RESTORING IMMUNITY CONTROL OF GI CANCERS

Introduction

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.

Targeted Nano-immune Modulator (TNM) Platform

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.

Complementary Strategies

This approach combines two complementary tumor-killing strategies. Unlike conventional cancer immunotherapies, TNM stimulates both:

1. Cytotoxic T cells
2. Powerful B cells, which differentiate into:
   • Long-lived memory T and B cells
   • Antibody-secreting plasma cells capable of producing high-affinity antibodies

Product Development Stages

TIMNano aims to progress through the five stages of product development, including:

1. Good Manufacturing Practice (GMP) production (with technology transfer and scale-up already accomplished)
2. Non-clinical efficacy studies
3. Safety studies
4. Toxicokinetic studies

The use of industrial-scale products is planned 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

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
• Investment banks

This support is crucial to further complete the clinical development program by ourselves or upon merger and acquisition deal with a larger Pharma company.