Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a
global biotechnology company developing, manufacturing and
commercializing novel therapies to treat life-threatening diseases,
announced today that the U.S. Food and Drug Administration (FDA)
has cleared Legend Biotech’s Investigational New Drug (IND)
application to proceed with the clinical development of LB2102, an
investigational, autologous chimeric antigen receptor T-cell
(CAR-T) therapy for the treatment of adult patients with extensive
stage small cell lung cancer (SCLC).
LB2102 is designed to selectively target delta-like ligand 3
(DLL-3), a ligand that is highly restricted to various
malignancies, including SCLC, large cell neuroendocrine carcinoma
(LCNEC), certain other neuroendocrine tumors and some prostate
cancers. DLL-3 has also been linked to tumor growth, migration and
invasion.1
The Phase 1, first-in-human, open-label clinical study is
designed to evaluate the safety and preliminary efficacy of LB2102
in subjects with extensive stage SCLC and patients with LCNEC, as
well as to determine the recommended dose for Phase 2.
“Lung cancer is a debilitating disease that often spreads
quickly. On average, only seven percent of patients with SCLC are
alive five years after receiving their diagnosis,” said Lida
Pacaud, M.D., Vice-President of Clinical Development at Legend
Biotech. “We are eagerly awaiting the start of this Phase 1 trial,
and we hope that the study will provide much needed insight into
the potential of this investigational CAR-T therapy.”
About Small Cell Lung Cancer
Lung cancer is a leading cause of cancer deaths, contributing to
25 percent of all cancer-related fatalities annually in the United
States.2 Small cell lung cancer (SCLC) is the most aggressive, and
accounts for roughly 10-15 percent of lung cancer cases in the
United States.3,4 An estimated 30,000 to 35,000 people are newly
diagnosed with the disease each year.4 This cancer becomes more
difficult to treat once it has spread and becomes extensive stage
SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed
with metastatic SCLC.3,5
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to
treating, and one day curing, life-threatening diseases.
Headquartered in Somerset, New Jersey, we are developing advanced
cell therapies across a diverse array of technology platforms,
including autologous and allogeneic chimeric antigen receptor
T-cell and natural killer (NK) cell-based immunotherapy. From our
three R&D sites around the world, we apply these innovative
technologies to pursue the discovery of cutting-edge therapeutics
for patients worldwide.
Learn more at www.legendbiotech.com and follow us on Twitter and
LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, constitute “forward-looking
statements” within the meaning of The Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited
to, statements relating to Legend Biotech’s strategies and
objectives; statements relating to LB2102, including potential
indications for, and Legend Biotech’s other expectations for, that
investigational CAR-T therapy; statements about submissions for
LB2102 to, and the progress of such submissions with, the U.S. Food
and Drug Administration (FDA) and other regulatory authorities; the
anticipated timing of, and ability to progress, clinical trials;
the submission of Investigational New Drug (IND) applications to,
and maintenance of such applications with, regulatory authorities;
the ability to generate, analyze and present data from clinical
trials; and the potential benefits of Legend Biotech’s product
candidates. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors. Legend Biotech’s expectations could be
affected by, among other things, uncertainties involved in the
development of new pharmaceutical products; unexpected clinical
trial results, including as a result of additional analysis of
existing clinical data or unexpected new clinical data; unexpected
regulatory actions or delays, including requests for additional
safety and/or efficacy data or analysis of data, or government
regulation generally; unexpected delays as a result of actions
undertaken, or failures to act, by our third party partners;
uncertainties arising from challenges to Legend Biotech’s patent or
other proprietary intellectual property protection, including the
uncertainties involved in the U.S. litigation process; competition
in general; government, industry, and general public pricing and
other political pressures; the duration and severity of the
COVID-19 pandemic and governmental and regulatory measures
implemented in response to the evolving situation; as well as the
other factors discussed in the “Risk Factors” section of the Legend
Biotech’s Annual Report on Form 20-F filed with the Securities and
Exchange Commission on March 31, 2022. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those described in this press release as anticipated,
believed, estimated or expected. Any forward-looking statements
contained in this press release speak only as of the date of this
press release. Legend Biotech specifically disclaims any obligation
to update any forward-looking statement, whether as a result of new
information, future events or otherwise.
References
1 Furuta M. DLL3 regulates the migration and invasion of small
cell lung cancer by modulating SNAI1. Cancer Science.
2019;110:1599–1608.
2 American Cancer Society. “Key Statistics for Lung Cancer.”
https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.
Accessed November 2022.
3 Byers LA, Rudin CM. Small cell lung cancer: where do we go
from here? Cancer. 2015;121(5):664-72.
4 Rare Diseases. “Rare Disease Database.”
https://rarediseases.org/rare-diseases/small-cell-lung-cancer/.
Accessed November 2022.
5 Gong J, Salgia R. Managing patients with relapsed small-cell
lung cancer. J Oncol Pract. 2018;14(6):359-66.
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version on businesswire.com: https://www.businesswire.com/news/home/20221121005189/en/
Press Contact: Tina Carter, Corporate Communications
Lead, Legend Biotech tina.carter@legendbiotech.com (908)
331-5025
Investor Contacts: Joanne Choi, Senior Manager, Investor
Relations, Legend Biotech joanne.choi@legendbiotech.com
Crystal Chen, Manager, Investor Relations, Legend Biotech
crystal.chen@legendbiotech.com
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