Lion Biotechnologies Opens Enrollment in Phase 2 Study of LN-144 for the Treatment of Refractory Metastatic Melanoma
September 21 2015 - 8:46PM
Lion Biotechnologies, Inc. (Nasdaq:LBIO) a biotechnology company
that is developing novel cancer immunotherapies based on
tumor-infiltrating lymphocytes (TIL), today announced that it has
opened enrollment in a Phase 2 clinical trial of its lead product
candidate, LN-144, for the treatment of refractory metastatic
melanoma.
The single-arm study is expected to enroll approximately 20
evaluable patients with metastatic melanoma whose disease has
progressed following treatment with at least one systemic therapy.
The trial will be conducted at up to five sites.
The purpose of the study is to evaluate the safety, efficacy and
feasibility of autologous TIL infusion (LN-144). The trial's
primary endpoints include safety, and feasibility of LN-144
production using Lion's central manufacturing process. Secondary
outcome measures include an additional feasibility measure of
number of patients successfully infused with LN-144 and best
overall response rate.
LN-144 is an autologous cell therapy of tumor-infiltrating
lymphocytes (TIL) derived from the patient's own tumor and is based
on TIL therapy regimens developed at the National Cancer Institute
(NCI). Following a lymphocyte-depleting preparative regimen,
patients are treated with a single infusion of LN-144 followed by
IL-2. In this study, patients will be evaluated for response
12 weeks after LN-144 infusion. Additionally, patients with
stable disease and responders will be evaluated for
progression-free survival (PFS), and overall survival (OS) for up
to 24 months.
Elma Hawkins, PhD, Lion's president and chief executive officer,
added, "We are encouraged by the consistently robust data from
previous studies of TIL therapy in melanoma treatment at leading
cancer centers. As we continue to evaluate the safety and efficacy
of LN-144 in this study, we also look forward to assessing the
feasibility of manufacturing TIL on a commercial scale, with the
goal of ensuring that this promising therapy can be available for
many patients who may benefit from it."
Manufacturing for LN-144 will take place at a central cGMP
manufacturing facility according to established protocols that are
similar to those in use at NCI. The company expects to present
initial trial data in 2016 in a scientific forum. For more
information on the study, please see ClinicalTrials.gov
(Identifier: NCT02360579).
About Lion Biotechnologies
Lion Biotechnologies, Inc. is a clinical-stage biotechnology
company focused on the development of cancer immunotherapy products
for the treatment of various cancers. The company's lead
product candidate is an adoptive cell therapy using
tumor-infiltrating lymphocytes (TIL) for the treatment of patients
with refractory metastatic melanoma, and is based on a
clinical Cooperative Research and Development Agreement with the
National Cancer Institute. TIL therapy is also being evaluated in
physician-sponsored clinical trials at MD Anderson Cancer Center
and Moffitt Cancer Center. For more information, please
visit http://www.lionbio.com.
Forward Looking Statements
This press release contains certain forward-looking statements
that are subject to a number of risks and uncertainties, including
risks associated with the enrollment of patients, the conduct of
the study, the results of the study, and the other risks described
in the Company's most recently filed quarterly report on Form 10-Q
and annual report on Form 10-K. Except as permitted by law, the
Company undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
CONTACT: Investor Relations
The Trout Group
Gitanjali Ogawa
646-378-2949
Gogawa@troutgroup.com
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