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

SOMERSET, NJ, USA I December 14, 2020 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, today 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.

LB1901 is an investigational CAR-T product targeting CD4, which is a surface membrane glycoprotein uniformly expressed in a majority of TCL subtypes. 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.

TCL is a heterogeneous group of disorders accounting for less than 15 percent of Non-Hodgkin lymphoma cases in the US.1,2 PTCL comprises subtypes which are uncommon and often aggressive, with a 5-year overall survival of 39% that varies by subtype.3,4 Cutaneous T-cell lymphomas are a group of T-cell malignancies, which occur primarily in the skin.5 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.

“The FDA’s clearance of Legend’s IND application for LB1901 is a milestone representative of the company’s scientific expertise in cell therapy innovation,” said Ying Huang, PhD, Chief Executive Officer and Chief Financial Officer of Legend Biotech. “We look forward to working with the investigators as we explore its potential in meeting the great unmet medical needs in the TCL population.”

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 more than 800 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 cutting edge cell therapies for patients in need.

1 Scherer LD, Brenner MK, Mamonkln M. Chimeric antigen receptors for T-cell malignancies. Frontiers in Oncology. 2019 March;9(article 126):1-10.
2 American Cancer Society. Types of T-cell Lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/t-cell-lymphoma.html. Accessed December 2020.
3 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.
4 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.
5 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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