IOV-3001 / Novartis, Iovance Biotherap - LARVOL DELTA

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

Pipeline Progress and Anticipated Milestones by Program: Next Generation Programs (GlobeNewswire) - "Clinical results for IOV-4001, a PD-1 inactivated TIL cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026....Dose escalation is continuing for IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen....Advancement into Phase 2 development is expected in 2026."

New P2 trial • P1/2 data • Trial status • Melanoma

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

A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P1/2 trial • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024 (GlobeNewswire) - "Iovance plans to submit an Investigational New Drug application (IND) for a Phase 1/2 clinical trial of IOV-3001, a second-generation, modified interleukin-2 (IL-2) analog, for use in the TIL therapy treatment regimen in the third quarter of 2024; A genetically engineered, inducible, and tethered IL-12 TIL cell therapy, designated IOV-5001, is in IND-enabling studies....An IND submission is planned in 2025."

IND • Oncology

IOV-3001, a modified interleukin-2 fusion protein, for potential use in tumor-infiltrating lymphocyte cell therapy regimens. (ASCO 2024) - "IOV-3001 is a modified dimeric IL-2 fused to palivizumab that has a longer half-life and potentially better safety profile, compared with aldesleukin. IOV-3001 exhibited a similar mechanism of action (MoA) to that of aldesleukin in vitro and has a longer half-life in vivo. PD effects were consistent with the MoA of IL-2. IOV-3001 showed a favorable preclinical safety profile."

Tumor-infiltrating lymphocyte • Hematological Disorders • Oncology • Solid Tumor • CD8 • IL12A • IL2 • IL2RA • IL6 • STAT5

"#AvidBioservices Selected By #IovanceBiotherapeutics to Lead Process Development Through CGMP Manufacturing of Novel #IL2Analog, #IOV3001 $CDMO https://t.co/XUAFW4etyG" (,@1stOncology)

Avid Bioservices Selected By Iovance Biotherapeutics to Lead Process Development Through CGMP Manufacturing of Novel IL-2 Analog, IOV-3001 (GlobeNewswire) - "Avid Bioservices, Inc...today announced that Iovance Biotherapeutic...has selected Avid to provide process development, pilot-batch manufacturing and CGMP manufacturing services to support development of IOV-3001, a novel antibody cytokine engrafted protein."

Licensing / partnership • Oncology

Iovance Biotherapeutics, Inc. announces closing of $603.7 million common stock public offering (GlobeNewswire) - "Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for advanced cervical cancer, to initiate a program directed at registration of Iovance’s tumor infiltrating lymphocyte therapies in non-small cell lung cancer, to continue support of ongoing commercial manufacturing activities, and for the development of Iovance’s IL-2 analog, IOV-3001, and for other general corporate purposes."

Financing • Cervical Cancer • Genito-urinary Cancer • Melanoma • Oncology

Iovance Biotherapeutics, Inc. announces proposed public offering of common stock (GlobeNewswire, Iovance Biotherapeutics Inc) - "Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for advanced cervical cancer, to initiate a program directed at registration of Iovance’s tumor infiltrating lymphocyte therapies in non-small cell lung cancer, to continue support of ongoing commercial manufacturing activities, and for the development of Iovance’s IL-2 analog, IOV-3001, and for other general corporate purposes."

Financing • Cervical Cancer • Gynecologic Cancers • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Newly added product (GlobeNewswire) - Preclinical, Oncology

Pipeline update