Made at MIPS: recent commercialisation successes

For the last 14 years, the innovative entrepreneurial research emerging from Monash Institute of Pharmaceutical Sciences has been making headlines. Several of its ventures have become commercial success stories, attracting millions in grants and investment.

When Monash Institute of Pharmaceutical Sciences (MIPS) was established in 2008, it aimed to be more than just a traditional research arm of the newly established Faculty of Pharmacy and Pharmaceutical Sciences. Following an innovative research model, MIPS was designed to facilitate industry collaboration, foster multidisciplinary research teams and incubate new commercial opportunities. And, in the 14 years since it was founded, it has been doing exactly that.

MIPS has made a huge impact, continually differentiating itself through its entrepreneurship and novel solutions. This has helped it attract large-scale financial investment and grants, taking Monash's research and expertise to the next level and allowing it to forge a reputation as a world-leading research institute.

A boom in biotech

Some of the success stories to emerge over the past few years as part of a MIPS biotech boom include:

  • licensing a lymphatic drug targeting technology platform to the clinical-stage biopharmaceutical company PureTech Health plc in 2017
  • the launch of Cincera Therapeutics in 2018 to discover and develop new drugs to treat inflammatory and fibrotic diseases
  • several MIPS CDCO collaborations with the Medicines for Malaria Venture (MMV) that have progressed into trials, and
  • MIPS professor Colin Pouton’s team becoming the first in Australia to use mRNA science to produce three new vaccine candidates for COVID-19.

This year, several MIPS projects have attracted significant funding, grants and investments:

Septerna Inc. attracts US$100 million Series A financing

Professor Arthur Christopoulos FAA FAHMS, Professor Patrick Sexton, Professor Denise Wootten

L-R: Professor Arthur Christopoulos FAA FAHMS, Professor Patrick Sexton and Professor Denise Wootten

Biotech company Septerna Inc., attracted US$100 million (AU$140 million) Series A financing in 2022.

Septerna Inc. was co-founded by Professor Arthur Christopoulos, Dean of the Faculty of Pharmacy and Pharmaceutical Sciences and Professor Patrick Sexton, Director of the ARC Centre for Cryo-electron Microscopy of Membrane Proteins, with Nobel laureate Professor Robert Lefkowitz, from Duke University. Professor Denise Wootten from MIPS is a Scientific Advisor.

Septerna Inc’s remit is to discover and advance novel small molecule medicines targeting G protein-coupled receptors (GPCRs). While GPCRs are the largest and most diverse family of cell membrane receptors and have been widely studied, the complexity and transmembrane nature of GPCRs have made them difficult to isolate outside of the cell. This makes them inaccessible to modern small-molecule drug discovery approaches.

Septerna Inc has developed a proprietary technology, the GPCR Native Complex™ Platform, to overcome challenges involved in reaching the untapped potential of GPCR drug targets for a wide range of diseases.

“We are delighted to be on the launchpad for what will be a major step-change for GPCR drug discovery,” said Professor Sexton at the time of the funding announcement. “Our teams at MIPS have made deep and impactful advances in understanding novel modes of GPCR drug action, as well as field-leading applications of cryo-electron microscopy to delineating molecular details of GPCR structure and dynamics.”

“The combination of our expertise with the pioneering work of the Lefkowitz laboratory in defining universal mechanisms underpinning GPCR structure, function and regulation bring together decades of innovation for application to a truly novel drug discovery platform,” added Professor Christopoulos.

“The depth and breadth of expertise assembled around Septerna is incredible and ensures the ability to span all aspects of GPCR science and pharmacology.”

A strategic vision to collaborate and innovate

MIPS’s work is focused on five research themes: Drug Discovery Biology (DDB), Medicinal Chemistry, The Centre for Drug Candidate Optimisation (CDCO), Drug Delivery, Disposition and Dynamics (D4), and the Centre for Medicine Use and Safety (CMUS).

In 2020, three Therapeutic Program Areas (TPAs) were introduced to link researchers from different backgrounds. This should encourage them to work together on specific diseases and challenges in the fields of neuroscience and mental health, cardiovascular and metabolic health, and global health.

OmegaOne Therapeutics fights inflammation

Biotech start-up OmegaOne Therapeutics is a partnership between ANU and MIPS to develop a method to block inflammation caused by a number of common diseases. These include cardiovascular disease, Parkinson’s, type 2 diabetes and severe asthma.

In 2022, OmegaOne Therapeutics was awarded a $500,000 grant from CUREator, a national biomedical incubator managed by life science collaboration Brandon BioCatalyst and backed by the Australian Federal Government’s Medical Research Future Fund.

OmegaOne Therapeutics is also supported by Monash University, which will invest approximately $200,000 to cover additional costs and provide support to help the companies to grow and attract further investment. Four other Monash grant recipients also received funding from CUREator.

Phrenix Therapeutics identifying effective treatments for schizophrenia

Professor Chris Langmead and Dr Gregory Stewart

Professor Chris Langmead (left) and Dr Gregory Stewart

Phrenix Therapeutics is a spin-off from the Neuromedicines Discovery Centre (NDC), which was launched within MIPS in late 2021 to drive novel psychiatric drug discovery for the treatment of mental health disorders. With a particular focus on schizophrenia, Phrenix Therapeutics was another recipient of CUREator funding in 2022.

CUREator identified Phrenix as an early-stage biomedical innovation with long-term potential. This was due to the group's use of a unique platform encompassing medicinal chemistry, structural biology, analytical pharmacology and clinically-relevant preclinical testing to identify new approaches to improve cognition.

