Results and potential impact
Securing Orphan Drug Designation (ODD) from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) represents a major breakthrough for the i-Thymus project. The early recognition by two regulatory authorities not only highlights the therapeutic promise and unique impact of our innovation but also facilitates a streamlined path to market. With ODD status, i-Thymus will benefit from regulatory support, financial incentives, and market exclusivity once approved, all of which accelerate our timeline and enhance the project’s impact. This ODD underscores our commitment to addressing an urgent unmet medical need for patients born without a thymus and strengthens our position as a leader in pioneering therapies for rare immune disorders.
To protect the intellectual property underpinning this innovation, we have filed a patent application and registered trademarks that secure both our proprietary technology and brand identity. This IP strategy is vital as it ensures long-term competitive advantage, supports future licensing opportunities, and enables us to attract and retain investment to further develop and expand our platform.
Another pivotal result has been the optimisation of our gene therapy vector. Our vector is also suitable for Good Manufacturing Practice (GMP) production, a critical step for ensuring consistent quality and safety at clinical scale.
Key needs to ensure further uptake and success
A key need is now the establishment of a GMP network for transitioning from pre-clinical to clinical stage upon the finalisation of GMP processes; discussions with suitable partners are currently ongoing.
Another key need is the ongoing Series A financing, for which we have commitments and several planned follow-on discussions with potential investors. In the light of outreach, we have elevated our company’s online presence with a professionalised brand and website that now includes expanded technology content, the entire team, and a dedicated news section, providing a more informative and engaging experience for our audiences (www.genewity.tech).
With our recent additions of an experienced COO and a CFO with background and network in venture capital, our team is further strengthened in operations and finance. For this, they are supported by our advisors as seasoned experts from science, clinic and industry. This, alongside our active capital-raising efforts, underscores our growth trajectory and commitment to our mission. In total, the team has grown as a direct result of the project in the past year with the additional hiring of a third senior researcher, an experienced research technician, and a dedicated project manager.
