Being 'companionable' with new immunotherapy

CARLSBAD, Calif.—Life Technologies Corp. in late Octoberannounced it signed an agreement with GlaxoSmithKline (GSK) Biologicals SA todevelop a companion diagnostic test to be used with a GSK therapeuticcandidate, MAGE-A3, which is to be used in the area of cancer immunotherapy.Specifically, Life Technologies will develop a qPCR-based molecular diagnosticassay for MAGE-A3 that is designed to identify patients likely to benefit fromthe immunotherapy.

The potential MAGE-A3 immunotherapy product is currentlybeing evaluated in two clinical trials. The Phase III clinical study MAGRIT,reportedly the largest lung cancer treatment study ever conducted, isevaluating its efficacy and safety as an adjuvant treatment in resected,non-small cell lung cancer. The Phase III clinical study DERMA is evaluatingthe efficacy and safety of MAGE-A3 as an adjuvant treatment in patients whosemelanoma has invaded the lymph nodes.

"Life Technologies has a long history of providing enablingtechnologies to pharma. Our genomic analysis products are utilized in pharmaR&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 inease of use and performance for multiplexing gene expression and SNP clinicaltesting. GSK was utilizing Life Technologies' multi-gene gene expressionproduct in development of the MAGE-A3 ASCI therapy. GSK evaluated options fordevelopment and commercialization of an in-vitro diagnostic version of the multi-gene gene expressionassay and determined Life Technologies would be a good partner for thiseffort."

Life's companion diagnostic will be developed utilizing thecompany'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 assaypanels of genes." It is not, however, available or intended for any animal orhuman therapeutic or diagnostic use. The companion diagnostic assays developedusing the technology will be submitted for premarket approval by U.S. Food andDrug Administration, though.

"Life Technologies' platform technologies, such as qPCR, areallowing biological knowledge to be applied in multiple markets, includingcompanion diagnostics," says Caple, and adds she looks forward to demonstratingthrough the partnership with GSK "how using genetic analysis may further helpselect patients likely to benefit from such a treatment approach."

According to Caple, Life Technologies is in a unique positionto be a key partner for companies in need of companion diagnostics not justbecause of the company's technology platforms but also because of its expertisein navigating global regulations, manufacturing and commercialization.

Under the terms of the agreement Life Technologies will, inconjunction with GSK and upon validation in the current Phase III trial,develop and commercialize the qPCR-based test to detect MAGE-A3 positivepatients most likely to benefit from MAGE-A3 ASCI. Financial and other terms ofthe deal were not disclosed.

GSK and Alnylam partner on RNAi technology for vaccineproduction

CAMBRIDGE, Mass.—GlaxoSmithKline (GSK) also recently formeda collaboration with Alnylam Pharmaceuticals Inc. that is focused on Alnylam'sVaxiRNA technology for certain GSK vaccine products, including influenza.

GSK is the first company to form a collaboration accessingthe new platform. The collaboration is focused initially on influenza vaccineproduction in cell culture systems. Under the terms of the agreement, GSK willprovide funding and certain milestone payments to Alnylam. If successfullyapplied in the manufacture of commercial product, Alnylam will receive paymentson unit product sales. In addition, GSK has obtained an option for VaxiRNAapplications toward two additional vaccine products.

VaxiRNA is a new RNAi technology for the enhanced productionof viruses used in the manufacture of vaccine products. The platform appliessiRNAs for the silencing of specific genes that limit or prevent efficientgrowth of viruses in vaccine manufacturing systems, including those in cellculture and eggs. The VaxiRNA platform stems from work Alnylam has performed aspart of its Alnylam Biotherapeutics efforts, where RNAi technology has beenapplied to improve the manufacture of biotherapeutic products such asrecombinant proteins and monoclonal antibodies.

According to Alnylam, the platform "addresses thesignificant unmet commercial need for innovative technologies that can improvethe manufacture of vaccine products, especially where vaccine production is alimiting factor for the scale and speed of global immunization needs."