The sellside was quick today to shrug off a delay to Iovance’s lead project, lifileucel, in metastatic melanoma. But the fact the company cannot agree with the FDA on the potency assays needed for its BLA submission highlights yet another potential stumbling block for the real-world use of tumour-infiltrating lymphocytes (TILs). As Iovance’s TILs are simply extracted from a person’s tumour and expanded before being reinfused, therapy will vary from patient to patient – and the active targets are also likely to differ, Stifel analysts noted, unlike with CAR-T, for example. This will make standardising TIL therapy tricky, and the FDA is obviously keen to cut down on variability as much as possible. Iovance seems confident that it can “refine” its potency assay data and file lifileucel in 2021; it had previously expected to submit by the end of this year. Both Stifel and Mizuho analysts remain hopeful of approval in 2022, based on the data released so far. But the potency issue comes on top of questions around whether TILs are patentable or economically viable, and Iovance stock opened down 12% this morning. Other TIL players take note.
|Selected TIL approaches in development|
|Company||Lead TIL project||Status|
|Iovance Biotherapeutics||Lifileucel||Melanoma filing delayed until 2021|
|Achilles Therapeutics||ATL001||Ph1/2 in melanoma (NCT03997474) & NSCLC (NCT04032847)|
|Tilt Biotherapeutics||TILT-123 (oncolytic adenovirus) + TILs||Ph1, NCT04217473|
|Genocea Biosciences||GEN-011||IND filed in Sept 2020|
Source: EvaluatePharma, clinicaltrials.gov.
This story has been updated to clarify that TILT-123 is an oncolytic adenovirus, and to add Genocea's GEN-011.