Oncimmune Holdings (ONC ) informed investors that it has agreed to take back the rights of its EarlyCDT® technology in the People's Republic of China (PRC) and Hong Kong (HK). 

The global immunodiagnostics group said this latest agreement to acquire the intellectual property (IP) and distribution rights for the EarlyCDT® technology across both China and Hong Kong will grant the business with strategic options to enter the US capital markets.  

Oncimmune granted Genostics, a Hong Kong diagnostics firm, the exclusive rights to EarlyCDT products in China and Hong Kong in January 2018. To date, the two parties have developed a lung panel ‘with superior performance’ in Greater China and Asia-Pacific, given the prevalence of EGFR-positive non-small cell lung cancer (NSCLC) in the region, it noted. 

As previously announced back in May 2019, an Asia-specific lung panel which has been used in a multi-centre study as part of this partnership, is now due to complete in China in 1H21.  

Data from this study is intended to be used to support approval by the China National Medical Products Administration for the use of the Asia-specific lung cancer test in the PRC. 

Under the agreement announced today, all material, IP, data, and goodwill will be transferred back to the Company, and Oncimmune will be paid in full for the royalties due in January 2021 under the existing Technology Licencing Agreement.  

Oncimmune said it has also agreed to pay a fixed amount for the return of the IP and distribution rights, with the majority of the value of the consideration being conditional on fixed future events. 

 "We are grateful for the collaboration with Genostics and its parent company, Gene Group Holdings Ltd, over the past three years and are pleased with the progress that has been made with our Asia-specific lung panel,” said Dr Adam M Hill, CEO of Oncimmune. 

“However, as both companies consider their future on different equity capital markets, the continuing success of the EarlyCDT product portfolio, both in and outside of PRC and HK, requires Oncimmune to own the IP and distribution rights,” Hill explained to investors. 

With accelerating growth of Oncimmune's ImmunoINSIGHTS business, the Company said it intends to explore options available to it to access the US capital markets in the near term. 

The Company highlighted to investors that the termination of its partnership with Genostics and return of the EarlyCDT product rights to the PRC and HK markets provides Oncimmune with ‘further strategic optionality which could support a path to the US capital markets.’ 

As part of the agreement, and as previously announced, Genostics has agreed to a lock-in of its remaining shareholding in Oncimmune (currently 4.73 per cent. of the issued share capital) for a period of 12 months from 6 May 2021, except under certain limited exceptions. 

“We are delighted that Genostics has agreed to continue to participate in Oncimmune's success as a shareholder, and Oncimmune looks forward to progressing its market access plans imminently,” added Hill.  

View from Vox 

Ok, but why is this good news? Well simply because I think there maybe a much better way to commercialise #ONC's terrific lung cancer technology (98% specificity - branded nodifycdt in US) ). That being to combine it with Biodesix, Inc.'s equally high performance blood draw test (97% sensitivity - branded nodifyxl2). 

Together these 2 top quality liquid biopsy screens (see charts) provide an excellent, well balanced and highly accurate early diagnosis for GPs & clinicians of patients with possible non-small cell lung cancer.  

A deadly disease that is very difficult to successfully treat, if identified in advanced or late stage cases.  

Elsewhere #ONC also said it was exploring options to potentially soon raise money on the US capital markets. Obviously if this occurs, then a US listing could provide a major boost (re-rating) to the shares. 

Shares in Oncimmune have increased by nearly 40% in value since the beginning of 2021. The stock was trading 4.62% lower this morning at 227p following the announcement. 

Reasons to ONC

Oncimmune Holdings’ focus is to harness the immune system’s sophisticated response to disease to detect cancer earlier and to support the development of better therapies. 

Leading Proprietary Technology Portfolio 

The company believes the key to improving cancer survival is early detection and optimal selection for therapy. Oncimmune's immuno-diagnostic test, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. 

Oncimmune’s core technology also powers its ImmunoINSIGHTS service; a proprietary platform that enables life-science organisations to optimise drug development and delivery, leading to more effective, targeted as well as safer treatments for patients. 

The group’s EarlyCDT Lung blood test was previously featured on an ITV news broadcast last weekend titled ‘New Blood Test Provides Breakthrough in Lung Cancer Detection Rates’.  

The feature highlighted that, in the UK, more than 35,000 people die of lung cancer each year and most have their lung cancer diagnosed late thereby lowering their chances of survival. 80% of lung cancer cases are diagnosed in the latest stages of the disease.  

The EarlyCDT test works to identify the immune system's response to the presence of lung cancer. The test detects antibodies present in the body, enabling clinicians to focus their diagnosis on identifying the disease and treating it earlier than current clinical practice.  

It has previously been shown that Oncimmune’s EarlyCDT Lung blood test can detect lung cancer on average four years before standard of care and has shown in a large National Health Service (NHS) trial that it can reduce late stage lung cancer presentation by 36%. 

Inflection Point to Commercialisation 

The Company now believes it has made the point of inflection as it matures from an R&D business into a commercial entity evidenced through its deepening commercial relationships with Industry Partners such as Roche 

Fully Funded 

The Company is now fully funded to develop all its commercial activities and drive revenues. 

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