Iovance delayed again

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 &

The table in this story has been updated to remove Genocea's GEN-011.

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