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Industrial Production of Stable Fibroblast Growth Factors for Broad Therapeutic, Research, and Personal Care Applications

Periodic Reporting for period 1 - FGFSTAB (Industrial Production of Stable Fibroblast Growth Factors for Broad Therapeutic, Research, and Personal Care Applications)

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

Enantis, a biotechnology company working in the field of protein engineering and enzyme technologies, was founded in 2006 as the first biotech spin-off of the Masaryk University in Brno (Czech Republic). The company has proprietary protein stabilization technology which is proving to be a significant platform for launching innovative product lines addressing a global societal and economic trends. Following this ambition, Enantis has identified stabilization of fibroblast growth factors (FGFs), their industrial production and commercialization as one of high priority areas with good business opportunities. FGFSTAB project bridges the gap between Enantis's knowledge and expertise on protein engineering and the practical application of stable FGFs. FGFs are fundamental in the processes of proliferation and differentiation of wide variety of cells and tissues. Various FGFs are currently being tested therapeutically for use in cancer treatment, regenerative medicine, and a number of age-related disorders, including cardiovascular diseases and diabetes. Effects important for cosmetic applications includes rejuvenation of the epidermal cells and the underlying fibroblast cells, production of collagen, and hair growth support. FGF2 is an essential component of media for human pluripotent stem cells cultivation. However, the practical applications of FGF proteins are severely limited by the fact that natural proteins have intrinsically poor thermal stability. The objectives of FGFSTAB project are to use Enantis's proprietary protein stabilization technology to increase FGF stability under various stress conditions and to develop a process for producing stable FGFs at a large scale and low cost.
The main purpose of the Feasibility Study elaborated during the reporting period was to define possible usage scenarios of stabilized FGFs on the existing markets and suggest new markets and applications to expand the company's business. The direct outcome of the Feasibility Study is a company strategy for the commercialization of stable FGFs. Whether it is the ageing population, soaring obesity rates, or the more active population, the demand for advanced protein products has never been higher. The global market for protein therapeutics is expected to increase to nearly EUR 130 billion by 2020. Using advanced protein production technologies to manufacture improved FGFs cost effectively, Enantis will provide the end users on healthcare, cosmetic and stem cell research markets with the best value per money.The competitive advantages of the FGF2 STAB product were confirmed by several stem cell laboratories that received free samples for independent testing. The proprietary FGF2 STAB product shows stable and preserved biological activity for longer than 5 days at 37°C, which is far above FGF2 variants available on the market. Potential customers also confirmed higher versatility of product which can be applied in research as well as in clinical practice. Our FGFs have considerable potential as cosmetic ingredients, therapeutic agents as well as stable components of media for culturing stem cells. From a business point of view, the FGFSTAB project will enable Enantis access to new high-value markets addressing global societal challenges. Thanks to the universality of the stabilization technology, Enantis plans to accomplish sustainable growth by continuing the development of stabilized proteins and introducing 1-2 new industrially attractive molecules every year.
Our ambition in the FGFSTAB project is to create 5 new job positions and significantly increase the company income over a two-year period. The financing of the next development phase of the FGFSTAB project is expected to lead to the following anticipated benefits: i) the proposed therapeutic approaches using FGFs and/or stem cells will contribute to promoting healthy living and active ageing, which represents a societal challenge common to all EU countries and is an integral part of the Europe 2020 Strategy, ii) novel cosmetic products, addressing problems of oral cavity diseases and anti-aging challenges will improve living standards and the economic outcomes of the EU, and iii) realizing the FGFSTAB project will lead to the economic benefits achieved by strengthening the export potential of high-added value products outside the Czech Republic and outside the Europe.
Content of the Feasibility study FGFSTAB