Dive Brief:
- Iovance Biotherapeutics said Wednesday it will build a 136,000-square-foot facility in Philadelphia to produce cancer therapies using its tumor-infiltrating lymphocyte (TIL) technology.
- While construction will take about two years, the California biotech expects to spend some $75 million over three years on the overall project, creating "several hundred" jobs in Philadelphia, according to a statement.
- Iovance received undisclosed financial incentives from the state, city and PIDC, a public-private economic development corporation, for the new site. It also has a letter of intent from PIDC for a five-year option to expand further.
Dive Insight:
Like others in the cell therapy field, Iovance looks to be reducing its reliance on contract manufacturing organizations while it moves closer to market with its leading cancer immunotherapy, lifileucel. The facility will be able to produce enough TIL products to treat several thousand patients a year, Iovance said.
"Building our own internal production capabilities will help us reduce the cost of operations, which is necessary for offering broad access to TIL therapy," Iovance CEO and President Maria Fardis said in the company's statement. In an earlier regulatory filing, Iovance said its own facility would improve margins and allow for "rapid implementation" of advancing science for TIL therapies.
Iovance will keep working with contract manufacturing organizations while construction is underway in Philadelphia's Navy Yard, Fardis said.
The company previously announced agreements with partners including MaSTherCell, PharmaCell, Moffitt and WuXi, which had been identified as the initial commercial manufacturer for lifileucel.
Iovance is aiming to file for U.S. approval of lifileucel in 2020. The TIL therapy is currently in pivotal testing for melanoma and is also being studied in Phase 2 testing along with another of the company's candidates, called LN-145, for melanoma, head and neck cancer, and non-small cell lung cancer.
Proper manufacturing is critical for the complex TIL therapies, which involve the extraction of lymphocytes from patients to isolate and expand the immune cells ex vivo. Cells are then infused back into the patient in hopes of better treating tumors.
Other cell therapy players are expanding, too. Iovance’s plan follows announcements from biotechs, including Allogene Therapeutics, Bluebird Bio and Gilead, for investments in new manufacturing facilities.
Iovance expects to begin construction of the Philadelphia facility in the next few weeks.