After generating ASCO fervor, Iovance unveils plans to build $75M cell therapy manufacturing plant
After causing a stir weeks ago with its ASCO abstract that hinted at the potential supremacy of its cell therapy for difficult-to-treat advanced cervical cancer, Iovance on Wednesday said it would invest millions in constructing a 136,000 square foot facility in Philadelphia.
Iovance expects to shell out some $75 million over three years for equipment and construction, which is expected to kick off in the coming weeks. Once completed, the facility will manufacture the company’s tumor infiltrating lymphocyte (TIL) products for several thousands of patients annually, and create several hundred jobs at full capacity.
“Building our own internal production capabilities will help us reduce the cost of operations which is necessary for offering broad access to TIL therapy…Our intention is to continue collaborating with our existing contract manufacturing organizations while we complete the facility in 2021,” Iovance chief Maria Fardis said in a statement.
Iovance’s experimental TIL therapies are derived from T lymphocytes — immune cells that are wired to penetrate tumors and snuff out cancer cells. Naturally, there aren’t enough T lymphocytes to vanquish cancer, so Iovance extricates the cells from the body, enhances their growth in the lab, and reinfuses them back into the patient.
The process is similar to that of existing personalized CAR-T cell therapies: Novartis’ $NVS Kymriah and Gilead’s $GILD Yescarta. Kymriah sales have suffered due to manufacturing issues. In the first quarter, the drug — billed as a blockbuster — generated a paltry $45 million. However, Novartis is doing its best to shore up manufacturing, having bought cell and gene therapy manufacturer CellforCure.
Fardis, in an interview with FierceBiotech last year, suggested Iovance had refined its manufacturing process down to 22 days and established a technique to freeze the cells to make them easier to handle.
On May 15th, Iovance’s shares $IOVA rocketed up after the California-based drug developer posted intriguing data on its TIL regimen, LN-145. Data showed the drug induced an objective response rate (ORR) of 44% and a disease control rate of 89% on the first 27 patients in the planned 59-patient study. In contrast, Merck’s $MRK checkpoint inhibitor Keytruda was approved for second-line cervical cancer with a 14% ORR.
The company’s lead experimental TIL, lifileucel, is currently being tested in a pivotal melanoma study. Other therapies in its pipeline are being investigated for use in head and neck and non-small cell lung cancer.
Bluebird Bio $BLUE in March unveiled its $80 million facility in Durham, North Carolina, which will make its gene-therapy for beta thalassemia, Zynteglo. Meanwhile, Novartis is also building $55 million manufacturing plant in the region to produce its newly-approved spinal muscular atrophy gene therapy Zolgensma — that costs an eye-popping $2.1 million — spread across a five-year installment plan.
Image: Iovance Biotherapeutics