Lonza and Vertex to partner to manufacture diabetes cell therapies

The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.

Lonza and Vertex to partner to manufacture diabetes cell therapies

Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US.

Operated by Lonza, the 130,000 square foot facility is anticipated to create up to 300 new jobs at peak capacity.

Diabetes cell therapy manufacture 

In Vertex’s first clinical programme, VX-880, recently released data showed all six patients treated with VX-880 engrafted islet cells, produced endogenous insulin (C-peptide). Additionally, it indicated patients had improved glycaemic control, while reducing or eliminating insulin use. Participants with greater than 90 days of follow-up had elimination of severe hypoglycaemic events in the evaluation period. 

VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy being evaluated for Type 1 diabetes patients with impaired hypoglycaemic awareness and severe hypoglycaemia.

The treatment has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including glucose responsive insulin production. It is delivered by an infusion into the hepatic portal vein and requires chronic immunosuppressive therapy to protect the islet cells from immune rejection.

[Investigational allogeneic stem cell therapy VX-264 for Type 1 diabetes] eliminates the need for immunosuppression”

Alternatively, VX-264, which has the same allogeneic human stem cell-derived islets as in VX-880, is being studied in a Phase I//II clinical trial. In VX-264, the cells are encapsulated in a channel array device designed to shield the cells from the body’s immune system, according to Vertex. This eliminates the need for immunosuppression. The stem cell therapy is designed to be surgically implanted.

Vertex’s cell therapy portfolio and “results from the Phase I/II VX-880 programme represent a scientific breakthrough that offers the potential to transform the treatment of Type 1 diabetes,” stated Dr Reshma Kewalramani, Chief Executive Officer and President of Vertex Pharmaceuticals.

To support diabetes cell therapy production, construction of the US manufacturing facility is scheduled to begin later this year.