Iovance Receives FDA Allowance For IOV-4001 Study In Two Advanced Cancers
- The FDA has signed off Iovance Biotherapeutics Inc's (NASDAQ: 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 (NASDAQ: 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.
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