drugset / Press release

Mabion is back – reactivation of the MabionCD20 project opens the way to commercializing the drug in the orphan diseases area

2026-05-08 · Mabion SA · original mabion.eu ↗

Phone +48 42 207 78 90 Email address: [email protected] www.mabion.eu 1 Poland, Konstantynów Łódzki, 8th May, 2026 Press release Mabion is back – reactivation of the MabionCD20 project opens the way to commercializing the drug in the orphan diseases area Mabion S.A., Polish biotechnology company, has signed a letter of intent (LoI) with the French company Oddifact SAS to jointly develop the drug MabionCD20, paving the way for the use of the Company's advanced scientific knowledge in the new area of orphan diseases The cooperation with the French TechDev partner is the result of the consistent implementation of Mabion's new strategy, which assumes, among other things, the extension of the CDMO model to the implementation of selected projects with high added value and the construction of a product portfoli o based on its own IP The letter of intent stipulates that in the first stage, lasting until September 30 this year, the parties will jointly develop materials for the purpose of obtaining financing, as well as participate in meetings with regulatory authorities regarding key decisions regarding the drug MabionCD20 In the second stage, after determining the possibilities and conditions of use of the MabionCD20 drug, the parties will determine further steps, including their material and financial contribution, which will be specified in the Cooperation Agreement and the relevant Statement of Work Oddifact SAS's use of artificial intelligence (AI) to identify new clinical indications, combined with Mabion's expertise, aims to accelerate regulatory processes before the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) The collaboration between Mabion S .A. and Oddifact SAS involves researching and evaluating the potential use of MabionCD20 in new clinical indications in the area of orphan diseases. 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 developed by the Company as a biosimilar candidate to MabThera and Rituxan (used in the treatment of lymphoma and rheumatoid arthritis, among other indications). Although this project was crucial for Mabion in its earlier years, it never reached the registration stage in its original form. This collaboration with Oddifa ct SAS represents a breakthrough opportunity to revive this project and fully commercialize it in a new form. By leveraging the scientific knowledge accumu lated over the years and advanced process data, Mabion intends to introduce 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 the 2025-2030 Strategy, which we presented to investors at the end of last year. In addition to implementing CDMO contracts for our clients, we want to focus on projects with high added value, which allow us to utilize the scientific knowledge developed over the years at Mabion. The reactivation of the MabionCD20 project in the area of orphan diseases is not only an opportunity for its rapid commercialization, but also an element of building a portfolio of innovative products that will generate revenues in a co - development model, where we share the risks and costs with the partner, as well as future profits" – said Gregor Kawaletz, Chief Executive Officer of Mabion S.A. ODDIFACT is a TechDev platform that transforms off -label uses of existing drugs into authorized treatments for rare disease patients. Its proprietary AI backbone, S.A.V.E., identifies promising off -label opportunities emerging from real - world medical practice and converts them into complete “Orphan Programs,” which are then licensed to pharmaceutical Phone +48 42 207 78 90 Email address: [email protected] www.mabion.eu 2 companies for regulatory approval and commercialization. These programs include orphan drug designations, clinical evidence, CMC, supply agreements, regulatory strategy, and go-to-market roadmaps. In line with its mission to unlock untapped medical research and accelerate patient access to treatment, ODDIFACT has secured 13 FDA Orphan Drug Designations in under 24 months, 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 - proven safety profile, existing clinical data, and unexplored rare disease indications. Entering discussions with Mabion, a reference CD20 manufacturer, is a decisive milestone as we accelerate the licensing of our orphan programs to pharmaceutical partners " – comments Pierre-Alexandre Teulié, President of ODDIFACT. The letter of intent between Mabion SA and Oddifact SAS envisages a two-stage collaboration process. In the first phase, which the parties intend to complete by September 30, 2026, the Mabion and Oddifact teams will jointly prepare a regulatory strategy an d materials for potential investors and regulatory authorities, including the U.S. Food and Drug Administration (FDA). The second phase involves the execution of a binding Cooperation Agreement by the end of 2026, which will determine the final material and financial contribution of both parties to the development and commercialization of the drug. Contact for media and individual investors Michał Wierzchowski +48 531 613 067 +48 22 440 14 40 [email protected] Mardoniusz Maćkowiak +48 605 959 539 +48 22 440 14 40 [email protected] Contact for institutional investors and analysts Piotr Owdziej +48 697 612 913 +48 22 440 14 40 [email protected] Information about Mabion Mabion S.A. (WSE:MAB) is a publicly traded Polish biopharmaceutical company, founded in 2007, which underwent a transformatio n in 2023–2024 into a biologics -focused CDMO (Contract Development and Manufacturing Organization) offering an integrated service portfolio. Mabion specializes in small to mid -sized projects at various stages of development – from early-stage development of stable cell lines to commercial manufacturing. Mabion’s core competencies include monoclonal antibody development technologies, recombinant protein production (using mammalian and insect cell expression systems), advanced analytics, and manufacturing of Drug Substance. The company operates in compliance with globally recognized quality standards, including GMP, GCP, and ISO. Mabion employs over 200 highly qualified professionals, including scientists, engineers and experts in quality, manufacturing and analytical development for biologics. Headquartered in the center of Europe, Mabion operates in Poland – an EU member state – providing access to highly regulated markets. The company's mission is to be a trusted global partner for the development and manufacturing of biologic medicines. Mabion is a public company listed on the Warsaw Stock Exchange. More information: www.mabion.eu

The release as fetched from its publisher. mabion.eu ↗