Mabion and Oddifact Partner to Repurpose MabionCD20 for Rare Diseases

Problem Mabion, a Polish biotech company, faced the challenge of reviving its stalled CD20 development program. Despite MabionCD20's successful Phase III clinical trials as a biosimilar candidate to rituximab (MabThera/Rituxan), the program did not progress to registration. However, the company recognized the potential of the asset's existing clinical, scientific, and manufacturing data for alternative applications.

Solution Mabion has signed a letter of intent (LoI) with French rare disease specialist Oddifact SAS to explore the repositioning of MabionCD20 for orphan disease indications. This collaboration leverages Oddifact's AI-powered orphan drug identification platform, S.A.V.E., which identifies and validates new rare disease applications for existing therapies.

Oddifact's expertise in transforming off-label uses of existing medicines into approved orphan therapies complements Mabion's experience in monoclonal antibody development and biologics manufacturing. The partnership aims to develop a comprehensive orphan drug program for MabionCD20, with the goal of licensing it to pharmaceutical partners.

Key elements of the collaboration include: - **Regulatory Strategy**: The companies will develop a regulatory strategy and prepare materials for discussions with the FDA and other regulatory authorities. - **Clinical Data Utilization**: MabionCD20's existing clinical data, along with its well-characterized safety profile, will be used to support the development of the orphan drug program. - **Orphan Drug Designations**: The asset has already received two FDA Orphan Drug Designations for membranous nephropathy and autoimmune haemolytic anaemia, providing a regulatory foundation for further development.

"This collaboration aligns with our 2025-2030 corporate strategy, which seeks to expand beyond traditional CDMO services through selected co-development opportunities," said Gregor Kawaletz, CEO of Mabion.

Results The partnership represents a significant opportunity for Mabion to unlock additional value from its scientific assets. By focusing on high-added-value projects, the company aims to utilize its long-developed scientific expertise. The reactivation of the MabionCD20 project in orphan diseases is not only a commercial opportunity but also a strategic step toward building a portfolio of innovative products developed in a co-development model.

"MabionCD20 combines a well-characterized safety profile with existing clinical data, making it a strong candidate for investigation in rare disease settings," said Pierre-Alexandre Teulié, President of Oddifact.

The companies will initially focus on developing a regulatory strategy and preparing materials for discussions with investors and regulatory authorities. Subject to the outcome of these activities, Mabion and Oddifact intend to negotiate a binding cooperation agreement by the end of 2026, covering the future development and commercialization of MabionCD20 in orphan disease indications.

### Key Facts and Implications for Engineers and Manufacturing Professionals - **Regulatory Progress**: MabionCD20 has already secured two FDA Orphan Drug Designations, providing a head start in the regulatory process. - **AI Integration**: The use of Oddifact's AI platform, S.A.V.E., demonstrates the growing role of artificial intelligence in drug repurposing and development. - **Strategic Shift**: This collaboration is part of Mabion's strategic shift to expand beyond traditional CDMO services, highlighting a trend in the biotech industry toward co-development models. - **Timeline**: The companies aim to finalize a binding cooperation agreement by the end of 2026, indicating a medium-term timeline for development and commercialization.