Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relaps...
15 December 2020 - 12:00AM
Business Wire
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.
Cautions Concerning Forward-Looking Statements
This information constitutes forward-looking statements relating
to the business of Legend, including express or implied discussions
regarding the clinical development of its product candidates and
potential attributes and benefits of such product candidates. Such
forward-looking statements reflect the current views of Legend’s
management regarding future events, and involve known and unknown
risks, uncertainties and other factors that may cause actual
results to be materially different from any future results,
performance or achievements expressed or implied by such
statements. In particular, Legend’s expectations could be affected
by, among other things, uncertainties involved in the development
of new pharmaceutical products; unexpected clinical trial results,
including additional analysis of existing clinical data or
unexpected new clinical data; unexpected regulatory actions or
delays or government regulation generally; Legend’s ability to
obtain or maintain patent or other proprietary intellectual
property protection; competition in general; government, industry,
and general public pricing and other political pressures. Should
one or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those described herein as anticipated, believed,
estimated or expected.
The safety and efficacy of the product candidates and/or uses
under investigation have not been established. There is no
guarantee that the product candidates will receive health authority
approval or become commercially available in any country for the
uses being investigated.
The information in this press release speaks only as of the date
hereof. Legend assumes no duty to update the information to reflect
subsequent developments. Readers should not rely upon the
information on this page as current or accurate after its
publication date.
________________________________ 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.
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For Media and Investor Relations inquiries, please
contact: Jessie Yeung, Head of Corporate Finance and Investor
Relations, Legend Biotech jessie.yeung@legendbiotech.com or
investor@legendbiotech.com
Surabhi Verma, Manager of Investor Relations and Corporate
Communications, Legend Biotech Surabhi.verma@legendbiotech.com or
media@legendbiotech.com
For Medical Affairs inquiries, please contact: Tonia
Nesheiwat, Executive Director, Medical Affairs, Legend Biotech
tonia.nesheiwat@legendbiotech.com or
medicalinformation@legendbiotech.com
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