Vertex Pharmaceuticals Inc. (Vertex) and Lonza announced a strategic collaboration to support the manufacture of Vertex’s investigational stem cell-derived, fully differentiated insulin-producing islet cell therapy for individuals with Type 1 Diabetes (T1D). Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated facility in Portsmouth, New Hampshire. Vertex’s product portfolio for T1D, at present, consists of the VX-880, VX-264 platform and its hypoimmune program.
“Establishing this strategic partnership with Lonza, a world-class manufacturing organization, is a critical milestone in this journey and underscores our long-term commitment to patients with T1D,” said Reshma Kewalramani, M.D., CEO and President of Vertex.
“Lonza has a strong history and established reputation for applying cutting-edge development and manufacturing expertise to enable the progression of exceptional scientific innovations like those developed by Vertex,” said Pierre-Alain Ruffieux, CEO of Lonza.
At the American Diabetes Association conference in San Diego, new data revealed that all six patients treated with VX-880 engrafted islet cells produced endogenous insulin (C-peptide) with improved glycemic control and reduced or eliminated insulin use. Patients with greater than 90 days of follow-up had elimination of severe hypoglycemic events within the evaluation period.
“Vertex’s allogeneic, fully differentiated, insulin-producing islet cells and the results from the Phase I/II VX-880 program represent a scientific breakthrough that offers the potential to transform the treatment of T1D,” stated Kewalramani.
VX-264, studied in Phase I/II clinical trial, utilizes the same fully differentiated insulin-producing islet cells as VX-880. In VX-264, the cells are encapsulated in a proprietary device designed to shield the cells from the body’s immune system, as a result removing the need for immunosuppression.
“Vertex has made impressive progress with its T1D cell therapy program, and we are proud to be the company’s partner of choice in supporting its ambition to transform the treatment landscape for this disease,” praised Ruffieux.
The new facility will be operated by Lonza, spanning more than 130,000 square feet with the potential to create up to 300 new jobs. The development and commercialization of Vertex’s potentially life-changing therapies are expected to be accelerated by Lonza’s scientific, regulatory and manufacturing expertise. The facility will complement Lonza’s global cell and gene technologies manufacturing network, which supports customers in developing, de-risking, commercializing and scaling their emerging therapies.
Xavier De Mollerat Du Jeu, Senior Director R&D at Thermo Fisher Scientific is accompanied by Gianluca Pettiti, Executive Vice President and President, Life Sciences Group at Thermo Fisher Scientific and Fred Parietti, Co-Founder and CEO at Multiply Labs for this Workshop at Advanced Therapies Week 2024.
Manufacturing capacity, complexity and cost are core constraints that limit commercialization of cell and gene therapies, and ultimately patient access. In this Fireside Chat series, join Georgi Makin, VP of Digital & Editorial at Phacilitate and the Germfree team as we discuss the challenges and opportunities associated with delivering cell therapies in a decentralized manufacturing model.