproducibility and robustness of findings, offering the opportunity to identify brain systems involved in clinical syndromes across diverse samples and associated genetic, environmental, demographic, cognitive, and psychosocial factors.

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Conflict of interest statement

Individual authors’ disclosures and conflicts of interest are listed in Supplementary Appendix C .

Fig. 1. World Map of ENIGMA’s Working…

Fig. 1. World Map of ENIGMA’s Working Groups.

The ENIGMA Consortium has grown to include…

Fig. 2. ENIGMA’s Working Group Flowchart.

ENIGMA’s working groups are divided into technical groups that…

Fig. 3. Genetic Influences on brain structure:…

Fig. 3. Genetic Influences on brain structure: effects of common and rare genetic variants.

Fig. 4. ENIGMA’s large-scale studies of nine…

Fig. 4. ENIGMA’s large-scale studies of nine brain disorders.

Cortical gray matter thickness abnormalities as…

Fig. 5. Subcortical abnormalities in schizophrenia, bipolar…

Fig. 5. Subcortical abnormalities in schizophrenia, bipolar disorder, major depressive disorder, and ADHD.

Fig. 6. White matter microstructure in schizophrenia,…

Fig. 6. White matter microstructure in schizophrenia, major depressive disorder, and 22q11.2 deletion syndrome.

Fig. 7. Topology of large-scale scientific collaboration.

