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Source: ©

Thermo Fisher Scientific said it will develop and commercialize a next-generation sequencing (NGS) oncology companion diagnostic (CDx) for Agios Pharmaceuticals’ Phase III cancer candidate ivosidenib (AG-120). The value of the companies’ agreement was not disclosed.

The companion diagnostic will be designed to identify isocitrate dehydrogenase 1 (IDH1) mutations in patients with cholangiocarcinoma, a rare form of cancer that affects the human bile duct system. Thermo Fisher cited a 2002 study showing that annual incidences of the disease were estimated to be from 1-2 per 100,000, with rates on the rise globally over the last several decades.

Ivosidenib is an IDH1 inhibitor currently in the Phase III ClarIDHy trial (NCT02989857) assessing the candidate in patients with advanced IDH1m positive cholangiocarcinoma. Thermo Fisher is Agios’ technology partner in ClarIDHy, providing NGS for all tumor samples as inclusion criteria for enrollment.

Upon validation of the CDx, Thermo Fisher will submit a supplemental premarket approval application (PMA) to expand clinical claims for its multi-therapy NGS test, now under FDA review.

Thermo Fisher said in November 2016 that it filed the final module of a PMA application for its Oncomine Universal Dx Test, a multi-gene, NGS-based assay for non-small cell lung cancer (NSCLC). If approved, the universal gene panel could be the first of its kind in the U.S., and would serve as a CDx for selecting patients for specific NSCLC therapies. The test was developed as part of Thermo Fisher’s long-term collaboration with Novartis and Pfizer, launched in 2015.

“By supplementing our existing test, instead of developing a new one, we are helping our pharmaceutical partners expedite their drug development programs so that patients can potentially benefit more quickly from targeted therapies,” Joydeep Goswami, Ph.D., president of clinical next-generation sequencing and oncology at Thermo Fisher, said in a statement. “This agreement with Agios underscores our continued commitment to help bring precision oncology to the forefront through the use of next-generation sequencing technology.”

Thermo Fisher's NGS-based test is designed to simultaneously screen patient tumor samples for multiple gene variants, reducing the need to perform numerous sequential analyses in order to generate a relevant tumor profile. Thermo Fisher said it will retain rights to commercialize the test globally, and will lead all filings needed to obtain clearance from regional regulatory agencies.

The CDx in development will use Thermo Fisher's Ion PGM Dx System, Ion AmpliSeq technology and content from its Oncomine portfolio of gene targets, the company added.

The Ion PGM Dx System is an in vitro diagnostic NGS platform designed to enable clinical labs to develop molecular diagnostic assays by delivering the performance of the company’s Ion Torrent™ PGM system. Ion AmpliSeq is designed to enable simultaneous sequencing of hundreds of genes, with high reproducibility and rapid turnaround time.

According to Thermo Fisher, use of an approved multi-gene CDx to simultaneously screen patients for targeted therapies is a shift away from the conventional testing method of running several, single-biomarker analyses in sequence to identify tumor profiles. The company is seeking to assess the suitability of multiple therapies through a single test, rather than retain the current one-test, one-drug paradigm.

Ivosidenib is one of three candidates Agios is developing as inhibitors of IDH1 and/or IDH2 proteins; the other two are enasidenib, which is being developed through a collaboration with Celgene that could yield Agios up to $120 million in milestone payments, plus royalties on net sales; and AG-881, which is also licensed from Celgene and could generate up to $70 million in milestone payments for Agios.

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