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

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.