If you are a cell therapy developer dealing with low efficacy in autoimmune treatments — this project developed a second generation of tolerogenic DC products that use AI and gene transfer to improve potency. This allows for a more durable treatment for MS patients.
Next-Generation Cell Therapy to Treat Multiple Sclerosis and Autoimmune Diseases
Imagine your immune system is like a security team that has started attacking your own body by mistake. This project trains a special group of 'peacekeeper' cells to tell the rest of the immune system to stop the attack. By using genetic tweaks and AI, they make these peacekeepers stronger and more precise. The goal is to stop the disease at its root rather than just masking the symptoms with lifelong medication.
What needed solving
Current MS treatments require lifelong administration and cause adverse side effects because they only dampen inflammation. There is an unmet need for a one-time or long-term therapy that targets the cause of the disease to restore immune tolerance.
What was built
A second-generation ATMP based on VitD3-modified tolerogenic dendritic cells, supported by an AI prediction tool for quality and an optimized manufacturing protocol.
Who needs this
Who can put this to work
If you are a diagnostics firm dealing with unpredictable patient responses to immunotherapy — this project developed an AI-based prediction system to optimize product quality. This ensures the manufactured cells are effective before they reach the patient.
If you are an ATMP manufacturer dealing with complex production protocols for immune cells — this project developed an optimized manufacturing protocol and regulatory roadmap. This reduces the risk of failure during the transition to first-in-man clinical applications.
Quick answers
What is the estimated cost of development?
The project is supported by an EU contribution of EUR 5,999,340. Based on available project data, specific per-unit production costs are not provided.
Can this be produced at an industrial scale?
The project specifically aims to optimize the protocol for the manufacturing of the product to guarantee commercial application. It involves 4 industrial partners to help bridge the gap to scale.
How is the intellectual property or licensing handled?
Based on available project data, specific licensing terms are not listed, but the project includes a business plan to guarantee commercial application of the advanced product.
What regulatory hurdles are being addressed?
The project follows a regulatory roadmap continuously assessed by regulatory bodies to design a clinical protocol for first-in-man application of engineered cells.
What is the timeline for clinical application?
The project period runs from 2023-05-01 to 2027-04-30, aiming to move from optimization to a clinical protocol for human application.
Who built it
The consortium is well-balanced for commercialization, featuring 11 partners across 5 countries. With an industry ratio of 36% (including 4 industrial partners and 3 SMEs), there is a strong bridge between the 3 universities and 3 research institutes and the actual market. This structure suggests a high priority on translating lab results into a viable business plan.
Contact Fondazione Telethon ETS in Italy
Talk to the team behind this work.
Contact us to explore licensing opportunities for the AI-optimized DC manufacturing protocol.