Last October Iovance pushed back the filing of its lead project, lifileucel, in metastatic melanoma from 2020 to 2021. Now the company has been delayed again, and does not expect to be able to submit the project to the FDA until the first half of next year. Standardising the autologous tumour-infiltrating lymphocyte therapy still appears to be the problem, with the FDA apparently unsatisfied with the company’s latest potency assay data. Work on these assays will continue, and lifileucel’s launch is now unlikely until 2023, Stifel analysts noted. Iovance is also trialling the project in cervical cancer, where the pivotal C-145-04 study is enrolling. Iovance’s latest delay might allow some of its rivals to catch up: since Evaluate Vantage last carried out this analysis several more TIL players have emerged, including Instil Bio, which recently pulled off a $368m IPO. Instil is developing both unmodified and genetically engineered TILs; Intima Bioscience and KSQ Therapeutics are working on Crispr-edited TILs. Iovance stock slipped 11% in early trade, with the company providing a cautionary tale to the rest of the space, by highlighting that, for cell therapies, generating clinical data is just part of the equation.
|Selected TIL approaches in development|
|Company||Lead TIL project||Status||Note|
|Iovance Biotherapeutics||Lifileucel||Melanoma filing delayed until H1 2022; cervical cancer ph2 ongoing||First cut of Keytruda combo data from cohort A, checkpoint-inhibitor naive melanoma, at Asco|
|Immatics||IMA101/Actolog||Ph1 in solid tumours||Data presented at SITC 2020; company appears to have deprioritised|
|Achilles Therapeutics||ATL001||Ph1/2 in NSCLC (Chiron) & melanoma (Thetis)||Chiron interim data due H2 2021|
|Intima Bioscience||Crispr-engineered TILs||Ph1/2 in GI cancers||Crispr edited to inhibit CISH|
|Instil Bio||ITIL-168||Ph2 in melanoma to start H2 2021 (compassionate use data proxy for ph1)||Unmodified TILs|
|Nurix Therapeutics||DETIL-0255||Ph1 to start H2 2021||Uses ex vivo CBL-B inhibition|
|KSQ Therapeutics||KSQ-001||IND-enabling studies ongoing||Crispr edited to inhibit CT-1|
|Obsidian Therapeutics||cytoTIL15||IND-enabling studies ongoing||Engineered with membrane-bound IL15|
|Adaptimmune||TIL-IL7||Preclinical||TILs co-expressing IL-7; collaboration with CCIT, Denmark|
|Source: Evaluate Pharma & clinicaltrials.gov.|
The table in this story has been updated to remove Genocea's GEN-011.