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Being 'companionable' with new immunotherapy
December 2011
EDIT CONNECT
SHARING OPTIONS:
CARLSBAD, Calif.—Life Technologies Corp. in
late October
announced it signed an agreement with GlaxoSmithKline (GSK)
Biologicals SA to
develop a companion diagnostic test to be used with a GSK therapeutic
candidate, MAGE-A3, which is to be used in the area of
cancer immunotherapy.
Specifically, Life Technologies will develop a qPCR-based molecular diagnostic
assay for MAGE-A3 that is designed to identify
patients likely to benefit from
the immunotherapy.
The potential MAGE-A3 immunotherapy product is
currently
being evaluated in two clinical trials. The Phase III clinical study MAGRIT,
reportedly the largest lung cancer treatment study ever
conducted, is
evaluating its efficacy and safety as an adjuvant treatment in resected,
non-small cell lung cancer. The Phase III clinical study DERMA
is evaluating
the efficacy and safety of MAGE-A3 as an adjuvant treatment in patients whose
melanoma has invaded the lymph nodes.
"Life Technologies has a long history of providing enabling
technologies to pharma. Our genomic analysis products
are utilized in pharma
R&D, biomarker discovery and validation and various clinical trial phases,"
Kim Caple, head of molecular diagnostics at
Life Technologies, tells ddn. "Certain of our products offer unique advantages in
ease of use and performance for multiplexing gene expression
and SNP clinical
testing. GSK was utilizing Life Technologies' multi-gene gene expression
product in development of the MAGE-A3 ASCI therapy. GSK
evaluated options for
development and commercialization of an in-vitro diagnostic version of the multi-gene gene expression
assay and
determined Life Technologies would be a good partner for this
effort."
Life's companion
diagnostic will be developed utilizing the
company's Taqman Array Card (TAC) technology which is designed for ease of use,
and is, Caple says,
"currently an ideal fit for researchers looking to assay
panels of genes." It is not, however, available or intended for any animal or
human
therapeutic or diagnostic use. The companion diagnostic assays developed
using the technology will be submitted for premarket approval by U.S. Food and
Drug Administration, though.
"Life Technologies' platform technologies, such as qPCR, are
allowing biological knowledge to be applied in multiple markets,
including
companion diagnostics," says Caple, and adds she looks forward to demonstrating
through the partnership with GSK "how using genetic
analysis may further help
select patients likely to benefit from such a treatment approach."
According
to Caple, Life Technologies is in a unique position
to be a key partner for companies in need of companion diagnostics not just
because of the company
's technology platforms but also because of its expertise
in navigating global regulations, manufacturing and commercialization.
Under the terms of the agreement Life Technologies will, in
conjunction with GSK and upon validation in the current
Phase III trial,
develop and commercialize the qPCR-based test to detect MAGE-A3 positive
patients most likely to benefit from MAGE-A3 ASCI. Financial
and other terms of
the deal were not disclosed.
GSK and Alnylam
partner on RNAi technology for vaccine
production
CAMBRIDGE, Mass.—GlaxoSmithKline (GSK) also
recently formed
a collaboration with Alnylam Pharmaceuticals Inc.
that is focused on Alnylam's
VaxiRNA technology for certain GSK vaccine products, including influenza.
GSK is the first company to form a collaboration accessing
the new platform. The collaboration is focused initially on influenza vaccine
production
in cell culture systems. Under the terms of the agreement, GSK will
provide funding and certain milestone payments to Alnylam. If successfully
applied
in the manufacture of commercial product, Alnylam will receive payments
on unit product sales. In addition, GSK has obtained an option for VaxiRNA
applications toward two additional vaccine products.
VaxiRNA is a new RNAi technology for the
enhanced production
of viruses used in the manufacture of vaccine products. The platform applies
siRNAs for the silencing of specific genes that limit
or prevent efficient
growth of viruses in vaccine manufacturing systems, including those in cell
culture and eggs. The VaxiRNA platform stems from work
Alnylam has performed as
part of its Alnylam Biotherapeutics efforts, where RNAi technology has been
applied to improve the manufacture of biotherapeutic products such as
recombinant proteins and monoclonal antibodies.
According to Alnylam, the platform "addresses
the
significant unmet commercial need for innovative technologies that can improve
the manufacture of vaccine products, especially where vaccine
production is a
limiting factor for the scale and speed of global immunization needs." Code: E121113 Back |
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