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With $6.5M in Funding, Inivata Seeks Partners to Test Liquid Biopsy Approach for Cancer

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NEW YORK (GenomeWeb) – Following a recent funding round, Cambridge, UK startup Inivata is looking for partners to identify clinical applications for its cell-free circulating tumor DNA analysis platform and to demonstrate its clinical utility.

Inivata, a recent spinout from the University of Cambridge's Cancer Research UK Cambridge Institute, said last week that it raised £4 million ($6.5 million). The funding round was led by technology commercialization firm Imperial Innovations and also included Cambridge Innovation Capital and the Johnson & Johnson Development Corporation, a VC subsidiary of Johnson & Johnson.

Inivata holds an exclusive license from Cancer Research Technology and the University of Cambridge to a circulating tumor DNA analysis technology called Tagged-Amplicon Sequencing, or TAm-Seq, that was developed in Nitzan Rosenfeld's lab at the Cambridge Institute and published two years ago. Rosenfeld is a scientific founder of Inivata, along with Tim Forshew, a former postdoc of Rosenfeld's now at the UCL Cancer Institute; Davina Gale, a member of Rosenfeld's lab; and James Brenton, a group leader at the Cambridge Institute.

According to the company, the technology promises the analysis of cancer in real time from ctDNA in blood samples, or so-called "liquid biopsies," which could have applications in cancer diagnostics and cancer monitoring as well as drug development.

Inivata has its own lab space on the campus of Addenbrooke's Hospital, a University of Cambridge teaching hospital, and is currently looking to hire computational scientists and molecular biologists to build up its staff, which currently counts fewer than 10.

According to CEO Michael Stocum, one of the first tasks will be to transfer the TAm-Seq technology from Rosenfeld's lab to the company, and to make it robust enough for routine clinical use, which will require the implementation of certain quality control elements.

In parallel, the company is looking for collaborations and partnerships with academic, clinical, and industry groups in order to gain access to patient samples from ongoing or completed clinical trials to test its technology.

The goal is "to work together with industry and academic leaders to develop the data that's needed to demonstrate the clinical utility and crystallize what will be the emerging clinical applications" Rosenfeld told Clinical Sequencing News.

TAm-Seq is an amplicon-based sequencing and data analysis method that enables high-sensitivity analysis of cancer mutations in a panel of genes from degraded or dilute samples, such as ctDNA or formalin-fixed paraffin-embedded samples. The approach is flexible, "so we can choose and tweak our assay to different applications depending on the panel's required sensitivity and the cost that would make sense for those applications," Rosenfeld said.

Two years ago, Rosenfeld and Brenton published proof of concept for TAm-Seq in Science Translational Medicine, showing that they can sequence entire exons from ctDNA and detect cancer mutations present with allele frequencies as low as 2 percent, with sensitivity and specificity greater than 97 percent.

For that study, they sequenced the TP53 gene in 46 plasma samples from advanced ovarian cancer patients, analyzed 10 mutations in the plasma of a metastatic breast cancer patient over 16 months, and identified the origin of a metastatic relapse in a patient with multiple primary tumors. They used a combination of Fluidigm-based amplification and Illumina sequencing to conduct the study.

In a publication in the New England Journal of Medicine last year by Rosenfeld and Carlos Caldas, a colleague at the Cambridge Institute, the researchers showed that they could detect ctDNA in almost all of the 30 women with metastatic cancer they analyzed. The level of ctDNA showed greater dynamic range and better correlation with changes in tumor burden than other markers, and it provided the earliest measure of treatment response in about half of patients.

Later last year, Rosenfeld, Caldas, and Brenton published a study in Nature in which they showed that they can track genomic changes in metastatic cancers in response to therapy by exome sequencing of patient plasma samples. For that study, they followed six patients with advanced breast, ovarian, and lung cancer over a period of up to two years.

Rosenfeld said that he and his colleagues have significantly improved the performance of TAm-Seq through changes in sample preparation, sequencing chemistry, and data analysis. He declined to say which target amplification and sequencing platforms the company currently uses, saying that "we retain the flexibility to choose our technologies for the needs of the hour."

"Each project, depending on the questions you are asking of the circulating tumor DNA genome, may have specific needs, and we will customize the platform to that," Stocum said.

For clinical applications, it is "not always justified to go to the extremes of sensitivity," Rosenfeld said, because of cost or other constraints. "Work in the past few years has demonstrated that even with limited sensitivity, especially in the advanced cancers, where the most imminent clinical applications are, you can generate quite a lot of useful data."

Inivata is now trying to find areas of clinical need "where providing this type of information is going to help the clinician take action," Stocum said, either to help select the best therapy or to monitor response to therapy.

In principle, the technology could be applied to any kind of solid tumor where information that is not readily accessible from the tumor itself or its metastases can be extracted from ctDNA. The company has surveyed several solid tumor types and their ctDNA levels and plans to start with four to five different types, he said.

One possible application is in lung cancer, which often develops therapy resistance and where it is difficult to obtain frequent biopsies, he said.

It is unclear yet how Inivata will eventually commercialize its assays. "Based on the applications and tumor types and the indications for use, we will go accordingly in terms of the commercial model," Stocum said. The company could provide testing as a service or sell in vitro diagnostic kits, he added.

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