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• The Enhancing NeuroImaging Genetics through Meta-Analysis Consortium: 10 Years of Global Collaborations in Human Brain Mapping. Thompson PM, Jahanshad N, Schmaal L, Turner JA, Winkler AM, Thomopoulos SI, Egan GF, Kochunov P. Thompson PM, et al. Hum Brain Mapp. 2022 Jan;43(1):15-22. doi: 10.1002/hbm.25672. Epub 2021 Oct 6. Hum Brain Mapp. 2022. PMID: 34612558 Free PMC article.
• The ENIGMA Consortium: large-scale collaborative analyses of neuroimaging and genetic data. Thompson PM, Stein JL, Medland SE, Hibar DP, Vasquez AA, Renteria ME, Toro R, Jahanshad N, Schumann G, Franke B, Wright MJ, Martin NG, Agartz I, Alda M, Alhusaini S, Almasy L, Almeida J, Alpert K, Andreasen NC, Andreassen OA, Apostolova LG, Appel K, Armstrong NJ, Aribisala B, Bastin ME, Bauer M, Bearden CE, Bergmann O, Binder EB, Blangero J, Bockholt HJ, Bøen E, Bois C, Boomsma DI, Booth T, Bowman IJ, Bralten J, Brouwer RM, Brunner HG, Brohawn DG, Buckner RL, Buitelaar J, Bulayeva K, Bustillo JR, Calhoun VD, Cannon DM, Cantor RM, Carless MA, Caseras X, Cavalleri GL, Chakravarty MM, Chang KD, Ching CR, Christoforou A, Cichon S, Clark VP, Conrod P, Coppola G, Crespo-Facorro B, Curran JE, Czisch M, Deary IJ, de Geus EJ, den Braber A, Delvecchio G, Depondt C, de Haan L, de Zubicaray GI, Dima D, Dimitrova R, Djurovic S, Dong H, Donohoe G, Duggirala R, Dyer TD, Ehrlich S, Ekman CJ, Elvsåshagen T, Emsell L, Erk S, Espeseth T, Fagerness J, Fears S, Fedko I, Fernández G, Fisher SE, Foroud T, Fox PT, Francks C, Frangou S, Frey EM, Frodl T, Frouin V, Garavan H, Giddaluru S, Glahn DC, Godlewska B, Goldstein RZ, Gollub RL, Grabe HJ, Grimm O, Gruber O, Guadalupe T, Gur RE, Gur RC, Göring HH, Ha… See abstract for full author list ➔ Thompson PM, et al. Brain Imaging Behav. 2014 Jun;8(2):153-82. doi: 10.1007/s11682-013-9269-5. Brain Imaging Behav. 2014. PMID: 24399358 Free PMC article. Review.
• Effects of copy number variations on brain structure and risk for psychiatric illness: Large-scale studies from the ENIGMA working groups on CNVs. Sønderby IE, Ching CRK, Thomopoulos SI, van der Meer D, Sun D, Villalon-Reina JE, Agartz I, Amunts K, Arango C, Armstrong NJ, Ayesa-Arriola R, Bakker G, Bassett AS, Boomsma DI, Bülow R, Butcher NJ, Calhoun VD, Caspers S, Chow EWC, Cichon S, Ciufolini S, Craig MC, Crespo-Facorro B, Cunningham AC, Dale AM, Dazzan P, de Zubicaray GI, Djurovic S, Doherty JL, Donohoe G, Draganski B, Durdle CA, Ehrlich S, Emanuel BS, Espeseth T, Fisher SE, Ge T, Glahn DC, Grabe HJ, Gur RE, Gutman BA, Haavik J, Håberg AK, Hansen LA, Hashimoto R, Hibar DP, Holmes AJ, Hottenga JJ, Hulshoff Pol HE, Jalbrzikowski M, Knowles EEM, Kushan L, Linden DEJ, Liu J, Lundervold AJ, Martin-Brevet S, Martínez K, Mather KA, Mathias SR, McDonald-McGinn DM, McRae AF, Medland SE, Moberget T, Modenato C, Monereo Sánchez J, Moreau CA, Mühleisen TW, Paus T, Pausova Z, Prieto C, Ragothaman A, Reinbold CS, Reis Marques T, Repetto GM, Reymond A, Roalf DR, Rodriguez-Herreros B, Rucker JJ, Sachdev PS, Schmitt JE, Schofield PR, Silva AI, Stefansson H, Stein DJ, Tamnes CK, Tordesillas-Gutiérrez D, Ulfarsson MO, Vajdi A, van 't Ent D, van den Bree MBM, Vassos E, Vázquez-Bourgon J, Vila-Rodriguez F, Walters GB, Wen W, Westlye LT, Wittf… See abstract for full author list ➔ Sønderby IE, et al. Hum Brain Mapp. 2022 Jan;43(1):300-328. doi: 10.1002/hbm.25354. Epub 2021 Feb 21. Hum Brain Mapp. 2022. PMID: 33615640 Free PMC article. Review.
• Neuroimaging studies within Cognitive Genetics Collaborative Research Organization aiming to replicate and extend works of ENIGMA. Koshiyama D, Miura K, Nemoto K, Okada N, Matsumoto J, Fukunaga M, Hashimoto R. Koshiyama D, et al. Hum Brain Mapp. 2022 Jan;43(1):182-193. doi: 10.1002/hbm.25040. Epub 2020 Jun 5. Hum Brain Mapp. 2022. PMID: 32501580 Free PMC article. Review.
• How do substance use disorders compare to other psychiatric conditions on structural brain abnormalities? A cross-disorder meta-analytic comparison using the ENIGMA consortium findings. Navarri X, Afzali MH, Lavoie J, Sinha R, Stein DJ, Momenan R, Veltman DJ, Korucuoglu O, Sjoerds Z, van Holst RJ, Hester R, Orr C, Cousijn J, Yucel M, Lorenzetti V, Wiers R, Jahanshad N, Glahn DC, Thompson PM, Mackey S, Conrod PJ. Navarri X, et al. Hum Brain Mapp. 2022 Jan;43(1):399-413. doi: 10.1002/hbm.25114. Epub 2020 Jul 9. Hum Brain Mapp. 2022. PMID: 32643841 Free PMC article.
• A federated learning architecture for secure and private neuroimaging analysis. Stripelis D, Gupta U, Saleem H, Dhinagar N, Ghai T, Anastasiou C, Sánchez R, Steeg GV, Ravi S, Naveed M, Thompson PM, Ambite JL. Stripelis D, et al. Patterns (N Y). 2024 Aug 1;5(8):101031. doi: 10.1016/j.patter.2024.101031. eCollection 2024 Aug 9. Patterns (N Y). 2024. PMID: 39233693 Free PMC article.
• Machine Learning and Deep Learning Approaches in Lifespan Brain Age Prediction: A Comprehensive Review. Wu Y, Gao H, Zhang C, Ma X, Zhu X, Wu S, Lin L. Wu Y, et al. Tomography. 2024 Aug 12;10(8):1238-1262. doi: 10.3390/tomography10080093. Tomography. 2024. PMID: 39195728 Free PMC article. Review.
• Automatic rating of incomplete hippocampal inversions evaluated across multiple cohorts. Hemforth L, Couvy-Duchesne B, De Matos K, Brianceau C, Joulot M, Banaschewski T, Bokde ALW, Desrivières S, Flor H, Grigis A, Garavan H, Gowland P, Heinz A, Brühl R, Martinot JL, Paillère Martinot ML, Artiges E, Papadopoulos D, Lemaitre H, Paus T, Poustka L, Hohman S, Holz N, Fröhner JH, Smolka MN, Vaidya N, Walter H, Whelan R, Schumann G, Büchel C, Poline JB, Itterman B, Frouin V, Martin A; IMAGEN study group; Cury C, Colliot O. Hemforth L, et al. ArXiv [Preprint]. 2024 Aug 5:arXiv:2408.02496v1. ArXiv. 2024. PMID: 39148932 Free PMC article. Updated. Preprint.
• ComBatLS: A location- and scale-preserving method for multi-site image harmonization. Gardner M, Shinohara RT, Bethlehem RAI, Romero-Garcia R, Warrier V, Dorfschmidt L; Lifespan Brain Chart Consortium; Shanmugan S, Thompson P, Seidlitz J, Alexander-Bloch AF, Chen AA. Gardner M, et al. bioRxiv [Preprint]. 2024 Jul 30:2024.06.21.599875. doi: 10.1101/2024.06.21.599875. bioRxiv. 2024. PMID: 39131292 Free PMC article. Preprint.
• Current best practices and future opportunities for reproducible findings using large-scale neuroimaging in psychiatry. Jahanshad N, Lenzini P, Bijsterbosch J. Jahanshad N, et al. Neuropsychopharmacology. 2024 Aug 8. doi: 10.1038/s41386-024-01938-8. Online ahead of print. Neuropsychopharmacology. 2024. PMID: 39117903 Review.
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Press Release

