Iovance will use CDMO WuXi Apptec for initial commercial supply of lifileucel, but a Philadelphia plant under-construction looks to bring its tumor infiltrating lymphocyte (TIL) cell therapies inhouse.
Iovance announced in June last year that it is constructing a 136,000 square-foot facility in Philadelphia, Pennsylvania to manufacture its pipeline of autologous cell therapy candidates.
At the time, the plant was expected to cost Iovance $75 million (€69 million) over three years “for equipment and construction of the manufacturing suites,” but speaking this week on its Q4 financial results call the firm has now placed this figure at $85 million.
Iovance’s lead candidate lifileucel in Phase II trials for metastatic melanoma.
“For launch, the initial commercial supply will come from our CMO [contract manufacturing organization] partner WuXi AppTec’ Philadelphia facility as we continue to build our internal Iovance manufacturing capability,” CEO Maria Fardis told stakeholders.
Iovance’s new facility “is expected to be operational by year-end 2020-2021 to support commercial supply in 2022,” with the capacity expected to meet demand for thousands of patients, she added.
WuXi manufactures TIL product for Iovance at its Commerce Center 3 facility, a 55,000-square-foot late-phase and commercial manufacturing facility within WuXi Advanced Therapies’ cell and gene therapy site in the Philadelphia Navy Yard.
Iovance’s second generation (Gen 2) TIL production process is based on a 22-day process involving the isolation of TIL cells from a patient’s own tumor and then the expansion of them by stimulating them ex vivo. At the beginning of the process, the cells are fragmented in a minimalized cell culture system for the first 11 days, before rapid expansion begins. On day 16 the cells are split into multiple flasks, and day 22 they are harvested.
“Currently, our commercial plan is very much locked and loaded for Gen 2,” said Fardis. “The facility is very much designed around Gen 2. Of course, they can support other manufacturing properties, should there be a need for them. But right now, we very much are planning on our commercialization for Gen 2 process.”
Iovance has already started building out its team in Philadelphia as “the building itself requires a number of staff who are familiar with the process,” she added. “We already have a team that is slowly ramping up to what is going to be needed by the time the commercial activities roll out.”