LB1901 / Legend Biotech - LARVOL DELTA

[VIRTUAL] Preclinical analysis of an autologous CD4-targeted chimeric antigen receptor T-cell (CAR-T) immunotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). (ASCO 2021) - P1 | "Altogether, the in vitro and in vivo studies showed that LB1901 did not ?mask? the CD4 antigen but exhibited potent anti-tumor activity without off-target effects . A phase 1 study of LB1901 CAR-T in patients with relapsed or refractory PTCL or CTCL is ongoing in the US to assess the safety and tolerability of LB1901 CAR-T (NCT04712864)."

CAR T-Cell Therapy • Preclinical • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • CD8

LB1901: A phase 1, open-label, multicenter, multicohort study of CD4-targeted chimeric antigen receptor T cells (CD4-CAR-T) in relapsed or refractory T-cell lymphoma (TCL) (AACR 2022) - P1 | "Pts may receive optional bridging therapy and receive lymphodepleting chemotherapy with fludarabine 30mg/m2/day and cyclophosphamide 300mg/m2/day (Flu-Cy), for 3 days followed by LB1901. Secondary endpoints include overall response rate; duration of response; CAR-positive T cell counts and CAR transgene level in blood; and presence of anti-CAR antibody response. Exploratory endpoints include preliminary efficacy, pharmacokinetics, and CD4+ T cell counts."

CAR T-Cell Therapy • Clinical • P1 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD19 • CD4 • CD8

Legend Biotech : Announces Termination of its Phase 1 Clinical Trial Under Investigational New Drug (IND) Application for LB1901 - Form 6-K (Market Screener) - "Legend Biotech Corporation ('Legend Biotech') notified the U.S. Food and Drug Administration (FDA) that Legend Biotech has terminated its Phase 1 Clinical Trial under the Investigational New Drug (IND) application for LB1901...for the treatment of adults with relapsed or refractory T-cell lymphoma. Legend Biotech terminated this trial: based on a lack of clinical benefit from a similar Legend Biotech CAR-T product candidate expressing the same CAR protein as LB1901 that was the subject of an investigator-initiated study conducted in China and in order to prioritize other product candidates in Legend Biotech's pipeline."

Trial termination • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Legend Biotech Reports First Quarter 2022 Financial Results and Recent Highlights (Businesswire) - "On May 25, 2022, The FDA lifted its clinical hold of Legend Biotech’s Phase 1 clinical trial of LB1901, the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL)."

FDA event • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

LB1901-TCL-1001: Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Legend Biotech USA Inc | Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Enrollment closed • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • TNFRSF8

Legend Biotech Announces FDA Clinical Hold of its Phase 1 Clinical Trial for LB1901 (Businesswire) - "Legend Biotech Corporation...announced that on Friday, February 11, 2022, the company was informed by the U.S Food and Drug Administration (FDA) via e-mail communication that its Phase 1 clinical trial for LB1901 has been placed on clinical hold. LB1901 is the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL). The FDA indicated they will provide an official clinical hold letter to Legend Biotech by March 11, 2022."

Trial suspension • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

LB1901-TCL-1001: Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Legend Biotech USA Inc; Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Clinical • Enrollment open • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • TNFRSF8

Legend Biotech Begins Phase 1 Clinical Trial in the US to Evaluate Investigational Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma (Businesswire) - “Legend Biotech…announced the start of a Phase 1 clinical trial in the United States for LB1901, an investigational autologous CD4-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). LB1901 targets CD4, a surface membrane glycoprotein uniformly expressed in most TCL subtypes…The Phase 1 trial is being led by Dr. Swaminathan P. Iyer, Professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center, and is an open label, multi-center and multicohort clinical study in patients with relapsed or refractory PTCL or CTCL…Recruitment in the trial has begun in the U.S.”

Trial status • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Legend Biotech Reports Second Quarter 2021 Financial Results and Recent Highlights (Businesswire) - "Key Upcoming Milestones: Legend Biotech intends to use the data from the CARTIFAN-1 study in support of a regulatory submission to the China Center for Drug Evaluation (CDE) in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM; Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Pharmaceuticals and Medical Devices Agency in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM; Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T-cell lymphoma (TCL) in the United States in 2021."

Japanese regulatory • New P1 trial • Non-US regulatory • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Legend Biotech USA Inc; Trial completion date: Sep 2025 ➔ Dec 2025; Trial primary completion date: Sep 2023 ➔ Dec 2023

Clinical • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • TNFRSF8

Legend Biotech Reports First Quarter 2021 Financial Results and Recent Highlights (Businesswire) - “Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Ministry of Health, Labor and Welfare (JMHLW) in the second half of 2021 seeking approval of cilta-cel for the treatment of adults with RRMM. Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T-cell lymphoma (TCL) in the United States in 2021. Legend Biotech anticipates supporting investigators with publishing a clinical data update from LEGEND-2 study in 2021.”

Clinical data • Japanese regulatory • Trial status • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Phase 1, Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Legend Biotech USA Inc

Clinical • New P1 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma (Businesswire) - "Legend Biotech Corporation...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate LB1901, the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory T-cell lymphoma (TCL). Under this IND, Legend will initiate a Phase 1 clinical study for LB1901 in the United States....A Phase 1, first-in-human, open-label, multicenter, multicohort clinical study will enroll patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) in the United States. The primary objectives of the study are to characterize the safety and tolerability of LB1901 and to determine the recommended Phase 2 dose."

IND • New P1 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Legend Biotech Reports Second Quarter 2020 Financial Results (Businesswire) - "Key Upcoming Milestones...Legend Biotech, in collaboration with Janssen Biotech, Inc., anticipates the presentation of data from the CARTITUDE-1 study at a major medical conference in the second half of 2020; Janssen Biotech, Inc., Legend Biotech’s collaboration partner, expects to initiate the BLA filing for cilta-cel to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency ('EMA') in early 2021; Legend Biotech expects to use the data from CARTIFAN-1 in support of a regulatory submission for approval in China in 2021; Legend Biotech intends to submit an IND application for LB1901 in relapsed or refractory T cell Lymphoma ('TCL') in the second half of 2020."

BLA • European regulatory • IND • Non-US regulatory • P1/2 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma