Mabion S.A., a Polish biotechnology company, has signed a letter of intent with French firm Oddifact SAS for the joint development of MabionCD20. The agreement opens the way for the company to use its advanced scientific expertise in a new area: orphan diseases.
The cooperation with the French TechDev partner is the result of Mabion’s consistent implementation of its new strategy. The strategy assumes, among other things, the expansion of the CDMO model to include selected high value-added projects and the development of a product portfolio based on the company’s own intellectual property.
Under the letter of intent, in the first stage, lasting until 30 September 2026, the parties will jointly prepare materials needed to obtain financing. They will also take part in meetings with regulatory authorities concerning key decisions related to MabionCD20.
In the second stage, after the possibilities and conditions for the use of MabionCD20 have been determined, the parties will agree on further steps, including their material and financial contributions. These will be defined in a cooperation agreement and relevant statements of work.
The use of artificial intelligence by Oddifact SAS to identify new clinical indications, combined with Mabion’s experience, is intended to accelerate regulatory processes before the U.S. Food and Drug Administration and the European Medicines Agency.
MabionCD20 may gain a new path to commercialisation
The cooperation between Mabion S.A. and Oddifact SAS concerns the examination and assessment of the potential use of MabionCD20 in new clinical indications in the area of orphan diseases. Ultimately, the cooperation is intended to lead to a partnership and the registration of MabionCD20 as an innovative treatment for rare diseases.
MabionCD20 is a monoclonal antibody developed by the company as a biosimilar candidate to MabThera and Rituxan, products used, among others, in the treatment of lymphoma and rheumatoid arthritis. Although the project was of key importance to Mabion in previous years, it never reached the registration stage in its original form.
The cooperation with Oddifact SAS represents a significant opportunity to restart the project and fully commercialise it under a new formula. By using the scientific knowledge accumulated over the years and advanced process data, Mabion intends to bring CD20 to the market in a new model — as an innovative therapy addressing unmet medical needs in niche areas of rare diseases.
“The signing of the letter of intent with Oddifact is a consequence of the effective implementation of our 2025–2030 strategy, which we presented to investors at the end of last year. In addition to executing CDMO contracts for our clients, we want to focus on high value-added projects that allow us to utilise the scientific expertise developed at Mabion over many years. Reactivating the MabionCD20 project in the area of orphan diseases is not only an opportunity for its rapid commercialisation, but also part of building a portfolio of innovative products that will generate revenue in a co-development model, where we share the risk and costs with a partner, as well as future profits,” said Gregor Kawaletz, CEO of Mabion S.A.
Oddifact uses AI to identify new uses for existing drugs
Oddifact is a TechDev platform that transforms off-label uses of existing medicines into authorised therapies for patients suffering from rare diseases. Its proprietary AI-based foundation, S.A.V.E., identifies promising off-label opportunities emerging from real-world medical practice and turns them into complete “Orphan Programs”. These are then licensed to pharmaceutical companies for regulatory approval and commercialisation.
The programmes include orphan drug designations, clinical evidence, CMC issues, supply agreements, regulatory strategy and market entry plans.
In line with its mission to unlock the unused potential of medical research and accelerate patient access to treatment, Oddifact obtained 13 orphan drug designations from the FDA in less than 24 months. This has made it one of the world’s most active generators of orphan drug designations and offers a faster, cheaper and lower-risk alternative to traditional drug development.
“CD20 is exactly the type of molecule our platform was built for. It has a documented safety profile, existing clinical data and unexplored indications in rare diseases. Starting discussions with Mabion, a reference CD20 manufacturer, marks a decisive milestone in accelerating the licensing of our orphan programmes to pharmaceutical partners,” said Pierre-Alexandre Teulié, CEO of Oddifact.
Two-stage cooperation process
The letter of intent signed between Mabion S.A. and Oddifact SAS provides for a two-stage cooperation process.
In the first phase, which the parties intend to complete by 30 September 2026, the Mabion and Oddifact teams will jointly prepare a regulatory strategy and materials for potential investors and supervisory authorities, including the U.S. Food and Drug Administration.
The second stage assumes the signing of a binding cooperation agreement by the end of 2026. This agreement will determine the final material and financial contribution of both parties to the development and commercialisation of the drug.
