About Regeneus

Regeneus is an Australian biotechnology company aiming to improve the quality of life of patients suffering from pain.

We develop regenerative medicine products that interrupt the inflammatory cascade that leads to pain in the first place. Worldwide, there are hundreds of millions of patients suffering from short-term and chronic pain. Regeneus listed on the Australian Securities Exchange (ASX) in September 2013 under the ticker code ‘RGS’.

Investment highlight

Regeneus is focused on the US$69 billion global pain market, starting with commercialising Progenza™ for osteoarthritis in Japan.

Watch the above video where new Regeneus (ASX:RGS) CEO Karolis Rosickas announces the release of the Company's Half Year Results for H1 FY21.

Latest news & insights

See below for the latest updates on the Company's activity.

Q&A with Chrys Maoudis, Research Scientist at Regeneus

Q. What is your background and experience in the regenerative medicine and stem cell space? How did this lead you to Regeneus?

A. I have always had a passion to play a part in improving people’s health and this passion led me to undertaking a Bachelor’s degree of Medical Science at The University of Technology, Sydney (UTS).

It was actually Regeneus that led me into the stem cell and regenerative medicine space – not the other way around.

I started with Regeneus over seven years ago as an intern student while I underwent my Bachelor’s degree. From this internship and while I was still at university, I was hired at Regeneus as a Laboratory Technician. Once I completed my Bachelor’s degree, my role at Regeneus developed into a full time Research Scientist position. In this role I have had the opportunity to work on Research and Development (R&D) projects for both Progenza™ and Sygenus as well as working on exciting projects with external collaborators from both academia and industry partnerships.

Q. Tell us about your role as a Research Scientist at Regeneus?

A. My role as a Research Scientist is quite dynamic where my day-to-day duties can vary greatly from R&D projects to product manufacture, and from inventory and laboratory management roles to neuropathic pain preclinical trial designs.

I have been heavily involved in the Regeneus pain project after Regeneus received an ARC Linkage Grant with our collaborators from the University of New South Wales (UNSW) and the University of Adelaide. Our focus on pain under this grant has led to the generation of preclinical datasets for both our Progenza™ and Sygenus platforms. I worked closely with world leading pain expert Prof. Mark Hutchinson from the University of Adelaide and Regeneus Chief Scientific Officer Prof. Graham Vesey to plan, design, and manufacture a range of products to run in rodent models of acute and neuropathic pain. Those preclinical trials produced positive results where we saw reversal of acute and neuropathic pain.

Regeneus also recently received a Department of Defence (DoD) grant to investigate Sygenus for potential treatment of combat casualties. As part of this funding, I am involved in the product development, production and analysis of Sygenus to be assessed in models of acute pain at the University of Adelaide.

Currently, most of my time is spent in the laboratory, where myself and my colleagues are responsible for designing, conducting, and reporting on experimental work related to Regeneus’ research project activities, and Phase II development of our keystone product Progenza™ for knee osteoarthritis. This work involves culturing, vialing, and testing Progenza™, plus further development to Phase II trials. Further to my research role, I also coordinate Regeneus’ laboratory management and inventory, ensuring we have all the equipment and reagents needed to conduct R&D and manufacture product for preclinical trials and Phase II product development.

Q. What is your focus for the next 12 months?

A. My focus for the next 12 months is to support the product development of our Progenza™ and Sygenus technology platforms.

Working with our R&D team and collaborating with our contract research organisations or CROs, I will focus on product development for the Sygenus product platform and the production and design of preclinical datasets for new indications including neuropathic and acute pain. This work stems from our previous work on the MSCs and their secretome and their ability to modulate pain.

Further to this, I will be working on Phase II product development for Progenza™ and working with our contract manufacturer to assist in ensuring that the best product will be made for our Phase II trials.

Q. What do you believe is next for regenerative medicine and what role do you think Regeneus can play in advancing the sector?

A. The regenerative medicine space is one of dynamic change and development, needing products that are not just unimodal but are able to have multiple mechanisms to address symptoms and, crucially, have a disease modifying effect on complex diseases. Something that always sticks in my mind is that “where we have complex pharmacology and disease progression, complex treatments are needed”.

This is where I believe the next stage in regenerative medicine is, where regulators can collaborate more closely with the sector to allow proven, safe and efficacious products an easier pathway to market.

Regeneus is at the cutting edge of this type of treatment. Our Progenza™ and Sygenus platforms can provide the complexity of treatment to target complex diseases, such as osteoarthritis and neuropathic pain, in a disease modifying way. Single molecule drugs or treatments have not been shown to achieve the same effect, as they typically only address the symptoms, not the underlying cause of the disease.

