ISCT 2023 key trends: new generation MSCs  

Paris

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. The ISCT 2023 Annual Meeting took place in Paris, France from May 31 to June 3 2023. DDW’s Megan Thomas heard from attendees about key trends in the sector. First, the importance of cell collections. Next, attendees discuss the trend of allo vs auto. Here, new generation MSCs. In subsequent articles, themes cover future regulatory changes and redefining manufacturing. 

Mesenchymal stem cells (MSCs) were the subject of a session at ISCT, which dealt with the current challenges and future directions of the field. Dalip Sethi, Chief Scientific Affairs at Terumo Blood and Cell Technologies, said: “Identifying an appropriate potency assay for a particular mechanism of action (MOA) for a particular therapeutic indication remains at the top of the mind of key stakeholders. The route of delivery, IV vs local, was also discussed by the panel and audience members. The importance of using freshly cultured cells or re-cultured prior to delivery was highlighted. Although the panel didn’t have enough time to discuss automated systems for culturing of MSC, automated systems such as our company’s Quantum Flex provides an option to developers. Gene-modified MSC were presented as an example of MSC 2.0. Automated systems that will allow culturing and modifying MSC should support the development of the next generation of MSC therapies.” 

Carole Nicco, Chief Scientific Officer of BioSenic, thinks that the remaining limitations with new generation MSCs therapy are largely due to variations in MSC products, their manufacturing practices, the duration and conditions of storage, a lack of understanding on their optimal clinical delivery, their in vivo mechanisms of action, and the insufficient clinical potency assessment. She said: “More fundamental investigations as well as technological improvements need to be done and are ongoing. BioSenic is heavily involved in fundamental mechanistic studies, creating and formulating new ATMPs and conducting clinical trials to demonstrate the benefits for patients. BioSenic is continuing its research projects and aims to combine its two technology platforms, ALLOB and Arsenic-Copper, to create ATMPs to treat autoimmune or immune-related diseases. Autoimmune diseases include at least 80 disorders. Their frequency (prevalence) varies widely from one disease to another, but taken together they affect around 10% of the population of industrialised countries, and this figure has been rising steadily over recent decades.”  

On this topic, Becky Cap, SVP, Business Development, Advanced Therapies at BioBridge Global, notes that embassies have struggled in the development and regulatory space to find a home. She said: “We’ve moved more toward a farm Pharma, or a drug-like model for our approvals. If the flexibility of the MSC does not fit well to the paradigm in our space we have been working with developers to find uniquely suitable applications of MSCs, and with partners approaching the regulatory space with an item toward a model that takes a broader range of factors into consideration to measure potency. This next generation of MSCs will give us more paths to pursue.” 

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