Phrenix Therapeutics Chief Scientific Officer, Dr Gregory Stewart, a Senior Research Fellow with the NDC, said there are currently no effective treatments for impaired cognition in patients living with schizophrenia.

“Approximately 85 per cent of patients with schizophrenia have impaired cognition, and its severity remains the best predictor of their prognosis. However, the development of new safe and effective treatments has remained stagnant,” he said.

“This funding will help to enable our team to bring together the knowledge and skill-set of MIPS researchers across the drug development pipeline to identify new drug approaches to improve cognition, particularly for those living with schizophrenia.”

The Phrenix Therapeutics MIPS team also includes Chief Executive Officer, Professor Chris Langmead, Professor Denise Wootten, Dr David Shackleford, who work in collaboration with the Florey Institute of Neuroscience and Mental Health.

Phrenix Therapeutics received a $200,000 investment from Monash University. Therapeutic Innovation Australia has also provided ongoing support, along with the MIPS Commercialisation Incubator Fund.

Ankere Therapeutics potential for a global impact on inflammatory lung disease

MIPS Medicinal Chemist, Associate Professor Bernard Flynn is CEO, Research Director and co-founder of Australian biotech company, Ankere Therapeutics, which launched in May 2022 with a $10 million seed investment.

Ankere Therapeutics aims to develop new therapies for inflammatory lung disease using its proprietary small molecule chemistry. The company is harnessing research from a decades-long collaboration between Associate Professor Flynn and Professor Stuart Pitson from the University of South Australia’s Centre for Cancer Biology.

Ankere shows the tangible impact collaborative university research can have on some of the world’s most significant health issues.

Associate Professor Bernard Flynn
Associate Professor Bernard Flynn

“Inflammatory lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension and pulmonary fibrosis can be very debilitating and are lead causes of death worldwide,” said Associate Professor Flynn at the time of the funding announcement.

“We are excited to be developing disease-modifying therapies that have the potential to have a real global impact.”

The funding round was jointly led by IP Group. Brandon Capital, via Brandon BioCatalyst, will support the company through its preclinical development and into clinical trials.

Inhaled Oxytocin Project receives funding to reduce maternal mortality

Inhaled Oxytocin Project team: Dr Tri-Hung Nguyen, Dr Andrew McArthur, Professor Michelle McIntosh, Professor Carl Kirkpatrick, Nicole McMillan, Pete Lambert

Inhaled Oxytocin Project team. L-R: Dr Tri-Hung Nguyen, Dr Andrew McArthur, Professor Michelle McIntosh, Professor Carl Kirkpatrick, Nicole McMillan, Pete Lambert

Another groundbreaking MIPS research initiative, the Inhaled Oxytocin Project, aims to prevent postpartum haemorrhage, the leading cause of maternal mortality globally. In early 2022, the project received almost $500,000 from the Commonwealth Government’s Accelerating Commercialisation fund.

The Inhaled Oxytocin Project is working on developing a novel heat-stable powder formulation of oxytocin that, when inhaled, aims to protect against postpartum haemorrhage (comparable to existing gold standard injection products). Delivering it as an aerosol eliminates the need for cold chain storage or injection delivery. This makes it more accessible and affordable and allows it to be administered in resource-poor settings.

The team is led by Professor Michelle McIntosh, whose early proof-of-concept oxytocin delivery research was recognised in 2011 by the then-US Secretary of State, Hillary Clinton, as having the potential to transform the field of maternal healthcare.

Early development of the project was supported by the McCall MacBain Foundation, the Bill & Melinda Gates Foundation, Grand Challenges Canada, Saving Lives at Birth, Planet Wheeler Foundation and MIPS development partner GlaxoSmithKline. Current collaborators include Johnson & Johnson, the McCall MacBain Foundation and the Victorian state government.

The latest Government grant totals $490,222 and will be used to complete a clinical trial that will facilitate late-stage development and commercialisation of inhaled oxytocin that will allow global access and deliver the life-saving product into the hands of those who need it most.

A guide for academics on navigating a path to commercialisation for nanoneedles

Professor Nicolas Voelcker and Dr Roey Elnathan

Professor Nicolas Voelcker (left) and Dr Roey Elnathan

A paper published in Nature co-authored by MIPS researchers aims to highlight important lessons from the early evolution of start-ups focussing on nanoneedle technology.

Nicolas Voelcker, a professor at MIPS and Scientific Director of the Melbourne Centre for Nanofabrication, and Dr Roey Elnathan, previously a senior research fellow at MIPS who currently holds an adjunct position, have collaborated for many years in the area of nanoneedle technologies.

Titled ‘The start-ups taking nanoneedles into the clinic’, the paper outlines the burgeoning advances and strong commercial activities of nanoneedle technology and discusses how academics can make the most of this exciting opportunity.

According to the article, nanoneedles are “vertical arrays of high-aspect-ratio nanomaterials”. They have emerged as a simple, controllable and powerful tool to efficiently access cells, with the transformative potential to become competitive solutions for sensing, as well as a path to transforming gene and cell therapies.

The authors argue that many more start-ups are needed to make nanoneedle technology mainstream. However, to make that happen, emerging researchers must be supported to develop industry-relevant skills. This includes training on how to engage with and create a culture of entrepreneurship and investment and advanced manufacturing practice.

“Around the world, university-bred entrepreneurs are spurring scientific and technological innovations in the nanoneedle space, which is now leading to practical and exciting applications in sensing, therapeutic and diagnostic technologies,” said Dr Elnathan.

“However, we believe that more resources should be devoted to educating our emerging entrepreneurs that teaches them how to embrace research commercialisation from the conceptual stages right through to translation and, ultimately, end-users.”