Versiti blood research institute breaks ground on expansion, new renderings of vbri addition released.

The Versiti Blood Research Institute (VBRI), recognized as one of the world's premier blood health research centers, announced its expansion plans are moving forward at a ceremonial groundbreaking, located at 8727 West Watertown Plank Road at the Milwaukee Regional Medical Center campus in Wauwatosa. Construction on the expansion project is scheduled to begin this month with an estimated completion date in 2026. New renderings of the VBRI addition were released to the public at the event. The project is expected to have a total economic impact for the state of more than half a billion dollars by 2050. HGA is serving as the architect and Mortenson is the general contractor for the new facility.

Versiti’s president and chief executive officer Chris Miskel was joined by Wisconsin Assembly Speaker Robin Vos; Mayor of Wauwatosa Dennis McBride; Bob Simi, executive director of the Milwaukee Regional Medical Center; Jeff Gruhn, director of project development for Mortenson’s Wisconsin Operations; and approximately 100 community leaders to celebrate the additional services and research that this expansion will provide to the community and to the rest of the world.

The expansion is a state-of-the-art 79,000 square-foot addition that will nearly double VBRI’s research capacity, add approximately 100 new jobs and generate an estimated $19 million in additional tax revenue for the state of Wisconsin over 30 years. The new addition will expand the VBRI's research capacity and promote the discovery of novel, more effective and less toxic therapies for a broad range of conditions that affect millions, positively impacting the health of residents across the state, nation and international community.

“Today, we celebrate a pivotal moment for the future of blood health as we break ground on the $79 million expansion of the Versiti Blood Research Institute,” said Chris Miskel, president and CEO of Versiti. “This new, world-class facility will open in Wisconsin during 2026.  We will attract leading scientific minds and fuel groundbreaking research, turning discoveries into lifesaving treatments that transform patient care worldwide.”

