RESTORING IMMUNITY CONTROL OF GI CANCERS

ongoing

TIMNano is focused on Computer-Aided Drug Design (CADD) methods and bioinformatics to identify unique molecular fingerprints associated with gastrointestinal (GI) cancers using 3D-bioprinted patient-derived tumors. The project integrates nanotechnology, bioinformatics, immunology, and cancer biology to develop a novel platform utilizing immune cell-targeted biodegradable polymeric nanoparticles (NPs) aimed at enhancing therapeutic efficacy by inducing tumor destruction following optimal T- and B- cell activation. The Targeted Nano-immune Modulator (TNM) platform specifically targets local dendritic cells (DCs) to boost T cell-DC chemotaxis within lymph nodes, thus initiating a robust systemic anti-tumor immune response. This approach combines two complementary tumor-killing strategies. Unlike conventional cancer immunotherapies, TNM stimulates both cytotoxic T cells and powerful B cells, which differentiate into long-lived memory T and B cells, as well as antibody-secreting plasma cells capable of producing high-affinity antibodies. TIMNano aims to progress through the five stages of product development including Good Manufacturing Practice (GMP) production (with technology transfer and scale-up already accomplished), non-clinical efficacy, safety, and toxicokinetic studies, using industrial-scale products within the first 2 years. This will be followed by the subsequent filing of an Investigational Medicinal Product Dossier (IMPD) with the European Medicines Agency (EMA) and then a Phase 1/2 clinical trial will be initiated in the third year of the project. Funding and support from the European Innovation Council (EIC) will be critical in founding a spin-off company and securing additional investments from private investors, venture capital and investment banks, crucial to further complete the clinical development program by ourselves or upon merger and acquisition deal with a larger Pharma company.