Sumary of Why Iovance Is Up Nearly 11% Today:
- Namely, the odds of an approval of one of its drug prospects seemingly improved after a rival drug developer was granted permission to expand its trials of a similar therapy.
- On Monday, Instil Bio (NASDAQ:TIL) announced the Food and Drug Administration had cleared the company’s request to widen the scope of its current phase 2 trial of ITIL-168. ITIL-168 is a cellular therapy made using tumor-infiltrating lymphocytes, or TILs, from an individual patient’s own tumor tissue.
- While adding melanoma patients with a relapse after other inhibitors have failed is a far cry from a final approval, it does loosely suggest the FDA sees an upside with the drug and approach.
- The clearance has implications for Iovance’s experimental melanoma drug candidate lifileucel, in that this therapy also uses tumor-infiltrating lymphocytes as part of a patient-specific treatment.
- While lifileucel has run into a regulatory headwind — in the form of the FDA’s requests for more information made in October and then again in March — Truist’s analysts believe the FDA’s decision regarding ITIL-168 bodes well for Iovance’s similar drug.
- a modestly widened phase 2 trial isn’t exactly an indication that the drug is a panacea.
- Also bear in mind that the FDA has tendered questions regarding Iovance’s lifileucel in two separate instances now, which may indicate concerns specific to that particular treatment rather than TILs in general.