Q. What are you most excited about for Regeneus’ technology and as a company? How does your role help support this?

A. Regeneus is at the forefront of the development of treatments for complex diseases and we are currently undergoing a time of growth and product development that has the potential to one day improve patient care and modify disease.

The ability to be behind a company making such achievements in the regenerative medicine space, while seeing the potential of our products in preclinical trials with the vision for them to ultimately be administered in a person to cure disease, is most exciting.

Q&A with Brian Saputro, R&D Scientist at Regeneus

Q. How did you develop your interest in the regenerative medicine and stem cell space?

A. Born and raised in Indonesia, where the curriculum was quite focused on science, I have always been intrigued in life sciences and everything related.

I came to Australia for university in 2008 and completed a Bachelor of Biotechnology at the University of New South Wales (UNSW). While there was a myriad of biotech fields covered during my study, my interest piqued at stem cells. Regeneus’ CEO at the time, John Martin, also delivered a lecture to my cohort focused on Biotech in Business, which is what initially drew me to Regeneus and its work in the regenerative medicine field.

I then completed my honours thesis at UNSW with Regeneus, focusing on blood-based assays to increase the detection sensitivity of the stem cell secretome.

Following my thesis, I started with Regeneus in the Human Health team for two years, before transferring to the R&D team where I now support the development of our Progenza™ product in the lead up to Phase II trials.

Q. As Regeneus progresses toward Phase II trials, what role do you play in optimizing Regeneus’ lead technology platform Progenza™?

A. Optimising Regeneus’ technology to solve problems for human health is incredibly fulfilling. It has always felt like scratching a brain itch for me.

A total of 28 combinations of various types of , such as basal media and growth supplements, were thrown into the mix with our donor MSCs, with the aim of finding the ideal combination that would optimise growth, while maintaining optimal viability and functionality.

Since then, I’ve been mainly focused on further optimising the culturing process for Progenza™ Phase II trials, as well as performing and optimising the battery of MSC potency assays that Regeneus performs to ensure the Progenza™ product is of the highest quality. This includes cell surface markers analysis, multiplex platform cytokine analysis, T Cell Assays and Priming Assays. Since the completion of our Phase I Clinical Trial manufacture, we’ve successfully obtained new cell lines from different donors, and these potency assays became crucial for assessing each cell line.

We utilise potency assays to assess the qualities of each batch of cells and conduct further assessments to ensure the cells are optimised to deliver the best effect for patients. This work is crucial to predicting the scalability of our donor cells which informs our process for manufacturing for preclinical and clinical trials.

Q. You also support the development of Regeneus’ second platform technology Sygenus. What does this involve?

A. For our second platform technology, Sygenus, I have been involved in developing a 3D bioreactor system, which has been quite intriguing to optimise.

MSCs require surface attachment to metabolise and grow. In planar culture, MSCs can only grow within the limits of the flask surface area before the cells produced become too dense. Our goal with 3D culture development is to provide a larger growth surface area, that can be scaled easily without a significant increase in labour and cost of goods. Bioreactors also allow for increased in-process testing and control of the culture environment to ensure we produce a consistent MSC secretome for every Sygenus batch and to maintain the strong anti-inflammatory activity of the secretome. We are now excited to explore this manufacturing technology further with our Department of Defence grant work to investigate Sygenus for potential treatment of battlefield combat wounds.

Q. What do you believe is next for regenerative medicine and what role can Regeneus play in advancing the sector?

A. Within the regenerative medicine sector, the understanding of the mechanism of action of MSCs has changed over the past decade. Initially, it was understood that the therapeutic effect of MSCs came from the cells themselves. Then, it was realised that it is the bioactive secretome, that the cells produce, that have the true effect. Now, more work is being done to understand the role of the bioactive secretome and the components within them.

Regeneus was one of the first in the industry to identify the role of the secretome in modulating the immune system, contributing to addressing patient symptoms, but also to the disease modifying effects. Regeneus has built a strong patent portfolio around the combination of the MSCs and the bioactive MSC secretome to ensure we can utilise this science to address key conditions, such as pain and inflammation, where other companies cannot.

Disease modifying treatments are not currently available in the market for knee osteoarthritis and many patients suffering from significant pain are particularly dissatisfied with the current treatments available. For example, of the around 1.5 billion people globally who suffer from pain[1], 50 per cent of patients report inadequate relief from existing therapies[2]. This makes the work we do at Regeneus particularly exciting, as we may be the first to fill the gap in these markets and address the unmet needs for these patients.

