Entry point and offering
Based on very promising results from the research of the institute, the opportunity arose to bring a drug candidate into clinical trials and, hopefully, longer term to patients in need. The question was, how to make this happen.
RNATICS develops RNA therapeutics directed at disease-causing RNAs in macrophages, immune cells of the body. The proprietary targeting technology allows efficient drug delivery and modulation of their disease-causing activity. This novel delivery pathway enables access to organs previously not accessible to RNA therapeutics offering tremendous therapeutic opportunities.
The first challenge was to find the right people to set up and start the company outside of the lab. In the lab, we had all the necessary know-how about the science, but not what it takes to bring it into clinical application.
Furthermore, we didn’t have sufficient regulatory expertise to know what is expected from the regulatory authorities to develop a drug candidate. For an initial Scientific Advice Meeting, it is crucial to receive feedback about the path to go.
Then, funding was important to support the cost-intensive activities of drug development. In order to fulfill the requirements of a very competitive public funding scheme, all aspects of drug development (production, regulatory, pre-clinical safety & toxicology) needed to be addressed.
Also, IP was fundamental from the start and negotiating a license agreement for the technology from TUM was important.
How VL helped us
The Venture Lab Healthcare provided crucial connections to field experts that could advise us on the overall activities required to start the drug development process. They helped us to apply for an initial Scientific Advice Meeting with the authorities and to successfully conduct the meeting.
Furthermore, they supported us in acquiring an exclusive license for the underlying technology from TUM by explaining potential options, connecting us with the relevant people involved, and ensuring a continuous process.
In addition, the VL Healthcare was a valuable sounding board and partner for addressing questions and issues throughout the company setup process.
The assistance from the VL Healthcare ultimately contributed to the successful application for public funding from BMBF as seed financing for RNATICS (~7M€).
Advice for founders
To successfully bring a drug candidate into clinical practice, an interdisciplinary team of experts is crucial. Try and include the key expertise (clinical patient insight, production, vendor management) in the team from the beginning.