The agreement follows the US Food and Drug Administration (FDA) lifting the clinical hold on the Phase 1/2 clinical trial of VX-880, a T1D therapy developed by Vertex


ViaCyte develops potential cell-based therapies for T1D. (Credit: CDC on Unsplash)

US-based biopharmaceutical company Vertex Pharmaceuticals has signed a definitive agreement to acquire regenerative medicine company ViaCyte for a total of $320m in cash.

The agreement follows the US Food and Drug Administration (FDA) lifting the clinical hold on the Phase 1/2 clinical trial of Vertex’s T1D therapy VX-880.

VX-880 is an experimental stem cell-derived, fully differentiated insulin-producing islet cell therapy to treat impaired hypoglycaemic awareness and severe hypoglycaemia in people with type 1 diabetes (T1D).

The drug works by potentially restoring the body’s ability to regulate glucose levels by repairing pancreatic islet cells and enabling glucose-responsive insulin production.

Similar to its VX-880, ViaCyte also develops novel stem cell-derived cell replacement therapies for a potential treatment for T1D.

The acquisition is expected to be completed later this year, subject to certain customary closing conditions, including the waiting period under the HSR Act, among others.

Vertex chief executive officer and president Reshma Kewalramani said: “The acquisition of ViaCyte will accelerate our goal of transforming, if not curing T1D by expanding our capabilities and bringing additional tools, technologies and assets to our current stem cell-based programmes.”

ViaCyte develops a gene-edited, immune-evasive investigational islet cell replacement therapy for diabetes that could potentially eliminate the need for exogenous insulin.

The company was supported by JDRF and the California Institute of Regenerative Medicine in its research and has entered a collaborative partnership with CRISPR Therapeutics.

With the acquisition of ViaCyte, Vertex will benefit from complementary assets, capabilities and technologies, and is enabled to advance its ongoing T1D programmes.

It will add new human stem cell lines, intellectual property related to stem cell differentiation and good manufacturing practices (GMP) facilities for cell-based therapies.

In addition, the acquisition enables Vertex to access novel hypoimmune stem cell assets, through ViaCyte’s collaboration with CRISPR Therapeutics.

ViaCyte president and chief executive officer Michael Yang said: “This acquisition will allow Vertex to deploy ViaCyte’s tools, technologies and assets toward the development of Vertex’s multiple cell replacement therapy approaches designed to reduce the burden of millions of people living with T1D worldwide.”