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Odour-GPCRs based technology for detection and stratification of cancer: Prostate Cancer Smell Print as first vertical market

Periodic Reporting for period 1 - PCSP (Odour-GPCRs based technology for detection and stratification of cancer: Prostate Cancer Smell Print as first vertical market)

Reporting period: 2015-05-01 to 2015-10-31

PCSP Project is born out of the unique expertise developed after years of R&D at Canvax Biotech, and aims at transferring a technology to cover an unmet clinical need, accurate diagnosis of prostate cancer. Prostate Cancer Smell Print (PCSP) main objective consists on the validation and commercialization of a novel, easy-to-use, non-invasive, cost-effective, highly sensible and robust technology to increase PCa diagnosis accuracy, stratification and discrimination of aggressive tumours.
In the feasibility study a complete business plan will be elaborated attending to the following specific objectives:
a. Final definition of PC Smell Print prototype and data analysis.
b. Study together with experts the regulatory path for approval and acceptance by health system.
c. Design a large clinical trial (with clinicians and regulatory agencies) to test the prototype.
d. Deeper market segmentation research.
e. Addressing the needs to acquire market permits (CE Mark, license for production, etc).
f. Optimization of business and commercialization model (Private vs public Health System).
g. Model of analytical laboratories (Owned vs partnering) and expansion towards EU.
h. Final estimation of costs to conform the financial plan.
The work performed during the feasibility study has allowed to complete our business plan and has helped us to elaborate a plan for developing our technology and clarified the path towards commercialization.

Canvax has set up a PC Smell Print prototype obtaining encouraging preliminary results in samples from Prostate cancer patients. Canvax has consulted with experts including, physicians, the Spanish National agency of medicaments (AEMPs), experts from the Evaluation of Technology Assessment (AETS), and consultant firms. From this consultation Canvax has clarified its first vertical (Prostate Cancer) and analysed comparatively with other proposed markets.

Also, Canvax has now a clarified view of the type of clinical trials and the endpoints needed so the product can get faster and easier to the market, which will always go through the acceptance by the appropriate agencies, CE mark, evaluation by the technology assessment agency (AETS) and approval for incorporation into the national health system based on the usefulness of the technology. Canvax has established a list of priorities on the needs that could be solved by the type of diagnostic assay under development and that could be of high utility by the health sector helping discriminate better the populations with different Prostate care needs and different grades of Prostate cancer.

The market segmentation study has been done by personal interviews with urologists, oncologists and primary care physicians. We have obtained a clear market segmentation based on the different types of cancers and based on the needs of public health care and private markets. This market segmentation has helped us define the needs and endpoints to be measured during the preliminary clinical trial currently on-going.
Business and commercialization models have been deeply study to finally conform a financial plan that would help translate this technology to the market.
The PCSP Project has identified the best path for development of a future clinical trial that would result in the development of a novel methodology to diagnose Prostate Cancer. The benefit to the society has been focus evaluating the needs of the public health care, including clinicians and patients views, and considering the economic impact over the health system.

The main result is the identification of novel biomarkers and their utility in the clinic, which allows the project to continue through a SME phase II that will be basically dedicated to the development of the final clinical trial that would allow us to acquire all the scientific and medical data needed for the test to be accepted by health care providers and to get all necessary permits complying with all required regulatory aspects.
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