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Nanofiber based drug delivery for surgical therapy of adult and paediatric solid tumours

Periodic Reporting for period 1 - RELEASE (Nanofiber based drug delivery for surgical therapy of adult and paediatric solid tumours)

Reporting period: 2017-02-01 to 2017-07-31

The technology developed by Cebiotex in collaboration with academic institutions is a local drug delivery system based on polymeric fibres. Owned platform technology can be applied in multiples medical applications where a local active compound release is clearly beneficial for patient outcome. When an oncological surgeon removes a cancer tumour, there is a medical need to ensure the surgical site is free from cancer cells. During 3-4 weeks after the procedure neither radiotherapy, nor chemotherapy treatments can be applied in order to allow for scarring of the wound. These 3-4 weeks are crucial because, if cancer cells are left, they can reproduce quickly, re-growing the tumour, which may later be hard to contain with radio or chemotherapy Cebiotex nano fibre material allows for highly targeted delivery of the drug. Following surgical removal of resectable tumours, we are targeting the application of our nano-material embedded with a strong antitumoral drug to the bed of the wound. In this way, we carry out sustained delivery of the drug directly at the surgical site during the post operation period when cancer re-growth can occur. Moreover, we avoid blood delivery of the drug avoiding the wide spread toxic effects that this would otherwise generate. Cebiotex technology is initially focused to drug development in the oncology field. However, the same concept will apply to develop novel medical products with other applications as is detailed in the Feasibility Study (confidential information). So, the business strategy of the company is oriented to develop our Business Model based in 2 different product lines, one of them addressed to the oncology market and clients and the other one we have to kept confidential at this stage of development.
These products are important for the current cancer treatment standards because they focus on a non-covered period between tumour resection and subsequent chemotherapy and/or radiotherapy, where the technology of Cebiotex can help to reduce or even stop tumoral cells growth. Therefore, the expected impact for the society is a noticeable higher success expectations in the treatment of the target cancer types.

The overall objectives of the project have been:
- Create a thorough business plan for creating a Nano-tech drug delivery company
- Ensure wide European interest for our company & initial solution within the target sectors and Specialist Hospitals
- Fully understand requirements for moving the first product of the company to and through PHASE 1 (Human) medical trials
The work carried out can be summarised in four points:

- Progress in laboratory, preclinical tests and technology performance improvement for the product pipeline
- Contact with several medical experts in the oncology and hospital sector in EU and US to arise interest in the sector and obtain feedback from the relevant actors across EU and US, resulting in the definition of the Scientific Advisory Board of the Company and additional support with Letters of Interest
- Analyse initial and direct feedback from Cebiotex’s potential clients (Pharmaceutical Industry and Venture Capital Firms) by attending to main Pharma events in EU and US.
- Cebiotex business model was studied in order to define the best strategy to follow. This included analysis of the business plan, IPR, commercial approach, market impact and organization of the company to face the challenge
During the project execution, the Company has continued working on the regulatory path of its first product, obtaining highly promising results in its current stage. The potential impact for the first product pipeline coming out of Cebiotex's technological platform is aimed at those tumours in which local control of resectable cancers post-surgery is necessary to improve prognosis; This represents over 1Million cancer cases per year that can be treated by the Cebiotex product pipeline. Within these, CEB-01 aimed to be our first therapeutical application, targeting adult soft tissue sarcoma (STS); with 40.000 new cases/year (13.000 deaths/year) in the EU and the USA , and a potential addressable market of 257 million euros; new products studied within the project cover health problems affecting 197M people worldwide, thus with an huge in both social and economic aspects. These products have been now included in the Cebiotex product pipeline.
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