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

SOMERSET, NJ, USA I September 13, 2021 I Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, has 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 trial follows the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application submitted by Legend Biotech.

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 (NCT04712864). Recruitment in the trial has begun in the U.S.

“We are excited by the promise of LB1901, and we look forward to further evaluating the safety and tolerability of LB1901. Determining the optimal dose for subsequent evaluation is one of the key objectives of this trial,” said Dr. Lida Pacaud, Vice President of Clinical Development at Legend Biotech. “The number of patients who relapse or are refractory to current TCL treatments is significant, and this trial will provide important information about the potential of CAR-T therapy to treat this disease.”

T-cell lymphoma is a heterogeneous group of lymphoid malignancies that account for less than 15 percent of non-Hodgkin’s lymphoma cases in the US.i,ii PTCL comprises subtypes that are uncommon and often aggressive, with a 5-year overall survival of only 39%.iii,iv CTCL are a group of T-cell malignancies that occur primarily in the skin.v Despite current treatment options, a substantial proportion of patients with PTCL or CTCL experiences relapse. A high unmet medical need remains for patients with relapsed or refractory PTCL and CTCL.

About the Clinical Development Program

LB1901-TCL-001 (NCT04712864) is a Phase 1 open-label, multicenter study of LB1901 in patients with histologically confirmed CD4+ RR PTCL (PTCL not otherwise specified, or PTCL-NOS, and angioimmunoblastic T cell lymphoma, or AITL) or RR CTCL (mycosis fungoides and Sézary syndrome). The primary objectives are to characterize the safety and tolerability of LB1901 and determine the optimal dose.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 900 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need. We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

i Scherer LD, Brenner MK, Mamonkln M. Chimeric antigen receptors for T-cell malignancies. Frontiers in Oncology. 2019 March;9(article 126):1-10.

ii American Cancer Society. Types of T-cell Lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/t-cell-lymphoma.html. Accessed August 2021.

iii Casulo C, O’Connor O, Shustov A, Fanale M, Friedberg JW, Leonard JP, et al. T-cell lymphoma: Recent advances in characterization and new opportunities for treatment. J Natl Cancer Inst. 2017;109(2):1-9.

iv Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A systematic review and meta-analysis of front-line anthracycline based chemotherapy regimens for peripheral T-cell lymphoma. ISRN Hematol. 2011;2011:623924.

v Scarfo I, Frigault M, Maus M. CAR-based approaches to cutaneous T-cell lymphoma. Frontiers in Oncology. 2019;9(article 259):1-6.

SOURCE: Legend Biotech

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