#NewAseBioMember | "AseBio has established a unique platform for the exchange of knowledge and collaboration, with a clear focus on promoting innovation"

AseBio. What does your company's work bring to the table and what is its strength?

Rafael Correa-Rocha. Established in the year 2022, THYTECH emerges as a dynamic company derived from the Gregorio Marañón University General Hospital in Madrid.

THYTECH stands out as a pioneer in the development of regulatory T cells, leveraging an innovative cellular source: the thymus. This primary lymphoid organ becomes an abundant source of high-quality Tregs, known as thyTreg cells, exhibiting optimal characteristics for their implementation in cellular therapies for diseases associated with hyperstimulation of the immune system.

Currently, ThyTreg cells are in the clinical trial phase for autologous application in pediatric patients undergoing heart transplantation. Nevertheless, THYTECH's primary objective is to demonstrate the robustness of their functionality in an allogeneic environment, capitalizing on the minimal immunogenicity of these cells.

Consequently, THYTECH is dedicated to generating cutting-edge technology focused on Treg cell therapies with proprietary protocols, ready for use, targeting individuals facing severe immunological and inflammatory disorders.

AseBio. What is AseBio for you?

Rafael Correa-Rocha. AseBio is a prominent entity known for bringing together and representing the interests of organizations affiliated with the field of biotechnology in Spain. AseBio has established a unique platform for the exchange of knowledge and collaboration, with a clear focus on promoting innovation. Through these connections forged over more than 20 years of commitment to the biotechnological sector, we believe that AseBio is the ideal platform to enable THYTECH, as a small-sized spin-off, to establish links with individuals, companies, and associations within the biotechnology sector who can comprehend, support, or collaborate with it.

AseBio. When did you first hear about AseBio?

Rafael Correa-Rocha. While Asebio is a recognized network in Spain, and we were indirectly aware of its significant work in the field of biotech companies, it wasn't until the Asebio-Merck Award call, to which we submitted our application, and the in-person event that we were able to fully appreciate everything it has to offer and begin interacting with the network's members.

AseBio. What do you expect from being part of an association like AseBio?

Rafael Correa-Rocha. Collaborating with AseBio represents a valuable opportunity for the growth of THYTECH as a company, thanks to the contacts that AseBio may have within its community of affiliated companies. We are confident that, owing to its active participation in national and international networks, AseBio will provide enhanced visibility to THYTECH, creating opportunities for funding and, consequently, for growth. Furthermore, it will enable us to establish connections with potential collaborators who share our concerns regarding the improvement of health and the economic development of small and medium-sized enterprises (PYMES).

AseBio. What is the biggest challenge facing the biotech sector (or your company)?

Rafael Correa-Rocha. From our perspective, the major challenge confronting the Biotech sector in Spain, with a focus on the field of cellular therapies, lies primarily in regulations at both national and European/international levels. In the realm of living medicines, regulations are crucial to ensure not only the safety, efficacy, and quality of these innovative treatments but also play a fundamental role in public trust and acceptance of these groundbreaking therapies. Therefore, the challenge lies in refining the authorization, registration, and, particularly, the dispensation conditions for industrially manufactured human-use medications.

The hurdle faced by biotechnology companies developing cellular therapies stems from the regulations imposed by treatment-funding agencies. These regulations must adapt to the increasing complexity and rising costs of medications, which are becoming more advanced over time.

For our recently established company, the primary challenges we face are as follows:

• Development of allogeneic manufacturing protocols that meet the scaling needs and facility availability, as most current trials rely on autologous procedures.
• Securing funding through public calls or investment funds.
• Adapting the development of the therapeutic product and its indications to the current international regulatory standards (EMA and FDA).