If you are a biotech drug developer dealing with the limitations of lifelong insulin therapy — this project developed DGX-01 that regenerates pancreatic beta-cells. This allows for autonomous insulin production and potentially cures T1D.
Regenerative Therapy to Cure Type 1 Diabetes by Restoring Insulin-Producing Cells
Imagine your body's insulin factory has been shut down, forcing you to manually inject fuel every day just to survive. This project developed a special protein that acts like a 'restart button' for those factories. It tells the pancreas to grow new insulin-producing cells so the body can manage blood sugar on its own again.
What needed solving
Type 1 Diabetes requires lifelong insulin injections and strict diets, yet less than 20% of patients reach target glucose levels. This leads to severe complications and a reduction in life expectancy by 10-15 years.
What was built
A lead drug candidate (DGX-01) and a GMP-compliant manufacturing process, including a stable monoclonal cell line and a purification cascade.
Who needs this
Who can put this to work
If you are a clinic dealing with patients where less than 20% achieve target glucose levels — this project developed a regenerative therapy that restores beta-cell function. This could significantly reduce vascular complications like stroke and renal disease.
If you are an investor dealing with high-demand unmet needs in the 8.75M T1D population — this project developed a lead candidate, DGX-01, with a favorable non-clinical safety profile. It is moving toward clinical proof of principle in 2026.
Quick answers
What is the licensing strategy for this technology?
The company intends to out-license the drug to a pharmaceutical company. Some pharma companies have already invested in the capital of DiogenX.
Can this be produced at an industrial scale?
Yes, the project established a purification cascade achieving >99% purity at a 250 L toxicology-scale and created a GMP Master Cell Bank for manufacturing.
What is the timeline for human testing?
Clinical proof of principle in humans is expected to be reached in 2026.
What is the cost of the treatment?
Based on available project data, the specific price or cost per dose is not disclosed.
How is the safety of the lead candidate verified?
DGX-01 demonstrated a favorable non-clinical safety profile across mice, rats, and cynomolgus monkeys with no adverse findings.
Who built it
The project is led by a single French SME, DIOGENX SAS, representing a 100% industry ratio. This lean structure suggests a highly focused, agile development path aimed at rapid transition to clinical trials and licensing, rather than a broad academic research collaboration.
Contact DIOGENX SAS in France for licensing inquiries regarding DGX-01.
Talk to the team behind this work.
Contact SciTransfer to facilitate a partnership with DiogenX for T1D regenerative medicine.