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Targeted Medicine Changes Clinical Trials

Recent trends in biotech research point to faster, more efficient and less costly drug development for pharmaceutical companies.

Back in the year 2000, mapping out the human genome was a near fantasy for scientists. Fourteen years and $1 billion later, the whole human genome is sorted and mapped by the way of 3 billion genetic letters.

For the past decade scientists and biotech firms have been attempting to make use of the information by detecting signatures in genes called biomarkers to associate specific genetic variants with disease.

With gene-specific knowledge in mind, physicians could treat individuals based on their specific variation of a disease rather than a one-size-fits-all approach to treatment.

“You can develop smart drugs based on your genotype,” said Ardy Arianpour, chief strategy officer for Pathway Genomics Corp., a genetic testing firm in San Diego. “Targeted molecular therapy and personalized medicine allows us to treat the individual, not the population.”

The End Goal

Personalized medicine is the end goal because it allows doctors to choose drugs aimed at the patients’ specific molecular machinery. However, the path to personalized medicine is led by companion diagnostics — tests used to determine the how well certain drugs work for a targeted patient group.

With relevant companion diagnostics in hand, a drug developer could carefully select a patient pool that would be tested during phase three clinical trials. By choosing subjects most likely to respond to the drug due to their genetic makeup, the drug candidate may be more likely to pass regulatory approval.

The 13-year-long government-backed Human Genome Project cost $1 billion to complete, but costs for genome sequencing have dramatically fallen to $350,000 in 2008 and earlier this year Illumina Inc. announced a landmark $1,000 human genome sequencing system.

“With science, everything is fantasy first,” Arianpour said. “Biotech has allowed us to reduce the costs, and technology is getting faster and cheaper which will allow us to make precision medicine a reality.”

Use in Clinical Trials

Cypher Genomics Inc., a San Diego-based genome informatics company, has entered into a co-promotion agreement with Illumina to help facilitate the development of genomic-based biomarkers for use in clinical trials. Cypher and Illumina will jointly offer pharmaceutical companies, through Illumina’s sales force, a solution using Illumina’s sequencing technology, Cypher’s biomarker discovery service and the data analytics software platform developed by NextBio, a clinical software firm acquired by Illumina in October 2013.

Cypher’s technology takes data collected in phase two clinical trials and analyzes the data to discover associations between biomarkers and the drug being tested. The information can then be provided to the drug developer so that phase three patient pools can be chosen more strategically.

“It’s a waste of money to give the wrong drug to the wrong patient,” said Ashley Van Zeeland, CEO of Cypher. “We have this information in our DNA, and we should be looking at it before prescribing medication. We want to get the right drug to the right patient at the right time.”

Streamlined Solutions

Big names in the industry are working to streamline companion diagnostics for research and drug development. Illumina, a global leader in DNA sequencing equipment, announced a partnership with Sanofi, AstraZeneca and Janssen Biotech Inc. earlier this month to create a test that measures multiple variants in cancer driver genes.

The idea is to build a universal oncology test that could be used by all companies developing a cancer therapy. The test will consist of 60-70 genes and fusions identified through Illumina’s new partnerships. The universal oncology test will build on Illumina’s FDA-approved diagnostic sequencing platform, MiSeqDx. The partnerships with the drug giants will be three-pronged: a technical partnership for creating the tests; a regulatory partnership for dealing with the FDA and other regulators; and a commercial partnership in which Illumina guarantees it will make the tests available where companies sell their drugs.

The goal is to replace the many tests used by cancer research teams and drug developers to just one test that can be leveraged to conduct registrational trials, said Naomi O’Grady, senior project manager of oncology product marketing at Illumina.

“Patient recruiting is expensive and time-consuming,” O’Grady said. “So having a broad number of patients triaged into studies based on their molecular makeup is a more efficient process for enrolling patients into clinical trials.”

As of 2013 there are 125 discovered cancer driver genes that drive tumor growth through 12 cellular signaling pathways, according to Science magazine. While the number of available targeted therapies is limited, an estimated 800 oncology drugs are in development, many of which are designed to target specific mutations. With the emergence of targeted therapies, there is a growing need for companion diagnostic tests to increase efficiency of clinical trials.

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