The TIMNano project aims to develop and validate an innovative Targeted Nano-immune Modulator (TNM) platform to restore immune control over gastrointestinal (GI) cancers particularly those expressing the CEACAM5 antigen. The core objectives include:
Technology Development
Scale up and produce Good Manufacturing Practice (GMP)- compliant TNM-101 nanoparticles and complete Chemistry Manufacturing and Controls (CMC) documentation necessary for clinical trials.
Conduct safety, immunogenicity, biodistribution, and toxicology studies in relevant models.
Prepare for and initiate a Phase 1/2a First-in-Human (FIH) clinical trial.
Validate immunological biomarkers for patient stratification
Develop a business model, IP strategy, and market exploitation plan including potential spin-off creation
