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Strategic planning for commercialisation of a multiplexed protein diagnostic (Dx) blood test for Organ-Confined Prostate cancer: OCProDx

Periodic Reporting for period 1 - OCProDx (Strategic planning for commercialisation of a multiplexed protein diagnostic (Dx) blood test for Organ-Confined Prostate cancer: OCProDx)

Reporting period: 2016-01-01 to 2016-06-30

Atturos is an exciting new clinical diagnostics company with the goal to deliver diagnostic tests and services of global impact. Our vision and intent is to apply integrity and energy to innovative product development that address areas of clinical unmet need. Atturos' initial product, OCProDx, is the first in a pipeline of new tests aimed at providing valuable information to support better decision making between patients and clinicians. Atturos tests will improve the health and quality of life of patients while also increasing the cost-effectiveness of healthcare systems

The OCProDx test has been developed for men with prostate cancer and uses clinically compatible mass spectrometry technology to measure multiple proteins from a small blood (serum) sample. The protein measurements are combined using a proprietary algorithm to give a robust ‘Organ Confinement Score’. This score is the probability with which the tumour has spread beyond the prostate gland. By provinding this information OCProDx meets a key unmet clinical need as identified and outlined in recent clinical guidance from the National Institute for Health cna Care Excellent (NICE, UK), the European Association of Urology (EAU) and guidelines of the American Urological Association (AUA). Knowing the probability with which the tumour confined to the prostate has the potential to influence the timing and choice of treatment for men with prostate cancer and so have a profound impact on their quality of life.

In Europe, 1 in 7 men will be diagnosed with prostate cancer and the currently equates to over 400,000 men each year. Well over half of these newly diagnosed men are classified as having low to intermediate risk disease. The equivalent figures in the US are >250,000/year and globally >1.2M/year. The majority of these men will not die from prostate cancer and would benefit from active surveillance, which is the monitoring of disease progression, before for treatment intervention should it ever become necessary. At present, most newly diagnosed men are treated with surgery, radiation or chemotherapy largely because existing diagnostic tools do not adequately support the active surveillance versus treatment decision. This over-treatment of men with prostate cancer is a now widely acknowledged and serious issue: the side effects of treatment are often worse than the disease itself and they often impact very negatively on quality of life. For men on active surveillance existing biopsy based tests do not adequately support long-term repeated monitoring. In summary, OCProDx provides a minimally invasive test to provide information for men with prostate cancer to assist with the decision of whether to go on active surveillance and for those on active surveillance whether to remain so.
The key objective of this H2020 pilot phase feasibility study was to undertake comprehensive product and market analysis and to prepare a detailed investor-ready business plan for Atturos. Specific objectives were to:
i. Undertake a comprehensive analysis of the OCProDx product offering to include competitor analysis, product positioning, commercial opportunities and key risks
ii. Evaluate the core patent supporting OCProDx and develop a patent strategy for pipeline tests
iii. Identify key regulatory considerations for the introduction of OCProDx and an Atturos clinical diagnostic laboratory
iv. Engage with key stakeholders including patients, end users, and Key Opinon Leaders (KOLs) to evaluate their opinions on OCProDx
v. Gather detailed background information to identify potential routes to market
vi. Develop robust financial projections and planning
vii. Build a strategy for engagement with KOLs for delivery of the test to end users
The overall goal was to capture this project-driven 'strategic intelligence' in a detailed investor-ready business plan. This business plan has now been prepared and will be used to obtain investment in Atturos to drive the development and monetisation of the OCProDx test.
This 6 month project was initiated on Jan 1st 2016 and all members of the Atturos team have been actively engaged to produce the single deliverable of an investor-ready business plan for Atturos. To achieve this the team have undertaken extensive gathering, documentation and assessement of 'strategic intelligence' and have participated in on-going dissemination of the project to obtain important stakeholder feedback. This work has included:

