IOV-2001 / Iovance Biotherap - LARVOL DELTA

IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov) - P1/2 | N=7 | Completed | Sponsor: Iovance Biotherapeutics, Inc. | N=70 ➔ 7 | Trial completion date: Sep 2025 ➔ Dec 2024 | Trial primary completion date: Sep 2025 ➔ Nov 2024 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov) - P1/2 | N=70 | Active, not recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Sep 2025 | Trial primary completion date: Apr 2024 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • IL2 • TP53

IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Jan 2023 ➔ Jul 2024 | Trial primary completion date: Oct 2022 ➔ Apr 2024

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • IL2 • TP53

Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of Iov-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (ASH 2021) - P1/2 | "Background Bruton tyrosine kinase (BTK) inhibitors (ie, ibrutinib, acalabrutinib) are approved for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and can mediate durable responses in some patients; however, relapses are common, primarily due to acquired mutations in BTK enzyme and/or phospholipase C gamma 2 (Albitar F, et al...Treatment consists of a preparative regimen of lymphodepleting chemotherapy (cyclophosphamide IV 500 mg/m 2 and fludarabine IV 30 mg/m 2 ) for 3 days, followed by 2 days of rest, a single infusion of IOV-2001, and 6 doses of either low-dose (9 MIU SC) or high-dose (600,000 IU/kg IV) interleukin-2 (IL-2; Figure 1)...Patients ages ≥18 years, diagnosed with CLL/SLL with radiographically measurable disease, Eastern Cooperative Oncology Group performance status of 0–1, and meeting prior therapy criteria according to Table 2 are eligible for inclusion. Four US sites are currently active and enrolling..."

Clinical • IO biomarker • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • IFNG • IL2 • PLCG2

Iovance Biotherapeutics to Present at Upcoming Conferences (GlobeNewswire) - "Iovance Biotherapeutics, Inc...announced participation in the following conferences in December...The JMP Securities Hematology and Oncology Summit; ESMO Immuno-Oncology Annual Meeting, December 8-11, 2021, Geneva, Switzerland; American Society of Hematology Annual Meeting, December 11-14, Atlanta, Georgia"

Clinical data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

[VIRTUAL] A Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (AACR 2021) - P1/2 | "Background While Bruton’s Tyrosine Kinase (BTK) inhibitors approved for CLL/SLL (ibrutinib, acalabrutinib) can mediate durable responses in some patients, relapses are seen primarily as a result of acquired mutations in BTK enzyme and/or phospholipase C gamma 2...IOV-2001 is a one-time administration cell therapy which involves a preparative regimen of lymphodepleting chemotherapy consisting of cyclophosphamide IV 500 mg/m2 and fludarabine IV 30 mg/m2 for 3 days followed by 2 days of rest...Key eligibility includes diagnosed CLL/SLL patients (18 to 70 years of age) with radiographically measurable disease; and ECOG PS of 0-1, along with specifics per Table 1. The primary objective for Phase 1 is to determine the RP2D, and for Phase 2 is to evaluate the Investigator-assessed efficacy of IOV-2001 at RP2D followed by IL-2."

Clinical • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • IL2 • PLCG2

Iovance Biotherapeutics to Present Updated Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel in Advanced Melanoma at American Association for Cancer Research (AACR) 2021 Annual Meeting (GlobeNewswire) - "Iovance Biotherapeutics...announced that long-term interim data from Cohort 2 in the C-144-01 clinical study (NCT02360579) in advanced melanoma has been accepted as an oral presentation in a Clinical Trials Plenary Session at the upcoming American Association for Cancer Research (AACR) 2021 Annual Meeting...In addition to the oral presentation, three Iovance poster presentations at AACR will highlight the design of clinical trials in progress in solid tumors and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). These posters are intended to educate physicians about study design and will not include clinical data."

Clinical protocol • P2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor

Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma During American Association for Cancer Research (AACR) 2021 Annual Meeting (GlobeNewswire) - “In addition to the oral presentation, three Iovance poster presentations at AACR will highlight the design of clinical trials in progress in solid tumors and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). These posters are intended to educate physicians about study design and will not include clinical data…Abstract Title: A Phase 2, multicenter study of autologous tumor infiltrating lymphocytes (TIL) (LN-144/LN-145/LN-145-S1) in patients with solid tumors (IOV-COM-202)…Abstract Title: A Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (IOV-CLL-01)…Abstract Title: A phase 2 multicenter study of autologous tumor infiltrating lymphocytes (TIL; LN-145) cell therapy in patients with metastatic non-small cell lung cancer (IOV-LUN-202).”

Clinical protocol • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor