IOV-5001 / Iovance Biotherap - LARVOL DELTA

A Study of IOV-5001 in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Not yet recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P1/2 trial • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • BRCA • BRCA2 • HER-2 • MSI • PD-L1 • ROS1

Iovance Biotherapeutics Announces Clearance of Investigational New Drug (IND) Application for IL-12 Tethered TIL Therapy IOV-5001 (The Globe and Mail) - "The Phase 1/2 trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually....'We look forward to beginning patient enrollment in the second half of 2026.'"

IND • New P1/2 trial • Colorectal Cancer • Hormone Receptor Breast Cancer • Triple Negative Breast Cancer

Next Generation Pipeline (The Manila Times) - "An Investigational New Drug (IND) application was submitted to FDA for a Phase 1/2 basket trial of IOV-5001, a second-generation IL-12 tethered TIL therapy, to begin enrolling in 2H 2026. Cohorts include advanced colorectal cancer, triple negative and estrogen receptor low breast cancers, and other highly prevalent solid tumors...A Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC....A Phase 1 safety cohort using IOV-3001 is advancing through multiple dose levels in the Phase 1/2 trial of our second-generation, modified IL-2 analog for the TIL treatment regimen."

New P1/2 trial • Trial status • Colorectal Cancer • Hormone Receptor Breast Cancer • Melanoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Pipeline Updates (The Manila Times) - "New Data Across Several Pipeline Programs Anticipated Throughout 2026...The Phase 3 TILVANCE-301 trial of lifileucel and pembrolizumab in frontline advanced melanoma made significant progress, with enrollment accelerating across a broad and expanding global footprint...Two of Iovance’s Phase 2 trials, IOV-END-201 and IOV-MEL-202, are investigating lifileucel in previously treated patients with advanced endometrial cancer and melanoma, respectively...A Phase 1/2 trial is investigating IOV-4001...A Phase 1/2 trial is investigating IOV-3001...An Investigational New Drug (IND) submission is planned in the first half of 2026 to begin clinical development of IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in a Phase 1/2 basket trial."

Clinical data • IND • New P1/2 trial • P2 data • Trial status • Endometrial Cancer • Melanoma • Non Small Cell Lung Cancer • Ocular 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

Enhanced tumor function with IOV-5001, an autologous tumor-infiltrating lymphocytes (TIL) engineered with inducible membrane-tethered IL-12 (SITC-SSC 2026) - No abstract available

Tumor-infiltrating lymphocyte • Oncology • IL12A

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

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