Mabion S.A., a Polish biotechnology company, has signed a letter of intent (LoI) with French TechDev company Oddifact SAS to evaluate and advance MabionCD20 for potential use in rare diseases, marking the reactivation of the Company’s CD20 programme through a new strategic development approach.

The collaboration builds on Mabion’s extensive expertise in monoclonal antibody development, late-stage clinical advancement and biologics manufacturing alongside Oddifact’s AI-enabled orphan drug identification platform to explore new clinical indications for Mabion CD20. 

Ultimately, this collaboration aims to lead to the partnership and registration of MabionCD20 as an innovative drug for orphan diseases.

MabionCD20 is a monoclonal antibody originally developed by Mabion as a biosimilar candidate to MabThera and Rituxan therapies widely used in the treatment of lymphoma, rheumatoid arthritis and other indications. 

The programme successfully completed Phase III clinical trials, demonstrating the maturity of the asset and providing Mabion with extensive scientific, clinical and manufacturing expertise related to the molecule. 

Although MabionCD20 did not progress to registration in its original form, the programme generated significant development and process knowledge that now supports its repositioning in orphan disease indications. 

Through the collaboration with Oddifact SAS, Mabion intends to reposition the asset for orphan disease applications by leveraging the extensive scientific knowledge, manufacturing expertise and process data accumulated over the course of the programme.

 MabionCD20 has already secured two FDA Orphan Drug Designations (ODDs) for membranous nephropathy and autoimmune hemolytic anemia, further supporting its potential in rare disease applications and reinforcing the rationale for continued development in orphan indications. 

“The signing of the letter of intent with Oddifact is a consequence of the effective implementation of the 2025–2030 Strategy which we presented to investors at the end of last year,” said Gregor Kawaletz, Chief Executive Officer of Mabion S.A. 

“CD20 is exactly the type of molecule our platform was built for one with a proven safety profile, existing clinical data and unexplored rare disease indications,” said Pierre-Alexandre Teulié, President of ODDIFACT. 

“Entering discussions with Mabion, a reference CD20 manufacturer, is a decisive milestone as we accelerate the licensing of our orphan programmes to pharmaceutical partners,” added Teulié.