Oncimmune and Biodesix Form Strategic Partnership to Unlock Full Potential of EarlyCDT Lung in US

Pharmaceutical

A leading global immunodiagnostics group, has announced it has entered into an exclusive partnership agreement which it believes will unlock the full potential of EarlyCDT® Lung in the United States, bringing this lung cancer test to more patients as a result. This agreement with Biodesix, Inc., a leading lung cancer diagnostic solutions company, encompasses both the commercialisation by Biodesix of EarlyCDT Lung, as well as the supply by Oncimmune of the EarlyCDT Lung product. The agreement also involves the sale of Oncimmune’s US subsidiary’s operations including the CLIA laboratory. Over the next five years this agreement represents value to Oncimmune of up to $28 million.

The agreement will accelerate the organic growth of EarlyCDT Lung, Oncimmune’s lead product, in the largest lung cancer market in the world. In 2019, it is estimated that there will be 228,150 new cases of lung and bronchus cancer in the US alone [1]. Late stage detection of lung cancer has a 5-year survival rate of 5%, which increases to approximately 57% if the tumour is found early while still localised [1]. EarlyCDT Lung helps clinicians assess malignancy risk in patients presenting with indeterminate pulmonary nodules (IPNs) with the aim of improving patient outcomes through earlier intervention.

“Oncimmune has announced it has entered into an exclusive partnership agreement with Biodesix, which it believes will unlock the full potential of EarlyCDT® Lung in the United States. “

In addition to use in lung nodules, Oncimmune has also granted Biodesix the opportunity to further capitalise on the commercial potential for EarlyCDT Lung as a screening indication in the US. Following Oncimmune’s announcement on 4 June 2019 that the Early Cancer Detection Test – Lung Cancer Scotland Study (ECLS) had met its primary end-point, it is Oncimmune’s belief that the potential screening indication opportunity increases substantially the total market for EarlyCDT Lung in the US and beyond.

Oncimmune will also collaborate with Biodesix on research and development activities in order to fully leverage EarlyCDT Lung both in the US and other major lung cancer markets.

Dr Adam M Hill, CEO of Oncimmune commented: “In October 2018, I undertook to establish a strategic commercial partnership that fully realises the value of EarlyCDT Lung in the US, not only delivering revenue growth but ultimately helping improve patient outcomes through earlier diagnosis and intervention. I believe in Biodesix we have found an excellent partner. Like us, Biodesix is committed to delivering solutions that span the continuum of care, but importantly, focuses exclusively on lung cancer. This agreement is designed to accelerate access for EarlyCDT Lung into the US market and creates a compelling new commercial partnership in lung cancer management.

“We are proud to be working with Biodesix, a company with a successful track record of commercialising three clinical diagnostic lung tests in the US.”

David Brunel, CEO of Biodesix commented: “By integrating both genomic and proteomic technologies, Biodesix is focused on enabling clinicians involved in nodule management and those treating lung cancer to improve patient management and patient outcomes while reducing unnecessary procedures and related side effects, while reducing costs. This partnership with Oncimmune, a global leader in autoantibody science, further strengthens our position as the leading lung cancer diagnostic solutions company in the US and initiates a collaboration to fully exploit the potential of EarlyCDT Lung in the US. The addition of EarlyCDT Lung to our portfolio completes our comprehensive solution for all patients with indeterminate lung nodules.”

About Oncimmune

Beating cancer, one test at a time

Oncimmune is a leader in the development, manufacture and commercialisation of cancer specific immunodiagnostics for the screening, detection and care of cancer. Oncimmune also develops precision medicine and patient stratification tools for leading pharmaceutical multinationals in both autoimmune disease and immuno-oncology. Oncimmune is working to change how cancer is diagnosed and treated. Its patented technology detects evidence of the body's natural response to cancer, enabling detection four years or more before standard clinical diagnosis. Oncimmune’s tests facilitate clinical decision-making and are complementary to diagnostic technologies, making them valuable additions to established and new care pathways. Oncimmune partners with leading developers and distributors to make our technology available globally.

Oncimmune was founded in 2002 and launched its platform technology in 2009, followed by its first commercial tests, EarlyCDT Lung and EarlyCDT® Liver. To date, over 155,000 tests have been performed for patients worldwide. EarlyCDT Lung was also used in what is believed to be the largest randomised controlled study for the early detection of lung cancer using biomarkers, the National Health Service (NHS) ECLS study of 12,210 high-risk smokers in Scotland. The study met its primary end-point - showing that the use of EarlyCDT Lung with subsequent X-ray and computerised tomography (CT) scan reduced the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis, compared to standard clinical practice.

Oncimmune, headquartered at its laboratory facility in Nottingham, UK, has a discovery research centre in Dortmund, Germany and a CLIA lab in Kansas, US as well as offices in London, UK and a representative office in Shanghai, China. Oncimmune joined the Alternative Investment Market (AIM) of the London Stock Exchange in May 2016 under the ticker ONC.L.

What is EarlyCDT Lung?

A blood test using a panel of seven immunogenic proteins for the testing of tumour-related antibodies specific to lung cancer.

For more information, visit www.oncimmune.com.

About Biodesix

Biodesix is a lung cancer diagnostic solutions company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence. Biodesix is the first company to offer three best-in class tests for patients with lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies. The Biodesix Lung Reflex® strategy integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours. The Nodify XL2™ nodule test, which will be commercially available in the second half of 2019, evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.

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