Mabion Enters Rare Disease Collaboration with Oddifact

Editor’s Take: The collaboration will combine Mabion’s biologics development and manufacturing expertise with Oddifact’s AI-enabled orphan drug identification platform to explore new indications for CD20, which has already secured two FDA Orphan Drug Designations.

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 program through a new strategic development approach.

The collaboration builds on Mabion’s 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 a new 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 program successfully completed Phase III 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 program generated significant development and process knowledge that now supports its repositioning in orphan disease indications. 

MabionCD20 has secured two FDA Orphan Drug Designations for membranous nephropathy and autoimmune hemolytic anemia.

Oddifact is a TechDev platform that transforms off-label uses of existing drugs into authorized treatments for rare disease patients. Its AI platform, S.A.V.E., is designed to identify promising off-label opportunities emerging from real-world medical practice and convert them into complete ‘Orphan Programs’, which are then licensed to pharmaceutical companies for regulatory approval and commercialization. These programs include orphan drug designations, clinical evidence, CMC, supply agreements, regulatory strategy, and go-to-market roadmaps.