Periodic Reporting for period 1 - Marigold (Enhancing the lutein content of Marigold) Reporting period: 2015-07-01 to 2015-12-31 Summary of the context and overall objectives of the project Hudson River Biotechnology (HRB) aims to disrupt the global market for purified lutein. Marigold is the crop used to produce 95% of global pure lutein and we will significantly increase lutein content of this crop through manipulation of gene expression, based on an existing proof of concept. The technical feasibility of modulating gene expression in marigold (stable lines that can be regenerated) has been demonstrated. In this phase 1 project, HRB will further research the feasibility of this business case, with a focus on complying with relevant international regulatory aspects. In addition, we have a collaboration with Wageningen University (WUR), among the world’s foremost agricultural research institutes, to work towards a major technical milestone: proof of concept that manipulating gene expression in marigold results in significantly increased lutein yields. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The promised technical tasks have been successfully completed at WUR as described in our proposal; one task is still ongoing as of this writing and will continue beyond the end of the project, as was anticipated in the proposal.From the start of the project, a major global player in the lutein and marigold markets was involved in an advisory role and as a potential customer of HRB. They shared valuable insider knowledge of the lutein and marigold markets and, importantly, indicated a strong interest in HRB’s high-lutein marigold. For the latter, the prestige associated with an EU grant was a critical factor. HRB and WUR have access to this company's top lutein-producing plant, to directly test the proof-of-concept in this agriculturally relevant cultivar. A positive result would help ensure a fast route to market (and profit) for HRB.With the help of our advisory board and external consultants, through this Phase 1 project we have created an R&D strategy for the next few years, including additional developments with regard to high-lutein marigold (which can be complementary or serve as a “plan B” to the current R&D efforts), as well as other lines of research that involve “plants as factories”. We identified two important challenges for HRB in our proposal, and found solutions for both during our feasibility study. First, the political sensitivity and legal issues surrounding GMO crops may no longer be an issue in the EU in the nearby future, as countries are starting to allow the use of the CRISPR-Cas9 technology as a non-GMO approach to modify crops (e.g. Sweden). In other major markets of interest to HRB (including the USA), GMO aspects form no barrier to our business case. Second, we identified a viable strategy to ensure sufficient protection of our IP.In all, through this EU-funded project, we confirmed that our high-lutein marigold business case is highly viable, and worth to develop further from a technical as well as a business perspective. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Progress beyond state of the art consists of providing novel insights into the biochemical pathways involved in formation of lutein in Marigold, and on differences in carotenoid contents of different Marigold cultivars. WUR and HRB plan to publish these results in peer-reviewed scientific journals.Our project is expected to yield impacts at several levels:(1) substantial growth for HRB, in profits and FTEs;(2) bring growth to companies with whom HRB enters into licensing agreements;(3) further expand the public-private partnership established during this project, which will bring funds, employment and scientific opportunities to our academic partners;(4) help maintain a global competitive position for Europe in plant biotechnology;(5) contribute to the political discussions on ethical and regulatory aspects of GMOs, which is especially relevant with current events regarding the CRISPR-Cas9 technology;(6) further into the future, indirectly create jobs by helping bring markets that are currently mainly located elsewhere, such as the lutein market, to Europe. HRB company logo Marigold from the project in the WUR greenhouse A typical marigold field
