If you are a cell therapy developer dealing with the high failure rate of IBD drugs in human trials — this project developed a GMP-compliant production method for DP8α Tregs that provides a clinically suitable treatment candidate.
Cell-Based Immunotherapy and Advanced Gut Organoid Models for Inflammatory Bowel Disease Treatment
Imagine your gut has a security team that accidentally attacks your own body, causing chronic inflammation. This project trains a specific group of 'peacekeeper' cells to stop that attack and heal the gut. To test this without using animals, they are growing miniature, lab-made human guts that act like a realistic testing ground.
What needed solving
Current IBD treatments often require lifelong medication or surgery due to a lack of targeted therapies. Animal models are often ineffective for testing human gut immunotherapies due to biological differences.
What was built
A GMP-compliant production process for DP8α Tregs and a bioprinted, vascularized human gut organoid model (PDLM) for preclinical testing.
Who needs this
Who can put this to work
If you are a pharmaceutical R&D firm dealing with the inaccuracy of animal models for human gut diseases — this project developed a vascularized, bioprinted organoid model that mimics human intestinal physiology for better toxicity testing.
If you are a microfluidics manufacturer dealing with a lack of complex biological testing platforms — this project developed a microfluidic device to integrate immune and neural cells into gut organoids.
Quick answers
What is the estimated cost of the therapy?
Based on available project data, the specific cost per treatment is not provided; however, the project is supported by an EU contribution of EUR 6,383,217 for development.
Can this be produced at an industrial scale?
The project is currently setting up conditions to produce DP8α Tregs in a GMP (Good Manufacturing Practice) format, which is the standard required for industrial pharmaceutical scaling.
What is the IP and licensing status?
Based on available project data, specific patent numbers or licensing terms are not listed, but the project aims to deliver a preclinical package ready for Phase 1 clinical trials.
What regulatory hurdles are being addressed?
The project is specifically developing a preclinical package that includes regulatory in vitro and in vivo toxicity data to satisfy clinical trial requirements.
What is the timeline for clinical application?
The project runs from 2023-05-01 to 2027-04-30, with the goal of delivering a product ready for a phase 1 clinical trial by the end of the period.
Who built it
The consortium is highly balanced for commercialization, featuring a 43% industry ratio with 3 industrial partners, including 2 SMEs. This mix of 7 partners across 4 countries (FR, DE, ES, PT) combines academic research from institutes like INSERM with industrial capacity, suggesting a strong pipeline from lab discovery to GMP production.
Contact the Institut National de la Santé et de la Recherche Médicale (INSERM) in France.
Talk to the team behind this work.
Contact SciTransfer to explore licensing opportunities for the DP8α Treg production method.