Lion Biotechnologies' Lead Program With National Cancer Institute Demonstrates Positive Results in Patients With Stage 4 Meta...
April 07 2014 - 12:00PM
Lion Biotechnologies, Inc. (OTCBB:LBIO), a biotechnology company
that is developing novel cancer immunotherapies based on tumor
infiltrating lymphocytes (TILs), today announced that Steven A.
Rosenberg, M.D., Ph.D., Chief of Surgery at the National Cancer
Institute (NCI), has presented data showing impressive evidence of
clinical efficacy from a Phase 2 melanoma clinical trial in a
plenary session at the 105th Annual Meeting of the American
Association for Cancer Research. The new data confirmed that TIL
treatment was associated with a high durable objective response
rate in patients with Stage 4 metastatic melanoma, including many
who were refractory to checkpoint inhibitors. Lion is working with
Dr. Rosenberg under a Cooperative Research and Development
Agreement (CRADA) to develop and commercialize this novel TIL
therapy.
Confirming findings from prior Phase 2 studies of TILs, the new
data indicate an overall objective response rate (ORR) of 54% in
101 patients, which represents a significant improvement over
recent clinical data from ipilimumab, marketed as Yervoy (ORR
10-15%), and anti-PD-1 therapy (ORR 31-41%) in Stage 4 metastatic
melanoma patients. In addition, TILs produced clinically meaningful
objective response rates in 19/45 (ORR 42%) patients who were
ipilimumab refractory, and 5/10 (ORR 50%) patients who had
previously progressed on anti-PD1. Four patients with prior
checkpoint failures had complete responses and continue to be
disease free.
Commenting on Dr. Rosenberg's presentation, Jeffrey S. Weber,
M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma
Research Center at Moffitt Cancer Center and member of Lion's
Scientific Advisory Board, stated, "These findings underscore the
potential of TILs to significantly improve survival and tumor
response in patients with advanced metastatic melanoma, either
alone or in combination with other immunotherapeutic agents.
"Checkpoint inhibitors are quickly becoming the standard of care
for metastatic melanoma, but 50 to 60% percent of patients do not
benefit from these agents. We are therefore very encouraged by the
high response rates we see with TILs in patients who are refractory
to these therapies, and who have few, if any, other treatment
options. These impressive data also suggest that further benefit
may occur when TILs are combined with checkpoint protein
inhibitors."
The randomized, Phase 2 clinical trial was conducted at NCI in a
total of 101 patients with advanced metastatic melanoma, who were
equally divided between two treatment groups. Both groups were
treated according to standard TIL protocol using chemoablation, but
the second group also received total body irradiation.
At the time of analysis, 11 of 101 patients from both groups had
achieved complete response and 44 had achieved partial response,
indicating a combined ORR of 54%. Differences between the two
treatment groups will be calculable only after all patients have
been evaluated later this year.
Manish Singh, PhD, Lion's chairman and chief executive officer,
commented, "The outcome of our study with NCI represents an
exciting development, first and foremost for patients, but also for
our company and the groundbreaking technology on which it is based.
In recent years, TILs, chimeric antigen receptors and other forms
of adoptive cell transfer therapy have proved capable of shifting
the cancer treatment paradigm away from delaying progression, and
towards a cure. We look forward to further investigating TIL
therapy in metastatic melanoma, while enhancing the underlying
technology and exploring its potential in other solid tumor
indications."
About TIL therapy
In the early stages of cancer, special immune cells known as
tumor infiltrating lymphocytes (TILs) migrate to the tumor and
launch an attack. However, this effect is usually short-lived
because cancer adapts to evade immune detection and suppress immune
response. Lion's TIL technology is designed to overcome the
immunosuppressive effects of cancer, while leveraging and enhancing
the power of TILs to treat, and potentially cure, all solid
tumors.
Lion's TIL technology has demonstrated robust efficacy in Phase
2 clinical trials, indicating objective response rates of 49% in
Stage 4 metastatic melanoma. Based on an adoptive cell therapy
regimen developed by Steven A. Rosenberg, MD, chief of surgery at
National Cancer Institute (NCI), it is currently in use as a
physician-sponsored investigational treatment for Stage IV
metastatic melanoma at NCI, MD Anderson Cancer Center, and the H.
Lee Moffitt Cancer & Research Institute.
About Lion Biotechnologies
Lion Biotechnologies, Inc. is engaged in the development of
T-cells and engineered T-cells for the treatment of various
cancers. The company's lead product candidate is a ready-to-infuse
autologous T-cell therapy utilizing tumor-infiltrating lymphocytes
(TILs) for the treatment of patients with Stage IV metastatic
melanoma, and is based on a clinical CRADA with the National Cancer
Institute along with physician-sponsored investigational therapy at
the MD Anderson Cancer Center and the H. Lee Moffitt Cancer &
Research Institute. For more information, please visit
http://www.lionbio.com.
CONTACT: Investor Relations
The Trout Group
Gitanjali Jain Ogawa
646-378-2949
gogawa@troutgroup.com