Iovance Receives FDA Allowance For IOV-4001 Study In Two Advanced Cancers

The FDA has signed off Iovance Biotherapeutics Inc's IOVA Investigational New Drug Application (IND) first genetically modified TIL therapy, IOV-4001, for unresectable or metastatic melanoma and stage III or IV non-small-cell lung cancer (NSCLC).
IOV-4001 leverages the gene-editing TALEN technology licensed from Cellectis SA CLLS.
A clinical study of IOV-4001 in patients with metastatic melanoma or stage III or IV NSCLC is expected to begin in 2022.
Read Next: Iovance's Lifileucel Combo Shows Encouraging Response Rates In Advanced Cancers.
A poster highlighting preclinical activity, clinical-scale manufacturing process development, and characterization of IOV-4001 will be presented at American Association for Cancer Research 2022 Annual Meeting.
In the AACR abstract, the anti-tumor activity of IOV-4001 was superior to non-edited TIL and non-edited TIL in combination with anti-PD-1 in a murine model.
Price Action: IOVA shares traded 5.92% higher at $13.25 during premarket trading on the last check Wednesday.