Lion Biotechnologies Enters Clinical Trial Grant Agreement With Moffitt Cancer Center
July 30 2014 - 8:00AM
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company
that is developing novel cancer immunotherapies based on tumor
infiltrating lymphocytes (TILs), today announced that it has
entered into a clinical trial grant agreement with Moffitt Cancer
Center to expand an ongoing Phase 1 study of TILs combined with
ipilimumab in patients with metastatic melanoma.
Under the agreement, Lion will give Moffitt funding to enroll an
additional ten qualified patients into the clinical trial, bringing
the total number of subjects to 20. The primary objective of the
trial is to evaluate the safety and preliminary efficacy of
administering ipilimumab in combination with TILs as a first-line
therapy for patients with metastatic melanoma. Secondary outcome
measures include overall response rate, or tumor shrinkage, and
progression-free survival.
Marketed by Bristol-Myers Squibb as Yervoy®, ipilimumab is an
immune checkpoint inhibitor that the FDA approved for the treatment
of metastatic melanoma in 2011. TIL therapy, an experimental
melanoma treatment that was developed at the National Cancer
Institute, is a type of adoptive cell therapy that is made by
extracting T-cells from patients' own tumors, expanding them by
thousands in a laboratory, and injecting them back into the
patient. In the expanded trial, the co-stimulatory antibody CD137
will be used to accelerate the growth of these T-cells.
"Despite major treatment advances in recent years, metastatic
melanoma is still a deadly disease for which new therapeutic
approaches are urgently needed," commented Amod Sarnaik, MD, the
trial's principal investigator and a leading expert in adoptive
cell transfer. "Clinical evidence suggests that combining TILs with
checkpoint inhibitors, such as ipilimumab, may provide greater
benefit to a larger number of patients than either therapy alone.
We look forward to further investigating the synergies of this
promising treatment combination in the expanded trial, which we are
actively enrolling."
For more information on the clinical trial, please call Moffitt
Cancer Center at (813) 745-1085 or visit
clinicaltrials.gov/show/NCT01701674.
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 4 metastatic
melanoma, and is based on a clinical CRADA with the National Cancer
Institute. TIL therapy is also being evaluated in
physician-sponsored clinical trials at MD Anderson Cancer Center
and the H. Lee Moffitt Cancer Center & Research Institute. For
more information, please visit http://www.lionbio.com.
About Moffitt Cancer Center
Located in Tampa, Florida, Moffitt is one of only 41 National
Cancer Institute-designated Comprehensive Cancer Centers, a
distinction that recognizes Moffitt's excellence in research, its
contributions to clinical trials, prevention and cancer control.
Moffitt is the top-ranked cancer hospital in the Southeast and has
been listed in U.S. News & World Report's "Best Hospitals" for
cancer since 1999. With more than 4,500 employees, Moffitt has an
economic impact on Florida of nearly $1.6 billion. For more
information, please visit MOFFITT.org.
Forward-Looking Statements
This press release contains certain forward-looking statements
that are subject to a number of risks and uncertainties, including
the risk that the use of ipilimumab in combination with TILs will
not produce a positive outcome as a first-line therapy for patients
with metastatic melanoma. Additional risks and uncertainties are
described in Lion Biotechnologies' most recently filed annual
report on Form 10-K. Except as required by law, Lion
Biotechnologies 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 Jain Ogawa
646-378-2949
gogawa@troutgroup.com