What is notable is the inclusion of more preclinical data demonstrating Cymerus MSCs reduction of heterogeneity compared to tissue-derived MSCs. Heterogeneity is a major hurdle to the commercialisation of MSC therapies. As the FDA noted in the ODAC briefing document for Rem-L, in the absence of outstanding results from a well-controlled clinical trial, the therapy at the very least needs to have a mechanism of action (MOA) consistent with what is observed in laboratory testing. If the underlying treatment is not consistent on a batch-to-batch basis, that makes it difficult to achieve. Fortunately, a single blood donation is the foundation for 21 million clinical doses of Cymerus MSCs, greatly improving the probability that the clinical MOA will closely match what is expected.
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