Sep. 9 at 10:19 AM
$LCTX With today's PR Culley seems to be throwing down the gauntlet at
$VRTX Vertex's Viacyte and saying:
We think we will be able to manufacture pancreatic islet cells for type 1 diabetes at scale in a GMP-compliant manner - and you can't.
For context, Vertex leads in the T1DM islet cell replacement space with an ongoing pivotal Ph3 trial in n=50 Pxs (yes - you can run pivotal trials with a sample size of 50 when your treatment's efficacy is transformative...reminiscent of OpRegen). Thus far their data in n=12 Pxs is looking like a "functional cure" for T1DM (ignoring immunosuppression). Vertex is also to my knowledge the largest pure biotech by marketcap at
$101B.
This is a bold proclamation from Culley - let's see how it plays out...
https://news.vrtx.com/news-releases/news-release-details/vertex-presents-positive-data-zimislecel-type-1-diabetes