CAMBRIDGE, U.K.—Horizon Discovery Group plc, a leading provider of research tools to support translational genomics and the development of personalized medicines, will be providing genomic reference materials to support the second phase of Cancer Research UK’s Stratified Medicine Programme (SMP). Financial details of the agreement were not disclosed.
The work will focus on supporting the validation of a Cancer Research UK SMP next-generation sequencing (NGS) targeted enrichment panel, using Horizon’s HDx human genomic reference materials. The NGS project involves multi-gene, multi-aberration tumor analysis and is being run in CPA-, GLP- and ISO-accredited laboratories with a UK National External Quality Assessment Service assessment. These reference materials will support run-to-run and lab-to-lab longitudinal assessment of performance of the NGS technology.
Many factors contribute to variability in the quality of clinical samples, which is currently a concern within molecular pathology laboratories working toward the clinical application of NGS panels for tumor screening. To address this, Cancer Research UK will use Horizon’s precisely defined formalin-compromised reference standards to assess the performance of Cancer Research UK’s SMP NGS, in order to inform any necessary changes in clinical practice surrounding preparation of FFPE samples for downstream NGS analysis.
Dr. Paul Morrill, president of products at Horizon Discovery, said: “Research programs such as Cancer Research UK’s Stratified Medicine Programme form a vital piece of the puzzle in the drive toward personalized, or stratified, medicine as a routine approach for the testing and treatment of cancer. We are delighted to have been chosen to support Cancer Research UK on the delivery of phase two of this project.”
The scope of the project involves Horizon’s Diagnostics business unit providing renewable, genetically defined reference materials representing a range of genetic aberrations and containing defined allelic mutation frequencies. The reference materials developed will enable reliable comparison of assay performance across sequencing platforms, targeted assays and laboratories by providing a common universal reference point.
“Research into stratified medicine is helping us to understand the genetic changes that drive cancer and to find out how different cancers respond to treatment. Ensuring accuracy in genetic assessment of tumors is a vital part of this process,” commented Dr. Ian Walker, head of Cancer Research UK’s SMP activity, “and we welcome Horizon’s involvement in assisting Cancer Research UK with taking the Stratified Medicine Programme forwards.”
In phase two of the SMP project, Cancer Research UK will work with the Experimental Cancer Medicine Centre (ECMC) network and national genetic testing laboratories to develop a national screening program for lung cancer samples in the National Health Service. Once screened, these results will be used to place patients on the National Lung Matrix Trial, run by the Cancer Research UK Clinical Trials Unit in Birmingham.
Also, in February, Horizon announced that together with the Centre for Process Innovation (CPI), a U.K.-based technology innovation center and part of the High Value Manufacturing Catapult, and Prof. Alan Dickson of the University of Manchester, they have been selected to receive a funding award of £1.67 million (approximately $2.56 million). The Biotechnology and Biological Sciences Research Council (BBSRC) will provide £422,000 in funding, and the remainder will be from Innovate UK. Horizon will receive up to £747,000 (approximately $1.14 million) which will be deployed within research performed in its Bioproduction business. The funding is awarded under Innovate UK’s new Industrial Biotechnology Catalyst scheme.
This funding will support the development of a commercially valuable enhancement to Chinese hamster ovary (CHO) cell lines, critical tools for biomanufacturing of high-value biopharmaceuticals.
The project aims to develop a suite of engineered CHO cell lines containing a range of modifications designed to control and improve metabolic performance of these cells for the production of biological medicines. By focusing on combinatorial gene editing, the consortium aims to generate robust phenotypes, which will not only enhance understanding of the CHO expression platform, but will ultimately lead to successful industrial translation. The project is designed to decrease the risk associated with the introduction of high levels of innovation in cell line engineering while establishing a platform that can be made broadly accessible across the biopharmaceutical industry, in the United Kingdom and beyond.
Horizon’s gene editing platform will be used to manipulate pathways identified and subsequently tested by University of Manchester to generate proof of concept. The performance of novel genotypes will be assessed in fermentors and scaled up to “manufacture-ready” processes at the CPI and its National Biologics Manufacturing Centre business unit, to ensure that project outputs are translatable into the manufacturing setting and outcomes are widely disseminated.
“Cell line development through targeted gene editing will be critical in delivering the next generation of biological medicines,” says Brian Burke, Horizon’s business development director. “This funding award from Innovate UK will enable the development of an engineered CHO cell line toolkit that will drive new bioprocessing solutions beyond the term of the project, giving the bioprocessing community a foundation upon which further improvements in cell line systems can be built.”
“Our research focuses on increased molecular understanding of industrially relevant mammalian cell expression systems and how such information can be used to enhance the commercial viability of bioprocessing,” Dickson said. “Partnering with Horizon and the CPI enables us to take this research to the next stage, with the aim of improving bioprocesses for application in industry. We are excited to see where it will lead.”