Vertex gets FDA nod to start trial of cell therapy VX-264 for type 1 diabetes
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The U.S. Food and Drug Administration (FDA) cleared Vertex Pharmaceuticals (NASDAQ:VRTX) investigational new drug (IND) application seeking to start a trial of cell therapy VX-264 to treat type 1 diabetes (T1D).
The company noted that VX-264 is a stem cell-derived, fully differentiated pancreatic islet cell therapy encapsulated in a Vertex-developed immunoprotective device.

Vertex plans to start a phase 1/2 trial in H1 2023 to evaluate VX-264 in patients with T1D in the U.S.
The phase 1/2 study is already ongoing in Canada.
Vertex said that the VX-264 program does not require using immunosuppression, which may broaden the population reach of the therapy in patients with T1D.
"VX-264 uses the same stem cell-derived pancreatic islet cells as our VX-880 program where weâve already demonstrated proof-of-concept, with the addition of a proprietary immunoprotective device that allows us to eliminate the need for immunosuppression," said Bastiano Sanna, executive vice president and chief of Cell and Genetic Therapies, Vertex.
VRTX +0.63% to $286.99 premarket March 9