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EU Awards Genomic Expression €3.7M to Lead Bladder Cancer Diagnostics Project

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NEW YORK (GenomeWeb) – Genomic Expression recently received a €3.7 million ($4.2 million) EU Horizon 2020 grant to advance a urine-based test for bladder cancer.

Over the next three years, the company and selected partners will assess its OneRNA platform to diagnose cancer, select treatment, and measure response and recurrence. The project, dubbed OneRNA4Bladder, is for small- and medium-sized enterprises. Genomic Expression is responsible for contracting out all work associated with it.

CEO Gitte Pedersen said that the study, which will involve roughly 400 patients enrolled at sites across Europe, will generate data that will support the use of the OneRNA platform to help select bladder cancer treatment, which she estimated is a $4.5 billion market worldwide. She said the company received its first tranche of funding in December.

"Bladder cancer is the most expensive cancer to treat, not because of expensive drugs, but because there is an expensive diagnostic and follow-up procedure that involves cytoscopy, which is not only expensive, but also very uncomfortable for the patient," said Pedersen. "Our aim as a company is to reduce cost, invasiveness, life quality, and outcomes."

Genomic Expression was founded in Copenhagen in 2009 when it acquired global rights to IP held by Denmark-based Genomic Expression Aps. It currently maintains an office in Copenhagen and plans to open a CLIA laboratory in the Boston area later this year.

The principle of the company's OneRNA platform is to match patients with therapies by sequencing their tumor RNA. OneRNA consists of a sample preparation method to extract RNA from cells and identify and quantify the transcripts using Illumina next-generation sequencing. The company originally developed the platform to work with microarrays but moved to NGS several years ago.

"Our chemistry was applicable to multiple platforms," said Pedersen of the switch. "When we started out, array-based platforms had a higher penetration in the marketplace, but that changed and so we changed," she said. "The key component of the technology is the sample prep method that allows us to quantify and identify transcripts in samples."

Data analysis is carried out using a cloud-based platform the firm developed together with IBM. The tool generates clinically actionable reports for each tumor based on its gene expression profile. "We do everything from sample to clinical report at this point," Pederson noted.

Based on these results, the company claims to be able to determine if a tumor will respond to new immunotherapies for bladder cancer, such as intravesical BCG, a bacterial strain that is inserted directly into the bladder via catheter, or immune checkpoint inhibitors, such as durvalumab, sold by AstraZeneca as Imfinzi, or nivolumab, sold by BMS as Opdivo.

Given that the OneRNA platform can be used with any tumor type, Genomic Expression views the new project as a vehicle for the firm to tackle a cancer where most agree there is an unmet need, and where recurrence rates hover at around 70 percent. "The end goal is to have better outcomes for bladder cancer patients, or to stratify different patients into risk groups," said Pedersen.

The OneRNA4Bladder project will rely in part on a urine cancer cell filtration device to enable the selection of tumor cells from simple urine samples. According to the project's abstract, the device was developed by and validated in a prospective clinical study involving the Danish Cancer Society. It was later licensed to Genomic Expression.

Patients are being enrolled through sites in the UK and Denmark. Pedersen said that Genomic Expression is also working to establish a site in Spain for OneRNA4Bladder.

As part of the project, the firm will validate the use of the urine cancer cell filtration device to capture tumor cells, which will be assessed with next-generation sequencing for markers associated with bladder cancer. Pedersen noted that Genomic Expression will also use this part of the project to discover new targets, enabling the firm to "instantly implement those markers as new drugs enter the clinic and new markers are discovered" by updating the firm's OneRNACloud.

The company will also use its OneRNA platform as part of an effort to monitor disease response to treatment. Altogether, the effort should yield another indication area for OneRNA in bladder cancer. The company currently has other projects ongoing in ovarian, colon, and breast cancers, Pedersen said.

"All of these projects will create a body of evidence to support implementation of OneRNA into the standard of care in the clinical indications we are pursuing," said Pedersen. "The diagnostic market for bladder cancer is $4.5 billion, and in breast and ovarian cancer, it's $3 billion," she said.

"We are pursuing change in the way patients are being treated," Pedersen said. "On a good day, a drug will work in half of the patients, on a normal day, it is closer to 20 percent.What about the remaining 80 percent? That's what we focus on."

It could be a lucrative strategy for the company. In the abstract for OneRNA4Bladder, the company highlights bladder cancer as a "significant business opportunity" and estimates sales of "over 165 million" within five years of launch.

"The number is based on sales starting after completion of this project, and only covers the sale of that combined solution," said Pedersen.

Genomic Expression hopes to launch the test via its Copenhagen facility, and through its new CLIA lab in Beverly, Massachusetts, later this year, serving the European and US markets, respectively. The launch should add another source of revenue for the firm, which has been making OneRNA available to drug developers to navigate patients into clinical trials for over a year.

OneRNA4Bladder might also deepen Genomic Expression's dialogue with pharma clients that will be interested in data gathered via the project, Pedersen noted.

"We will have patient samples on a continuum through the care program that will be analyzed using multiple methods, one of which is OneRNA, and the other [of which] is a set of markers that have been proven to detect bladder cancer," she said.