IOV-5001 / Iovance Biotherap - LARVOL DELTA

An Investigational New Drug (IND) submission is planned in early 2026 for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in solid tumor cancers with large patient populations and urgent unmet medical. (GlobeNewswire)

IND • Solid Tumor

Next Generation TIL Pipeline (GlobeNewswire) - "PD-1 Inactivated TIL Cell Therapy (IOV-4001): Results are anticipated in the second half of 2025 from the Phase 2 efficacy portion of the IOV-GM1-201 trial in previously treated advanced melanoma...Next Generation Interleukin-2 (IL-2) for TIL Treatment Regimen (IOV-3001): Patient enrollment continues in a Phase 1/2 clinical trial, IOV-IL2-101, to investigate IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen....Next Generation, Cytokine-Tethered TIL Therapy (IOV-5001): IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL cell therapy, in support of an IND in early 2026 for clinical development for multiple indications."

IND • P2 data • Trial status • Melanoma • Oncology

IOV-5001, autologous tumor-infiltrating lymphocytes (TIL) armored with inducible membrane-tethered IL-12, shows enhanced antitumor efficacy with an improved cellular state (AACR 2025) - "IOV-5001 demonstrated superior killing and effector cytokine production compared with unmodified TIL in a tumor antigen-directed TCR killing assay and against autologous tumor, irrespective of aldesleukin support. These findings demonstrate that IOV-5001 with inducible and membrane-tethered IL-12 confers superior antitumor activity compared with unmodified TIL. The enhanced molecular and functional characteristics highlight IOV-5001 as a promising product for enhancing TIL efficacy in solid tumors."

Clinical • IO biomarker • Tumor-infiltrating lymphocyte • Endometrial Cancer • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • IL10 • IL12A • IL5

Iovance Biotherapeutics Announces Participation in Upcoming Scientific Congresses (GlobeNewswire) - "Iovance Biotherapeutics...announced that pre-clinical data for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, will be presented at the 2025 AACR Annual Meeting. In addition, five-year outcomes data from the C-144-01 study of lifileucel monotherapy in patients with advanced melanoma, and a poster on study design for lifileucel in frontline advanced non-small cell lung cancer, will be presented at the 2025 ASCO Annual Meeting."

Clinical protocol • P2 data • Preclinical • Melanoma • Non Small Cell Lung Cancer

Superior anti-tumor activity of IL12-engineered TIL IOV-5001 in simulated tumor microenvironment (SITC 2024) - "Background With the FDA approval of lifileucel as an autologous tumor-infiltrating lymphocyte (TIL) cell immunotherapy for the treatment of advanced melanoma, TIL cell therapy has become a possible modality for the treatment of solid tumor cancers. Conclusions The membrane-tethered, IL12-expressing TIL, IOV-5001, exhibited a favorable phenotype and gene expression profile as well as superior antitumor activity in a simulated tumor microenvironment. IOV-5001 is a candidate for clinical development as a potentially more efficacious next-generation TIL product."

Biomarker • IO biomarker • Tumor microenvironment • Endometrial Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD69 • IFNG • IL12A • NFATC1 • TNFA