We propose the release the rest of the 49.34 ETH (~$117k currently) from the VitaRNA treasury in support of the experimental plan as outlined in the VITARNA Whitepaper and our recent data demonstrating that we are progressing on the plan set forth on the approved VRNAP-2.
As the Whitepaper and VNRAP-2 outlined,$100Kwas authorized to support lead construct development further. Specifically, after establishing the cell-based assay to screen constructs, Artan Bio was to take the lead constructs that showed activity as naked plasmids and produce theAAV9 virus, characterize the virus, and confirm that the AAV9 vector can deliver our construct and demonstrate activity in cells. This was accomplished and shared with the community across multiple channels:
Artan Bio and Dr. Torres will work to validate the lead constructs in animal models that would serve as the preclinical data to support further development and lead candidate selection. It is critical to the development path to getting our drug into humans that we begin working with manufacturers who can make our drug sufficient for IND-enabling studies. This requires what is called cGMP (current Good Manufacturing Practices). Artan Bio believes the manufacturing organization Lonza is the right partner. Per the Lonza proposal:
While it is possible to go to cheaper manufacturers, if we make drug product now with Lonza using their platform, we will be able to quickly scale up the drug product to support IND-enabling studies. Additionally, the high-quality material made for this initial feasibility study will be more than sufficient for further experiments in animal models.
Phase 1: Initial shake flask studies at Lonza (study + materials): $70K
Phase 2: Large-scale bioreactor run: $210K
As noted above, the total amount exceeds the request. We will work with Lonza to reduce the cost as much as possible. Additionally, we will add a stage gate between Phase 1 and Phase 2, and fundraise for the remaining amount via to-be-determined methods.
##Expected Outcome(s)
AAV drug candidate(s) for testing in mice made with a platform that supports GMP manufacturing
This proposal ensures that allocated funds are used efficiently and effectively, driving forward our scientific goals while maintaining transparency and accountability to the community.
To date, Artan Bio has been active in sharing results through various channels.
VitaRNA token holders will have exclusive access to the final report and any detailed findings, ensuring that community members are directly informed and involved.