BOULDER, Colo., May 26, 2020 /PRNewswire/ -- ArcherDX, Inc., today announced a strategic collaboration with AstraZeneca to develop assays to support multiple planned Phase 3 clinical trials for AstraZeneca's targeted immuno-oncology therapeutics.
Under the terms of the agreement, ArcherDX will perform Whole Exome Sequencing (WES) of resected non-small cell lung cancer (NSCLC) patient samples and generate patient-specific circulating tumor DNA (ctDNA) assays. ArcherDX plans to leverage the PCM assays to develop companion diagnostics (CDx) for AstraZeneca's associated therapies, and together, the companies plan to seek global regulatory approval if the Phase 3 clinical trials are completed successfully. The assays are currently for investigational use only.
"While there has been progress in improving adoption of precision oncology for patients with late-stage cancers, there is a pressing need to accelerate access to precision oncology for all patients diagnosed with cancer regardless of the stage or location of the care setting," said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. "AstraZeneca shares this critical mission, and we are pleased to partner with them in the development of biomarker-driven therapies and the expansion of personalized cancer monitoring for all patients. Because Archer's distributed model does not require a centralized laboratory, we intend to distribute regulated products globally. We believe our approach will revolutionize how cancer is managed by measuring cancer progression based on the genomic tumor profile of the individual cancer regardless of where the patient receives care."
ArcherDX's Personalized Cancer Monitoring (PCM) development program is being developed by ArcherDX and is supported by a collaboration led by Professor Charles Swanton of UCL and the Francis Crick Institute to detect evidence of disease progression in lung cancer patients from cell-free ctDNA as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. PCM applies ArcherDX's proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.
"MERMAID-1 is a novel randomized trial using ctDNA to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy," said Charles Swanton, M.D., Ph.D., UCL and the Francis Crick Institute, lead researcher of the TRACERx study. "We hope this approach will lead to better patient outcomes by intensifying treatment in patients most likely to relapse, while avoiding additional chemotherapy after surgery when not needed."
José Baselga, Executive Vice President of Oncology R&D at AstraZeneca, said, "While detecting and monitoring for minimal residual disease has proven challenging in solid tumors, the MERMAID-1 trial and this partnership stand to break new ground in lung cancer. This innovative endeavor is reflective of our strategy to improve cancer outcomes by treating patients as early as possible. It is in this early setting that the chance of cure is higher and identifying personalized, effective treatments could increase survival and improve quality of life."
The master collaboration agreement also allows for expansion into additional disease indications and therapeutic categories.
ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
 TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analyzing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.
This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "plan," "expect," "predict," "potential," "opportunity," "goals," or "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding ArcherDX's plans to leverage the PCM assays to develop CDx for AstraZeneca's associated therapies; the companies' plans to seek global regulatory approval; and the impact of ArcherDX's platform and decentralized approach on how cancer is managed. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.