The Polish biotech company Mabion has signed a letter of intent (LoI) with French rare disease specialist Oddifact SAS to evaluate the potential of MabionCD20 in orphan disease indications.
The announcement marks the revival of the company's CD20 development programme.
Oddifact specialises in transforming off-label uses of existing medicines into approved orphan therapies.
Its platform combines clinical evidence, regulatory planning, chemistry, manufacturing and controls (CMC) expertise and commercialisation strategies to develop complete orphan drug programmes for licensing to pharmaceutical partners.
The collaboration combines Mabion's experience in monoclonal antibody development and biologics manufacturing with Oddifact's AI-powered orphan drug identification platform, S.A.V.E., which is designed to identify and validate new rare disease applications for existing therapies.
MabionCD20 was originally developed as a biosimilar candidate to rituximab, marketed as MabThera and Rituxan and successfully completed Phase III clinical trials.
While the programme did not ultimately progress to registration, the company says it generated "significant clinical, scientific and manufacturing data" that could support future development in alternative indications.
Under this new agreement, Mabion and Oddifact will assess opportunities to reposition the anti-CD20 monoclonal antibody for rare disease applications.
The asset has already received two FDA Orphan Drug Designations for membranous nephropathy and autoimmune haemolytic anaemia, providing an established regulatory foundation for further development.
According to Mabion, the collaboration aligns with its 2025-2030 corporate strategy, which seeks to expand the company's activities beyond traditional CDMO services through selected co-development opportunities.
Gregor Kawaletz, CEO of Mabion, said the project represents an opportunity to unlock additional value from the company's scientific assets.
"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.
Pierre-Alexandre Teulié, President of Oddifact, added that MabionCD20 combines a well-characterised safety profile with existing clinical data, making it a strong candidate for investigation in rare disease settings.
Entering discussions with Mabion, a reference CD20 manufacturer, is a decisive milestone as we accelerate the licensing of our orphan programmes to pharmaceutical partners.
The companies will initially focus on developing a regulatory strategy and preparing materials for discussions with investors and regulatory authorities, including the FDA.
Subject to the outcome of these activities, Mabion and Oddifact intend to negotiate a binding cooperation agreement by the end of 2026 covering future development and commercialisation of MabionCD20 in orphan disease indications.
