In a transcontinental move, a California biotech working on a cell therapy for solid tumors will build its first manufacturing site in Philadelphia.
San Carlos, California-based Iovance Biotherapeutics says it will invest about $75 million over the next several years to build a 136,000 square foot facility in Philadelphia that can scale up for commercial production of its autologous tumor infiltrating lymphocyte (TIL) products. That includes Lifileucel, which is under development for treating metastatic melanoma.
“We are very excited to initiate building our commercial manufacturing facility in Philadelphia. The 22-day Iovance Gen 2 TIL therapy process is robust and scalable, and has led to impressive responses in melanoma, cervical and head and neck indications,” Iovance CEO Maria Fardis said in a statement. “Building our own internal production capabilities will help us reduce the cost of operations which is necessary for offering broad access to TIL therapy.
Construction will get underway within weeks and the facility is slated to be finished in 2021. Until then the biotech will continue to work with contract manufacturers. The plant will employ several hundred workers to manufacture TIL products to treat up to several thousand patients annually.
The complex process, not unlike those used for approved cell therapies Kymriah and Yescarta, involves collecting a tissue sample from a patient, which is sent to a facility where immune cells can be isolated and boosted to billions of cells. They are then cryopreserved and shipped to sites in the U.S. and Europe and infused into the patient. Iovance has its second generation process down to a 22-day turnaround time.
Iovance Biotherapeutics also is looking at TIL therapies for the treatment of patients with locally advanced, recurrent or metastatic cancers including cervical, head and neck and non-small cell lung cancer.
The facility is coming to fruition at the same time that a number of other companies and biotechs are building their own cell or gene therapy production facilities, as are a number of CDMOs.
Novartis is building a new $55 million manufacturing plant in Durham, North Carolina to produce gene therapy Zolgensma which the FDA approved on Friday. The one-time treatment is approved for pediatric patients under 2-years-old with spinal muscular atrophy (SMA) and set a new high watermark for cost with a list price of $2.125 million.
Also in Durham, U.S. biotech Bluebird Bio is putting finishing touches on an $80 million manufacturing site where it will produce Zynteglo, its gene therapy for treating transfusion-dependent β-thalassemia (TDT). Zynteglo has been recommended for approval in Europe.