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.
Oddifact is a TechDev platform that transforms off-label uses of existing drugs into authorized treatments for rare disease patients. Its proprietary 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.
This collaboration reflects Mabion’s broader strategy to unlock additional value from existing scientific assets and expand beyond traditional CDMO activities through selected high-value co-development opportunities.
“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.
“Alongside our CDMO operations, we want to focus on projects with high added value that allow us to utilise the scientific expertise developed over many years at Mabion. The reactivation of the MabionCD20 project in orphan diseases is not only an opportunity to unlock the commercial potential of this asset, but also an important step toward building a portfolio of innovative products developed in a co-development model, where both risks and future benefits are shared with our partners.”
In line with its mission to unlock untapped medical research and accelerate patient access to treatment, Oddifact has secured 15 FDA Orphan Drug Designations across US & EU, becoming one of the world’s most prolific orphan drug designation generators and delivering a faster, cheaper and de-risked alternative to traditional drug development.
“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.”
Under the terms of the LoI, the companies will initially focus on developing a regulatory strategy and preparing materials for potential investors and regulatory authorities, including the U.S. Food and Drug Administration (FDA). The parties then intend to enter into a binding Cooperation Agreement by the end of 2026 covering future development and commercialization activities for MabionCD20 in orphan disease indications.
