- Mabion S.A. has signed a letter of intent with Oddifact SAS to evaluate and advance MabionCD20 for potential use in rare diseases, reactivating its CD20 development program.
- The companies plan to develop a regulatory strategy and aim to enter a binding cooperation agreement by the end of 2026, covering future development and commercialization activities.
Mabion S.A. has signed a letter of intent (LoI) with Oddifact SAS, a French TechDev company, to evaluate and advance MabionCD20 for potential use in rare diseases. The agreement marks the reactivation of Mabion’s CD20 program through a development strategy focused on orphan disease indications. The companies said they intend to combine Mabion’s expertise in monoclonal antibody development, clinical advancement and biologics manufacturing with Oddifact’s AI-enabled orphan drug identification platform.
MabionCD20 is a monoclonal antibody originally developed as a biosimilar candidate to MabThera® and Rituxan®. According to the company, the program completed Phase III clinical trials but did not progress to registration in its original form. Mabion said the program generated scientific, clinical and manufacturing knowledge that now supports efforts to reposition the asset for orphan disease applications.
The company noted that MabionCD20 has received two FDA Orphan Drug Designations for membranous nephropathy and autoimmune hemolytic anemia. Under the collaboration, Oddifact’s S.A.V.E. platform will be used to explore additional rare disease indications and support the development of orphan drug programs for potential regulatory approval and commercialization.
The initiative also aligns with Mabion’s strategy to expand beyond its CDMO and contract manufacturing activities through selected co-development opportunities.
“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.”
Gregor Kawaletz, Chief Executive Officer of Mabion S.A.
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. The parties said they 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.
