Roadmap
Phase Ⅰ（0-6M） Antigen & Epitope Validation
•AI-driven design and construct finalization.
•Public release of immunogenicity datasets.
•DAO governance vote to advance.
Phase Ⅱ（6-12M） In Vitro Validation
•mRNA synthesis and LNP formulation.
•Expression and immunogenicity assays.
•Open data dashboards and replication bounties.
Phase Ⅲ（12-30M） Preclinical Studies
- AD transgenic mouse testing, behavioral assays, and pathology.
- Open publication and DAO-reviewed reports.
Phase Ⅳ（18-24M） Advanced Preclinical Validation
•Dose optimization, aged-mouse studies, biodistribution, and autoimmunity screens.
•Multi-lab replication consortia and GLP-ready datasets.
Phase Ⅴ（24-36M） Translational Readiness
•GMP scale-up, regulatory consultation, and Phase I trial design.
•DAO and patient advocate governance on trial design.
Regulation and Compliance
•Early engagement with FDA, EMA, and TGA to align preclinical and CMC requirements.
•GLP toxicology in two species, with datasets openly published for community review.
•IND dossier assembled via modular, transparent documentation.
•Ethical oversight built on ARRIVE/IACUC standards, patient-advocate DAOs, and dynamic e-consent.
Budget Framework
•Tier A ($823k): Discovery and exploratory preclinical work.
•Tier B ($3.35M): IND-enabling studies and GMP manufacturing.
•Tier C ($4.9–6.7M): IND submission and Phase I clinical trial.