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Being 'companionable' with new immunotherapy
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."