Periodic Reporting for period 2 - FGFSTAB (Industrial Production of Stable Fibroblast Growth Factors for Regenerative Medicine and Related Research Areas)
Reporting period: 2018-03-01 to 2019-02-28
The main goal of the FGFSTAB project was to address the poor stability of selected members from the fibroblast growth factor family (FGFs) and thus increase their chances of commercial success (mainly in the therapeutic area). FGFs are essential to embryonic development, maintaining tissue homeostasis, and may slow down the ageing of organisms, and primarily promote angiogenesis and wound healing. FGFs’ greatest application can be found in the care and treatment of chronic skin ulcers, but are also used in surgical and traumatic wound healing. The global wound care market is rapidly growing due to the rising ageing population and growing incidences of obesity and diabetes. Advanced wound dressings, such as those involving growth factors, play an important role in the current regenerative medicine. Growth factor-based products are on the rise. Despite their clinical value, applications of FGFs are limited by the fact that natural proteins have poor thermal stability. They are often cleared from the body within hours, if not minutes, thus necessitating frequent administrations during the course of treatment. That goes hand in hand with a higher risk of adverse effects and lower cost-effectiveness of the protein therapy. The key objective of this project is to apply Enantis proprietary protein engineering concept to increase FGF stability under various stress conditions. And to conduct detail, both in vitro and in vivo, testing of stable proteins. Additional challenges include lowering the cost of production, implementing Good Manufacturing Practices, and developing delivery systems for safe and effective wound healing.
The work in the FGFSTAB project was divided into six work packages, plus one additional work package on ethics requirements. Over the 1st reporting period, the work in the FGFSTAB project has started in all work packages and Enantis submitted 19 deliverables, including 7 additional deliverables on ethics as described in the 1st periodic report. In the 2nd year of the project, 10 deliverables have been submitted to the European Commission.
In summary, two members of the FGF family, FGF7 and FGF10, were successfully stabilized and characterized. Both proteins have been shifted from the development phase to the commercialization phase. Big progress has been made to make Enantis an expert in recombinant production of FGF proteins. The combination of high stability with a cost-effective manufacturing process significantly increases the practical applicability of these proteins. Moreover, the possibilities for GMP-compliant and cost-effective production of FGF2-STAB were carefully considered. Various FGF2-STAB formulations have been developed. The FGF2-STAB-enriched scaffolds were evaluated in vivo using animal models of chronic wounds. Besides that, activities in the project were dedicated also to in vitro testing of efficacy and safety of FGF2-STAB, including, for example, determination of cytotoxicity, FGF2-STAB-induced mRNA expression of selected wound healing markers and scratch assay mimicking the wound healing process. Furthermore, Enantis was intensively engaged in dissemination and commercial exploitation of the project’s results. The dissemination was done through several channels, such as the company’s website, social media (Twitter, LinkedIn), newsletters and active participation at international events (seminars, workshops, conferences, trade fairs). Several exploitable results for further commercialization have been achieved in the course of the FGFSTAB project. The main benefits for Enantis include new knowledge, increase of market share, increase of revenues, and cost savings.
In summary, two members of the FGF family, FGF7 and FGF10, were successfully stabilized and characterized. Both proteins have been shifted from the development phase to the commercialization phase. Big progress has been made to make Enantis an expert in recombinant production of FGF proteins. The combination of high stability with a cost-effective manufacturing process significantly increases the practical applicability of these proteins. Moreover, the possibilities for GMP-compliant and cost-effective production of FGF2-STAB were carefully considered. Various FGF2-STAB formulations have been developed. The FGF2-STAB-enriched scaffolds were evaluated in vivo using animal models of chronic wounds. Besides that, activities in the project were dedicated also to in vitro testing of efficacy and safety of FGF2-STAB, including, for example, determination of cytotoxicity, FGF2-STAB-induced mRNA expression of selected wound healing markers and scratch assay mimicking the wound healing process. Furthermore, Enantis was intensively engaged in dissemination and commercial exploitation of the project’s results. The dissemination was done through several channels, such as the company’s website, social media (Twitter, LinkedIn), newsletters and active participation at international events (seminars, workshops, conferences, trade fairs). Several exploitable results for further commercialization have been achieved in the course of the FGFSTAB project. The main benefits for Enantis include new knowledge, increase of market share, increase of revenues, and cost savings.
During the FGFSTAB project, Enantis has strengthened its presence in two operating segments: (i) protein engineering service and (ii) engineering of therapeutic proteins. Particular emphasis was put on recombinant stabilized FGFs for their increasing popularity in improving the healing of chronic wounds and other areas. Within FGFSTAB, we were working on facilitating the usage of our stabilized FGFs not only by end users but also from the perspective of service providers and manufacturers. This greatly increases Enantis chances to enter the lucrative pharmaceutical market.
The FGFSTAB project brings not only economic benefits for Enantis but also social ones. It can ensure a better quality of life to patients and a more efficient healthcare organization within European countries. According to a recent article from Nature Biotechnology titled “Wanted: biotech for an ageing population”, the over-60s represent one in eight people today, but they will be one in five by 2050 (around 2 billion people). Obviously, the burden of age-related diseases increases concomitantly; more than 70% of people over 65 suffer from two or more chronic conditions which place a growing and substantial pressure on healthcare budgets. Several recent studies show that approximately 1–2% of the population of the EU is affected by chronic wounds, requiring a financial commitment of 2–4% of total health budgets from governments and an average of 6000–10,000 EUR per patient per annum. In this scenario just rely on the actual state-of-the-art treatments is simply unrealistic.
In the course of the project, Enantis created 9 new job positions of which 6 in the R&D unit and 3 in the management and administration. We have also successfully attracted people from abroad which allowed us to embed in our organization knowledge and experience from different cultural environment, and this ultimately boosts the development of a very collaborative working place.
The FGFSTAB project brings not only economic benefits for Enantis but also social ones. It can ensure a better quality of life to patients and a more efficient healthcare organization within European countries. According to a recent article from Nature Biotechnology titled “Wanted: biotech for an ageing population”, the over-60s represent one in eight people today, but they will be one in five by 2050 (around 2 billion people). Obviously, the burden of age-related diseases increases concomitantly; more than 70% of people over 65 suffer from two or more chronic conditions which place a growing and substantial pressure on healthcare budgets. Several recent studies show that approximately 1–2% of the population of the EU is affected by chronic wounds, requiring a financial commitment of 2–4% of total health budgets from governments and an average of 6000–10,000 EUR per patient per annum. In this scenario just rely on the actual state-of-the-art treatments is simply unrealistic.
In the course of the project, Enantis created 9 new job positions of which 6 in the R&D unit and 3 in the management and administration. We have also successfully attracted people from abroad which allowed us to embed in our organization knowledge and experience from different cultural environment, and this ultimately boosts the development of a very collaborative working place.