Regulatory and IP strategy for TrojanDC cancer gene therapy
| Reference number | |
| Coordinator | Asgard Therapeutics AB |
| Funding from Vinnova | SEK 300 000 |
| Project duration | April 2019 - November 2019 |
| Status | Completed |
| Venture | Innovative Startups |
Purpose and goal
The project’s goal was to define the regulatory and intellectual property (IP) strategies for Asgard Therapeutics, in its development of a new cancer immunotherapy. We have met our goal by meeting the 2 subgoals: understand the regulatory landscape and design the non-clinical and clinical development plan for our therapy accordingly; define a strategy to create a patent family protecting our technology and how new data from PoC studies will be used to generate new patent applications.
Expected results and effects
The project resulted in a regulatory report, with detailed plan for the non-clinical and CMC activities for the next 2 years. This plan guarantees regulatory compliance of our therapy and future approval for clinical trial. The project also resulted in a document defining Asgard IP strategy and SOPs for handling technology development and its potential patentability. Both documents are serving as basis to define financing requirements and support ongoing discussions with investors.
Planned approach and implementation
Asgard’s team has selected and worked with a regulatory consultant with expertise in gene therapies. We have reviewed PoC data and designed a future plan for Non-clinic and CMC activities required to submit a Clinical Trial Application. Through dialogue with KOL in immune-oncology, we have also identified top target indications for our cancer gene therapy. We have also defined an IP strategy to secure protection of our technology and future developments, with the help of IP consultant.