The VBRI is nearing capacity and plans to expand its current team of 31 principal scientists to approximately 50 in the next 5-7 years. Each new scientist will bring a team of up to 10 new colleagues, exponentially increasing the research community and enhancing the culture of collaboration.

The expansion is a $79 million project that will include donations and private funding. The State Building Commission released $10 million to support the VBRI’s plans to build the addition, reaffirming the state’s commitment to advancing blood health research.

Versiti is a 501(c)(3) not-for-profit headquartered in Milwaukee, with more than 2,200 employees at its locations in Illinois, Indiana, Michigan, Ohio, Texas and Wisconsin. Learn more at Versiti.org/InvestinginHope .

About Versiti

Versiti is a world-class blood health organization with locations across the Midwest. Headquartered in Milwaukee, Versiti was formed with a mission of service to improve patient outcomes, advance the field of personalized medicine and strengthen the health of communities everywhere. We are deeply rooted in the communities we serve, providing innovative, value-added solutions in the fields of transfusion medicine, transplantation, and blood-related diseases. From research and diagnostic testing to the sharing of lifesaving gifts through blood, organ and tissue donation, the collective efforts across Versiti result in more hope for the communities that trust us. For more information, visit Versiti.org .

ALERT: Wisconsin Experiencing Emergency Blood Shortage

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Kazia Therapeutics Limited

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Kazia executes licensing agreement with qimr berghofer.

SYDNEY , Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).

Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead product candidate, is a member of the PI3K inhibitor class.

The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.

The terms of the license include standard provisions for an upfront license fee and development milestones related to the initiation of Phase 1, Phase 2 trial, first Phase 3 trial, first product approval.

Commenting on the new license agreement, Kazia CEO, Dr John Friend said: "This is an exciting evolution in our partnership with QIMR Berghofer and an important milestone for not only Kazia's development of paxalisib, but also the company's commercial portfolio as we secure the licence of a significant cancer immunotherapy pathway. We are very pleased to have obtained the potential intellectual property rights around PI3K inhibitors, which is a significant step forward as we continue to explore cancer treatments beyond the brain, including novel therapeutics in solid tumours such as breast cancer."

Professor Fabienne Mackay , Director and CEO of QIMR Berghofer said: "We are pleased to enter this exclusive licence agreement with Kazia following what has been a successful research collaboration over the past two years. We look forward to progressing the clinical development pathway for PI3K inhibitor drugs such as paxalisib under this partnership in the hope of delivering tangible, life-changing benefits to patients."

Kazia's preclinical research collaboration with QIMR Berghofer Medical Research Institute is investigating the use of paxalisib in solid tumours. The ongoing research project is led by Professor Sudha Rao , a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer. Prof Rao is the principal investigator of preclinical studies where paxalisib and KEYTRUDA® combination is used in Triple Negative Breast Cancer, and paxalisib and LYNPARZA® (Olaparib) combination in advanced breast cancer.

Professor Rao's team has demonstrated in preclinical studies that the combination of paxalisib with checkpoint inhibitor blockade resulted in highly consistent and statistically significant signals of efficacy including overall tumour volume, metastases, and inflammatory markers. Furthermore, the addition of paxalisib to immunotherapy was observed to reinvigorate the immune cells within the tumour microenvironment by restoring immune killing function while inhibiting "pro-tumour" immune cells. Further data is expected to be presented at future scientific meetings in 2025.

Commenting on the research, Prof Rao said: "The immune system plays a critical role in fighting against cancer. We urgently need treatments that can make cancer cells visible, and at the same time increase the utility of immunotherapy for metastatic breast cancers. In that sense, paxalisib is an exciting PI3K inhibitor because it not only has been observed to inhibit primary tumour burden but was also observed to reinvigorate the immune system of cancer patients. We look forward to providing a preliminary update in the near future on our findings of using paxalisib in breast cancer."

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia .

Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.

Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018 , and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020 . Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 , and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022 , respectively.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021 . Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and presentation of preliminary data at a medical conference is anticipated in CY2024.

For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, the potential benefits of Kazia's product candidates, including paxalisib, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, risks related to collaborations with third parties, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.

This announcement was authorized for release by Dr John Friend , CEO.

SOURCE Kazia Therapeutics Limited

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