SAN DIEGO— In hopes of furthering options for precision medicine, Illumina Inc. has announced collaborative partnerships with AstraZeneca, Janssen Biotech Inc. and Sanofi to develop a universal next-generation sequencing (NGS)-based oncology system that will be utilized in clinical trials of cancer therapies to generate a multigene panel for therapeutic selection.
Illumina will be working with its partners to generate assays that can detect and measure multiple variants at once to support clinical trials, with the goal of netting approval from relevant regulatory agencies and commercializing the tests. In conjunction with this effort, Illumina is also collaborating with key thought leaders in the industry to establish standards for NGS-based assays in routine clinical oncology practice and define regulatory frameworks. The companies hope to make the move from single-analyte companion diagnostics to panel-based assays that can select for companion therapeutics.
“This partnership has the potential to deliver an unprecedented amount of clinical information from a single test,” Ruth March, vice president of Personalized Healthcare & Biomarkers at AstraZeneca, said in a press release. “Illumina’s technology will inform doctors about the molecular make-up of their patients’ tumors, enabling them to match medicines to the drivers of disease. Our aim is that doctors can use these tests to prescribe the right drugs to the right patients—bringing benefits to healthcare professionals, payers and patients alike.”
In Illumina’s work with AstraZeneca, the latter will apply Illumina’s technology to a novel companion diagnostic test in pivotal studies for an investigational oncology compound, in what is expected to be one of the first NGS-based companion diagnostic tests for a novel drug. Illumina’s NGS technology, AstraZeneca notes in a press release, “allows rapid sequencing of multiple genes in a much faster and cheaper way than traditional DNA sequencing methods. Under the collaboration, it will be used to screen a panel of several gene sequences, scanning for all possible genetic variants—known and unknown—rather than specified mutations from a single tumor sample.”
“Building on our experience with the MiSeqDx, the only FDA-cleared NGS platform, as well as the additional regulatory expertise we gained with the acquisition of Myraqa, Illumina is developing the universal test system to support our partners’ oncology drug pipelines,” Dr. Rick Klausner, chief medical officer at Illumina, commented in a statement. “These agreements represent the deep engagement between Illumina and the pharma community to create the technical, clinical, regulatory and ultimately commercial solutions for the next generation of molecular oncology. We’re excited to be working together to maximize benefits to patients with cancer.”
Zacks Equity Research is optimistic about this initiative, stating that “We strongly believe such strategic partnerships will act as a major breakthrough in establishing Illumina as a forerunner in NGS systems worldwide.” Furthermore, “Current medical data depicts the necessity of this new system,” says Zacks, an opinion Illumina supports, noting that “To date, 125 known cancer driver genes have been discovered—71 tumor suppressors and 54 oncogenes—that drive tumor growth through 12 cellular signaling pathways. While today 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 new targeted therapies, there is growing need for new companion diagnostic tests.”
In related news, Sept. 8 saw Illumina announcing, along with several other institutions, the establishment of the Actionable Genome Consortium, which will seek to recommend openly published standards for the widespread use of NGS to guide decision-making in clinical oncology. The Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center are also founding members of this initiative.
“The transition to patient-centered companion therapeutics marks a new era for oncology, and we are pleased to see pharmaceutical companies working with Illumina on a universal platform to bring life-saving treatments through their development pipelines. This is the type of collaboration that will make real progress for patients,” Dr. Ellen V. Sigal, chair and founder of Friends of Cancer Research, said of Illumina’s partnership with AstraZeneca, Sanofi and Janssen.