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Q&A with Dr. Cindy Shu, REDI Fellow

11 November 2021News

After being awarded the MTPConnect REDI Fellowship Grant in August 2020, Postdoctoral Research Fellow from the Kolling Institute and University of Sydney Royal North Shore Hospital, Dr. Cindy Shu is joining Regeneus for a 12-month project focused on readying Progenza™ for Phase II trials in Japan and the U.S.

A Medical Research Future Fund initiative, the grant provides financial support to Australian, international and/or multinational medical technology and pharmaceutical companies to bring the best talent in-house to work on priority research projects.

Dr. Shu is a valued researcher in the MTP sector and using her expertise in osteoarthritis (OA) pathophysiology, animal models and immune cell analysis, will assist Regeneus to evaluate the beneficial effects of Progenza™ as we progress to Phase II trials.

Read on to learn more about the work Dr. Shu will be undertaking with Regeneus over the next 12 months.

Q: As Regeneus progresses toward Phase II trials for Progenza™ in Japan and the US, what role will you play in optimizing the technology?

A: Our group at the Raymond Purves Bone and Joint Research Labs routinely uses a well-established pre-clinical model of OA to investigate changes in inflammation, pain sensitisation, and OA joint pathology. In our work with Progenza™, we are injecting the technology directly into the affected joints as you would with human patients. The resulting data will provide a strong indication of how Progenza™ works in an OA joint. Specifically, we will measure changes in the types of inflammatory cells that are present in the joint synovium, the lymph nodes associated with the OA joint, as well as the blood, so we can determine Progenza™’s effects locally and systemically, and in acute versus chronic OA conditions.

Another major outcome is measurement of pain sensitisation. OA causes chronic crippling pain which worsens over time, so we hope to determine how much Progenza™ can improve and stabilise pain sensitivity. We will of course also look at the long-term effect on the joint pathology itself, including whether and how much Progenza™ would slow down and/or prevent OA progression. With the data generated from this preclinical study we hope to provide supporting information for Progenza™ to progress to the next phases of the clinical trials and approvals.

Q: What are you most looking forward to learning over the next two years working with Regeneus?

A: Fundamental research scientists like myself are often limited to what we do with our research outcomes. Many of us entered this profession looking to contribute (“find a cure”), but we are generally not taught how to translate our research. Regeneus has devised a program to bridge this gap, which will also help me consider which path I want to follow if I should consider a transition from pure research.

Q: What do you find most exciting about Regeneus’ technology?

A: In our research at the Raymond Purves Bone and Joint Research Labs we have found that MSCs work their magic by secreting disease modifying factors into the surrounding tissue of the injection site. It’s great to see that this is the focus for Regeneus as we believe it results in a more direct and controlled method of treatment. I am looking forward to seeing how well this new technology can work and hopefully make a difference to patients’ lives in future.

Q: What is your background in the life sciences space and how did this lead you to Regeneus?

A: I have a Bachelor of Science (Biotechnology) and completed my PhD on a project driven by a biotech industry funding partner whose goal was to increase cellular productivity for pharmaceutical production. Following this, I wanted to do something more focused on discovery and medical research. This led me to join the Raymond Purves Bone and Joint Research Labs in 2008, where I investigated a range of musculoskeletal pathologies, potential therapeutics and their mechanisms of action, including mesenchymal signalling cells (MSCs). A big part of my time was spent completing industry funded projects using our preclinical model of traumatic osteoarthritis, to investigate the efficacy and response to the treatment within a living organism. I’m very fortunate to be under the mentorship and guidance of Professor Christopher Little – a collaborator of Regeneus – who has always driven his research with great vision and passion.

Watch: Regeneus (ASX:RGS) Investor Update – November 2021

5 November 2021News

Regeneus CEO Karolis Rosickas hosted a webinar and Q&A with investors on Thursday 4 November. During the session, Karolis provided an update on the Company's progress with its lead platform technology Progenza™, partnership with the Australian Department of Defence for Sygenus, and ongoing strategy, in addition to answering investor questions.

Download the presentation deck here and watch the webinar below.

Regeneus partners with ASTEM to improve efficiencies in adipose tissue donor selection

5 August 2021News

Regeneus has partnered with the Allogeneic STEM cell manufacturing Programme (ASTEM) to investigate the status of a novel genomic biomarker within their adipose donor banks. This work is being conducted at one of the partner institutes of the ASTEM Programme, the Genome Institute of Singapore, which is a leading Research Institute within the Agency for Science, Technology and Research (A*STAR).

One of the major challenges of cell therapy has been the quality of mesenchymal signalling cells (MSCs) obtained from donors, which are scaled up to produce banks of cells for administration to patients. Screening potential donors using this novel genomic biomarker will aid in identifying the best donors, thus ensuring the cell banks produced from them are of the best quality. As a result, the use of cultured MSCs for therapeutic purposes will be enhanced.

Studies conducted within the ASTEM programme showed that the status of the novel DNA biomarker glutathione S-transferase theta 1 (GSTT1) in bone marrow donor tissue correlates with future scalability and potency of MSCs produced from them. This discovery makes it possible to select the best potential donors from whom cell banks with the best quality cells can be propagated/created. This will have a significant impact on easing one of the major bottlenecks for MSC-based cell therapeutics, i.e., robust MSCs. The discovery is patent protected.

MSCs are the cells used in Regeneus’ leading technology platform Progenza™ and which produce the bioactive secretome used in its second technology platform Sygenus.

While work with the GSTT1 biomarker to determine MSC scalability and potency has only been performed in bone marrow donors to date, the collaboration between Regeneus and ASTEM will investigate the biomarker in donors of adipose tissue.

Understanding the scalability and potency potential of donor tissue before it is extracted will provide a valuable tool for Regeneus to improve the efficiency of its donor selection process, and in turn, the manufacturing of its product pipeline. Identifying the donor tissue which will produce the highest yield of potent MSCs and have the highest potential for scalability will position Regeneus to deliver the most effective treatments to patients to address their unmet medical needs.

Charlotte Morgan, Head of R&D at Regeneus, said: “Regeneus’ collaboration with ASTEM is part of our ongoing commitment to seeking research partners that assist us in building our point of difference.

“Collaborations with leading scientists in the regenerative medicine sector, such as the ASTEM team, help us build on our existing research and development capability to uncover more information about MSCs and their secretome. This activity ensures we have the intel we need to use science to our advantage when developing our products.”

Professor Simon Cool from the Institute of Molecular and Cell Biology (IMCB), who leads the ASTEM programme, said: “ASTEM is excited to collaborate with Regeneus on the expansion of its biomarker development programme. This partnership validates the importance of ASTEM in the cell therapy manufacturing ecosystem in addressing key challenges facing the industry, thus leading to better patient outcomes and anchoring Singapore’s role as a global innovation hub”.

ASTEM’s discovery of the potential of the GSTT1 novel biomarker has been recently published in Stem Cells and further validated in archival MSC samples, using third-party assays by renowned stem cell scientist Professor Moustapha Kassem from the University Hospital of Odense.