i. Attendance at key end user (clinician and urologist) orientated meetings and conferences, to evaluate their views on current treatment and diagnostic procedures including OCProDx. These meetings included the European School of Oncology meeting on Active Surveillance (Milan, Italy; February 2016), the European Association of Urology Annual meeting (Munich, Germany; March 2016) and the 2nd Annual John Fitzpatrick Symposium (Dublin, Ireland: April 2016). For the latter, the team produced a meeting report that will appear in the July 2016 issue of 'Oncology Reports'.
ii. Continued dissemination of information on the OCProDx test and Atturos by speaking (Invited) and chairing sessions at several significant national and international meetings. These included Oxford Global's 11th Annual Biomarkers Congress (Manchester, UK; February 2016); Catholic University Hospital (Rome, Italy; February 2016), GTC's Biomarker Summit 2016 (San Diego, CA; March 2016,); an Open Innovation Conference (Limerick, Ireland; June 2016) and the 64th American Society for Mass Spectrometry (San Antonio, USA; June 2016). At these events the OCProDx test received significant positive feedback and a number of additional key clinical and commercial contacts have been established. Furthermore, this exposure has resulted in at least 5 further invitations to speak at conferences and clinical centres in Europe, the US and Asia.
iii. The Chairman and Founder of Atturos have held multiple 'one to one' meetings with industry experts, representatives of government agencies and local investors. Two investors have approached Atturos and several exploratory meetings have been held which will now be supported by the business plan prepared during this project.
iv. Atturos hosted three significant brainstorming sessions in May 2016 – clinical, technical, and business development themed. These day long sessions were held in UCD’s research and innovation hub – NovaUCD – and chaired by an experienced and inspirational partner in Frost & Sullivan. The sessions attracted significant exposure for Atturos and OCProDx. The clinical, technical, and business development sessions were attended by scientists (industry, research, and hospital-based), clinicians, patients, entrepreneurs, and a number of KOLs and influencers from industry and academia. During the sessions a number of key questions were presented to groups and, through facilitated breakout sessions, potential solutions and ideas were gathered. The extensive information from these sessions has been thoroughly recorded and documented, and has served as a hugely valuable resource for Atturos’ continued development. Some of the recommendations arising from the sessions have been implemented already, with further experiments and planning already underway. Key strategic guidance has been incorporated into our plans and major elements are represented in the business plan. The team have prepared a 'Frequently Asked Questions' document addressing these matters and consolidating answers that will be presented to investors as required. Within Atturos the Brainstorming sessions have led to engagement with important stakeholders who have commited to the continued development of the company.
v. Production of an online market research survey and its pilot completion by ten US urologists (survey conducted in partnership with Qualtrics). The results of this survey have been highly informative and encouraging, and elements from this have been incorporated into the business plan.
vi. Development of key interactions with local accredited testing laboratories and visits by the team to hospital, commercial and forensic laboratories. This included a multinational CRO with laboratories that provide testing for clinical trials. These interactions will support the efficient and streamlined development and implementation of an Atturos accredited laboratory.
vii. Engagement in EU supported business mentoring sessions with a highly experienced and enthusiastic mentor whose advice and guidance will play a key element in shaping our strategic plans to build value in OCProDx and Atturos.
viii. Implementation of the website for Atturos ( which will be updated continuously as the company grows.
ix. Use of Enterprise Ireland facilitated access to multiple key industry reports to gather strategic intelligence on current diagnostics market trends in Europe and worldwide.
x. Preparation of an IP strategy that has provided an outline of the steps required for protection of the Atturos clinical methods and products. A patent landscape report, completed by a major UK patent firm, has confirmed FTO for OCProDx.
xi. Preparation of a publication strategy to ensure the scientific evidence underlying the OCProDx test development and performance is disseminated. Several scientific manuscripts have been prepared and some now accepted with a pipeline of others under review.
xii. Development and on-going consolidation of an investor information pack containing the up-to-date business plan, FAQs, lab process information (SOPs) and data.
xiii. Team building workshops with the Atturos leadership team have strengthened our relationships and re-inforced our motivation to continue working on this venture with vigour.

This work has been invaluable and we are confident it will support significant investment in Atturos to drive company growth, employment and delivery of the first of a pipeline of products that will have significant healthcare impact.
The response to OCProDx and Atturos at international meetings and conferences, our brainstorming sessions, and investor meetings has been overwhelmingly postive. The reaction of KOLs and industry leaders to the Atturos R&D approach has led to numerous discussions and paved the way for on-going beneficial interactions in the future.

During the clinical and technical brainstorming sessions we had the privilege of having two prominent prostate cancer patient advocates in attendance. One of the patients is currently Secretary of the European Prostate Cancer Patient advocate group (Europa-UOMO) and the other Chairman of the Irish male cancer patient advocate group 'MAC: Men Against Cancer'. Both are retired businessmen of considerable commercial experience and they provided a unique insight of the realities of living with the disease. Their input into the discussions around the positioning of the test, reporting of results in an accessible manner, development of supporting information, and pricing/re-imbursement was hugely significant, and had an impact on everyone in attendance. Their unique and invaluable contribution also helped the team to refine the ethos and culture of Atturos. We will ensure patients are actively engaged in the continued development of the business and that the interests of the patients is central to what Atturos does.

The brainstorming sessions also had an influence on those who attended and their success has led Frost & Sullivan to consider implementing similar events into their SME supports. NovaUCD will incorporate the concept into the University's innovation guidance and training programmes.

We made significantly more progress than anticipated in the level of market research and competitor analysis we were able to undertake. We have now developed an extensive database of over 20 commercially developed diagnostic tests for prostate cancer, have extensive information on the organisations responsible for their development and a full database of the underlying IP including copies of every relevant patent. This research was facilitated by multiple focused fact finding visits to the information resources available in Enterprise Ireland, Dublin and has confirmed our conclusion that OCProDx is the only blood-based (biopsy independent) diagnostic test that provides information on a key biological property of prostate cancer which may correlate with the metastatic potential of the disease.

The progress made on the project has re-inforced our recognition of the huge potential impact OCProDx will have by helping men with prostate cancer and their physicians make better decisions.