Q. What are you most excited about for Regeneus’ technology and as a company?

A. At Regeneus, our goal has always been to find solutions that address unmet medical needs for patients of highly prevalent conditions, such as osteoarthritis and pain. Our current pipeline for Progenza™ and Sygenus means we have the potential to make a real difference.

 

[1] Chronic Pain and Health of Populations. Boston University, 2017

[2] Chronic Pain and Health of Populations. Boston University, 2017

 

 

 

 

 

 

 

 

 

 

 

Q&A with Dr. Veronica Iatarola Antas, Research Scientist and Project Lead at Regeneus

Q. Tell us about your role as a Research Scientist and Project Lead at Regeneus?

A. My role is extremely diverse and has evolved over my time at Regeneus. Initially, I was responsible for optimising our product manufacturing processes, including manufacturing products for our preclinical and clinical trials. For example, I provided the data to support preclinical studies that evaluated Progenza™ for osteoarthritis in rabbits and pain in rats.

Currently, my focus is on conducting assurance reviews of data and documentation relating to our technologies before it is transferred to prospective contract manufacturing organizations (CMOs) we may work with. For example, I am currently working on this in preparation for the manufacturing of our Progenza™ product for our Phase II clinical trials, as we seek licence and collaboration partners in the US. I also participate in R&D projects led by our Head of R&D, Dr. Charlotte Morgan and R&D Manager, Flyn McKinnirey, in addition to performing Quality Assurance and process improvement duties at Regeneus.

Q. What is your background and experience in the regenerative medicine and stem cell space? How did this lead you to Regeneus?

A. I have always been fascinated by Medical Science, especially the regenerative medicine and stem cell fields. I started my career as a Pharmacist, followed by post-graduate studies in Assisted Reproductive Technologies, Higher Education and Nutrition. My passion for research led me to complete my PhD on molecular mechanisms that regulate hematopoietic stem cell development at the University of Sydney.

During my PhD I published multiple articles on stem cells, and I also lectured in Medicine at University of Sydney. After my PhD, I worked as the Manager of the NSW Stem Cell Network where I got a glimpse of different companies and initiatives in the stem cell industry within NSW, which gave me further insight and passion for the industry. This is what led me to Regeneus.

Q. What is your focus for the next 12 months?

A. My focus for the next 12 months is to work closely and efficiently with both the Regeneus team and our CMO’s to ensure that we get Progenza™ ready for Phase II clinical trials in Japan and the US. Technology transfer between Regeneus and CMOs is well underway, together with our Good Manufacturing Practice (GMP) development, which I am helping manage. This involves applying quality processes to every manufacturing stage to ensure that the final product consistently meets specifications and safety requirements.

Once Progenza™ GMP manufacturing is concluded, Phase II clinical trials will take place. Phase II clinical trials are very important, as the data captured will allow Regeneus to move forward on our commercialisation pathway and ultimately obtain conditional market approval in Japan.

The opportunity for Progenza™ and Regeneus to deliver a truly unique and effective treatment option to patients of osteoarthritis is very promising, and over the next 12 months I am committed to ensuring these prospects turn into reality.

Q. What do you believe is next for regenerative medicine and what role do you think Regeneus can play in advancing the sector?

A. The regenerative medicine sector has made rapid progress in the past few years and there has been a dramatic increase in the number of products that are either under clinical trials or already in the market.

Regeneus has two competitive, proprietary platforms (Progenza™ and Sygenus) that target pain and inflammation, while promoting tissue repair. The disease modifying properties of these two products, due to our patented inclusion of Mesenchymal Signalling Cells (MSCs) and their bioactive molecules (‘secretome’), make them superior to most ‘traditional’ drugs, which tend to be restricted to symptomatic relief and/or are associated with serious side effects.

As Regeneus is the only regenerative medicine company to have the patents to develop this innovative science, I believe our two platforms place Regeneus at the forefront of the regenerative medicine market and I hope will see us deliver life changing therapies to patients globally.

Q. What are you most excited about for Regeneus and the impact it can make?

A. I am thrilled to be part of Regeneus at a time of rapid progress and imminent break-through achievements. Regeneus is a company that truly values innovation, research and commercialisation of novel products and technologies, and I strongly relate to these principles.

Progenza™ and Sygenus have great therapeutic potential which can positively impact the quality of life of patients suffering from osteoarthritis and other inflammatory conditions. I am most excited to see the progression of our products to clinical trials and ultimately to the market, as I have witnessed in our preclinical trials their potential to be life-changing and provide a multitude of therapeutic benefits to patients.

I am proud of the work I do at Regeneus and of the hard-working team that I am a part of. It is truly rewarding to know that one day what we do may contribute to providing pain-free life to many people worldwide.

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