#Sweden #gene therapy #Lund #Hansa Biopharma #imlifidase

Hansa Biopharma to Attend the 2025 J.P. Morgan Healthcare Conference

Hansa Biopharma AB, a pioneering biopharmaceutical company based in Lund, Sweden, announced today that its management team will participate in the upcoming 43rd Annual J.P. Morgan Healthcare Conference in 2025. This prestigious event provides an excellent opportunity for the company to highlight its innovative advancements in the treatment of autoimmune diseases, gene therapy, and transplantation.

In the past year, Hansa Biopharma has marked considerable progress in its three main therapeutic domains: autoimmune diseases, gene therapy, and transplantation. The company recently reported promising findings from its Phase 2 trial (15-HMedIdeS-09) focused on Guillain-Barré Syndrome (GBS), presenting data that emphasizes the potential of imlifidase, its first-generation IgG-cleaving molecule, to address significant unmet needs in GBS treatment. This was complemented by the completion of enrollment in the GOOD-IDES-02 Phase 3 trial that studies anti-glomerular basement membrane (anti-GBM) disease and the ongoing success of the NICE-01 Phase 1 trial, which demonstrated rapid IgG reduction and admirable potential for re-dosing with HNSA-5487, a second-generation product under development.

Among its gene therapy initiatives, Hansa Biopharma has kicked off two pivotal trials. The SRP-9001-104 Phase 1b trial in collaboration with Sarepta Therapeutics, Inc. evaluates the use of imlifidase as a pre-treatment for patients suffering from Duchenne Muscular Dystrophy (DMD). Concurrently, the GNT-018-IDES Phase 2 trial aims to assess the compound in patients affected by Crigler-Najjar Syndrome in partnership with Genethon. Both studies highlight the role of imlifidase in mitigating the pre-existing antibodies that often thwart effective gene therapy applications.

In the transplantation space, the crucial ConfIdeS pivotal US Phase 3 study has concluded its randomization process. Notably, IDEFIRIX—commercially available as imlifidase—witnessed a record-breaking sales performance in Q3 2024, achieving a remarkable 69.5 MSEK ($6.4M), underscoring its growing importance in kidney transplants, particularly for desensitizing highly sensitized patients.

Looking ahead, Hansa Biopharma aims to hit multiple strategic milestones in 2025:

• - The pivotal US Phase 3 ConfIdeS trial results and planned submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) planned for the latter half of 2025.
• - Anticipated data readouts from Sarepta Therapeutics' Phase 1b trial in DMD and the GOOD-IDES-02 Phase 3 trial in anti-GBM during the same period.
• - Initial alignment discussions regarding the development path for HNSA-5487 in treating neuro-autoimmune diseases, specifically focusing on myasthenia gravis (MG) in the first half of 2025.

Hansa Biopharma is at the forefront of developing novel immunomodulating biologic therapies via its proprietary IgG-cleaving platform. The aim is to treat a variety of IgG-driven immunological conditions, contributing to significant advancement in patient care. With imlifidase’s conditional EU approval for desensitization in kidney transplantation and ongoing late-stage trials in autoimmune diseases, the company's pharmaceutical contributions are surging.

The involvement at the J.P. Morgan Healthcare Conference aims to further showcase Hansa's commitment to innovative therapies and engage with potential partners and stakeholders in the healthcare ecosystem. Interested parties wishing to arrange a meeting with the Hansa team are encouraged to make contact via the company's official communication channels.

For updates on Hansa Biopharma's progress and initiatives, follow them on LinkedIn or visit their website at www.hansabiopharma.com.

About Hansa Biopharma

Founded in 2008, Hansa Biopharma is dedicated to developing transformative therapies for patients with rare immunological conditions. With a robust pipeline stemming from its pioneering IgG-cleaving enzyme technology, the company addresses critical unmet medical needs across its focus areas, contributing to improved healthcare outcomes internationally.

Stay tuned for more updates from Hansa Biopharma as they continue on their journey towards innovation in the healthcare sector.