ArcherDX and UCL Present New Minimal Residual Disease Surveillance Data from their Collaboration at 2020 AACR Virtual Annual Meeting

BOULDER, Colo. and LONDON, April 28, 2020 /PRNewswire/ -- ArcherDX, Inc., UCL and the Francis Crick Institute today announced new data from their research collaboration as part of the Cancer Research UK-funded UCL-sponsored TRACERx study. Based on the on-going collaboration between ArcherDX and UCL, utilizing ArcherDX's AMP^TM technology, the data demonstrated cancer circulating tumor DNA (ctDNA) monitoring for minimal residual disease (MRD) can detect relapse of non-small cell lung cancer (NSCLC) earlier than standard of care imaging surveillance in some instances. Post-operative timepoints were analyzed from 90 TRACERx patients. In patients whose cancer had relapsed and shed ctDNA, the ctDNA was detected at or before relapse with a median lead-time, or time from ctDNA detection to clinical relapse, of 164 days (range: 6 to 1,022 days) in the TRACERx study tracking a median of 200 variants per patient. Furthermore, in non-relapse patients, the assay demonstrated 99.3% clinical specificity within the research data set. Results from the analytical validation of a 50-variant version of the research assay demonstrated 100% specificity with detection down to 0.003% variant fractions at high cell-free (cfDNA) input levels.ⁱ 

With more sensitive detection of ctDNA for MRD as a biomarker, it is possible for adjuvant clinical trials to be conducted in smaller and more relevant settings by only escalating therapy in patients who are set to relapse, thereby potentially reducing trial size, cost and time. The full results of the analysis will now be presented today at 2:30 p.m. ET during the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting (abstract #2025).ⁱ

"Specificity is a critical and under-appreciated requisite of frequent disease monitoring," said Christopher Abbosh, M.D., Principal Clinical Fellow, UCL. "Data from a 50-variant version of the research assay demonstrates a variant detection limit of 0.003% at high cfDNA input levels while maintaining 100% variant analytical specificity. Together, with our collaborators, we aim to establish an MRD approach to treating early-stage NSCLC in order to determine which patients are likely to relapse and overcome challenges associated with conventional adjuvant therapy trial design. We believe this approach will provide an opportunity to expand precision oncology into early-stage cancer, when the cancer is typically easier to cure."

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 Archer's proprietary Anchored Multiplex PCR (AMP™) technology to accurately detect exceedingly low levels of cancer-derived DNA from patient blood.

"There remains a stark unmet need to improve the current adjuvant standard of care and outcomes in patients with solid tumors," said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. "Key to reducing patient burden in cancer treatment is a minimally invasive assay that enables tracking disease recurrence at the earliest possible time point directly at the patient's care setting. We are thrilled to collaborate with the UCL team, which aligns closely with ArcherDX's mission to bring the right test to the right patient at the right time."

Lung cancer is one of the most common types of cancer worldwide and a leading cause of cancer-related death.ⁱⁱ NSCLC is the most common type of lung cancerⁱⁱⁱ and has a complex genomic landscape.^iv

About TRACERx Study
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 analysing 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.

About ArcherDX
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.

About UCL – London's Global University
UCL is a diverse community with the freedom to challenge and think differently.

Our community of more than 41,500 students from 150 countries and over 12,500 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems.

We are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact.

We have a progressive and integrated approach to our teaching and research – championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors.  

For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge.

We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL.

www.ucl.ac.uk | Follow @uclnews on Twitter | Watch our YouTube channel | Listen to UCL podcasts on SoundCloud | Find out what's on at UCL Minds | #MadeAtUCL

About The Francis Crick Institute
The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases.

An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King's College London.

The Crick was formed in 2015, and in 2016 it moved into a brand new state-of-the-art building in central London which brings together 1500 scientists and support staff working collaboratively across disciplines, making it the biggest biomedical research facility under a single roof in Europe.  http://crick.ac.uk/

About Cancer Research UK
Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research. Cancer Research UK's pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public. Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.

Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK's ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years. Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.

Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured. For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

Forward-Looking Statements
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 "aim," "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 the impact of the collaboration with UCL, the goal to establish and the expected impact of the MRD approach to treating early-stage NSCLC on precision oncology. 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.

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