With prospects heating up for its experimental cell therapy VX-880 in Type 1 diabetes, Vertex Pharmaceuticals is doubling down on manufacturing, and it’s bringing production juggernaut Lonza along for the ride.
To support production of VX-880 and a second clinical candidate for Type 1 diabetes, VX-264, Vertex and Lonza are teaming up on process development and scale-up for the manufacturing of the drugmaker’s portfolio of stem cell-derived, fully differentiated insulin-producing islet cell therapies.
Further, the companies will co-invest in the build-out of a new facility in Portsmouth, New Hampshire, which will be operated by Lonza and employ up to 300 staffers across 130,000 square feet of real estate.
Construction is slated to kick off later this year, the partners said in a release.
The facility is poised to work in tandem with Lonza’s global cell and gene technologies manufacturing network, with the goal to speed up the development and commercialization of Vertex’s clinical prospects.
Vertex is taking a three-pronged approach in its quest to develop cell therapies against type 1 diabetes. Leading the charge is VX-880, which last week triumphed in a phase 1/2 study presented at the American Diabetes Association’s 83rd Scientific Sessions.
In the early- to mid-stage trial, all six patients treated with VX-880 engrafted islet cells produced endogenous insulin (C-peptide) and demonstrated improved glycemic control.
At the same time, the cell therapy helped patients reduce or cut out insulin use entirely. Additionally, patients with greater than 90 days of follow-up saw the elimination of hypoglycemic events during the span of the evaluation, Vertex said last week.
As for VX-264—which leverages the same fully differentiated insulin-producing islet cells as VX-880—the cells are encapsulated in a novel device designed to shield them from the body’s immune system. The idea behind this delivery method is to eliminate the need for immunosuppression, Vertex has explained.
Finally, Vertex is leveraging its hypoimmune program in which the same cells are edited to be cloaked from the immune system. That program continues to progress in preclinical development, the company said.
Earlier this year, Lonza debuted a new laboratory in Cambridge, Massachusetts, as part of its plan to expand its early development services division in North America. The expanded services aim to help customers pinpoint and address potential problems with drug candidates during the early stages of development and before clinical trials to help cut the risk of failure. The facility is specifically focused on preclinical-stage small and mid-sized biotechs looking to develop biologic drugs.
That project forms part of a greater $935 million global expansion for the Swiss CDMO. In addition to the new Vertex facility, Lonza is also planning a $220 million, 32,292-square-foot facility in Portsmouth that will come equipped with eight 2,000-liter single-use bioreactors. That site, slated to open later this year, will employ about 250 staffers.