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Evidence: From October 7 to 9, Glafabra took part in BIO Japan in Yokohama, one of Asia's largest biotech partnering events. The team was there for two kinds of conversations: manufacturing and analytical development partners with experience in autologous lentiviral stem-cell therapy, and Japan-based pharma and academic groups working in lysosomal storage disorders. Both follow from FDA's INTERACT feedback, which pointed to a defined CMC and manufacturing path as the next step for GT-GLA-S03.
Interpretation: Japan has been part of Glafabra's strategy from the start. The clinical data package FDA asked for (alpha-Gal A activity, plasma lyso-Gb3, eGFR slope) is largely the package Japan's PMDA would also want to see, so building relationships in Japan alongside the U.S. program is meant to keep the two moving together rather than one after the other.
Uncertainty: No partnership has been agreed. Any relationship that results would be negotiated and disclosed separately.
Questions about the Japan strategy? Post them below and we'll answer here.
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@Brian Christie @Neva West @ChrisHopkins @Tetsu Yung
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