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About Hansa Biopharma
Hansa Biopharma AB (NASDAQ Stockholm: HNSA) is a pioneering commercial-stage biopharmaceutical company headquartered in Lund, Sweden. The company is dedicated to developing and commercializing innovative, lifesaving, and life-altering treatments for patients with rare immunological conditions. Leveraging its proprietary immunoglobulin G (IgG)-cleaving enzyme technology platform, Hansa addresses significant unmet medical needs in transplantation, autoimmune diseases, and gene therapy. The company operates in Europe and the United States, with its flagship product, IDEFIRIX®, conditionally approved in Europe for desensitization treatment in highly sensitized adult kidney transplant patients.
Proprietary IgG-Cleaving Enzyme Technology
At the heart of Hansa Biopharma’s innovation lies its proprietary IgG-cleaving enzyme technology. This platform enables the rapid and specific targeting of IgG antibodies, which play a critical role in many immunological conditions. By cleaving these antibodies, Hansa’s therapies disrupt IgG-mediated immune responses, creating a therapeutic window for interventions such as organ transplantation and gene therapy. This groundbreaking approach has positioned Hansa as a leader in addressing the challenges faced by highly sensitized patients and those with IgG-driven autoimmune diseases.
Flagship Product: IDEFIRIX®
IDEFIRIX® (imlifidase) is Hansa Biopharma’s first-in-class IgG antibody-cleaving enzyme therapy. It has been conditionally approved in Europe for the desensitization of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. By inactivating donor-specific antibodies, IDEFIRIX® enables successful kidney transplantation in patients who would otherwise face significant barriers due to their immunological profiles. The therapy’s rapid onset of action and efficacy in reducing IgG antibodies have made it a transformative option in the field of transplantation.
Expanding Research and Development Pipeline
Hansa Biopharma is advancing a robust and expanding pipeline based on its IgG-cleaving enzyme technology. Key programs include:
- Autoimmune Diseases: The company is investigating imlifidase and its next-generation molecule, HNSA-5487, for the treatment of severe autoimmune conditions such as anti-glomerular basement membrane (anti-GBM) disease, Guillain-Barré Syndrome (GBS), and myasthenia gravis (MG).
- Gene Therapy: Hansa collaborates with leading gene therapy companies to enable treatments for patients with pre-existing antibodies against adeno-associated virus (AAV) vectors, which often exclude them from accessing potentially curative therapies.
- Transplantation: In addition to kidney transplantation, Hansa is exploring the broader application of its enzyme technology in other organ transplants and related conditions.
Notably, HNSA-5487, the company’s next-generation IgG-cleaving molecule, has demonstrated favorable immunogenicity and redosing potential, underscoring its potential to address chronic and relapsing conditions.
Market Position and Competitive Landscape
Hansa Biopharma operates in the highly specialized biopharmaceutical sector, focusing on rare diseases with limited treatment options. The company’s competitive advantage lies in its proprietary enzyme technology, which offers a unique mechanism of action compared to traditional immunosuppressive therapies. By targeting IgG-mediated immune responses, Hansa addresses critical gaps in transplantation, autoimmune diseases, and gene therapy. Its strategic collaborations with gene therapy leaders further enhance its market positioning and potential for long-term growth.
Commitment to Patients and Innovation
Hansa Biopharma’s mission is to develop transformative therapies that improve patient outcomes and quality of life. Through its innovative technology platform, the company aims to address the root causes of complex immunological conditions, offering hope to patients who previously had limited or no treatment options. With a strong focus on scientific excellence and patient-centric innovation, Hansa continues to push the boundaries of biopharmaceutical research and development.
Hansa Biopharma has increased its registered share capital and the number of shares and votes. The company issued 2,305,260 new ordinary shares, raising the number of votes by the same amount and increasing the share capital by SEK 2,305,260.
Additionally, all 2,362,445 issued class C shares were converted into ordinary shares to deliver ordinary shares to participants in Hansa's incentive programs and to cover social contributions resulting from these programs.
As of June 28, 2024, Hansa Biopharma's total number of registered shares stands at 67,814,241, all of which are ordinary shares. Correspondingly, the number of votes also totals 67,814,241, and the registered share capital amounts to SEK 67,814,241.
Hansa Biopharma (HNSA) has completed the randomization phase in its pivotal Phase 3 US ConfIdeS trial. This trial evaluates the efficacy of imlifidase in kidney transplantation for highly sensitized patients. The trial involves 64 patients and is conducted across 24 US sites. The primary endpoint is kidney graft function at 12 months, measured by eGFR. Data from this trial will support a Biologic License Application (BLA) to the FDA, expected in H2 2025. Imlifidase, already conditionally approved in Europe under IDEFIRIX® for similar indications, is also being explored for autoimmune diseases and as a pre-treatment in gene therapy.
Hansa Biopharma (NASDAQ: HNSA) announced it will present data on its antibody-cleaving enzyme imlifidase at the 2024 American Transplant Congress (ATC). Imlifidase targets IgG and inhibits the IgG-mediated immune response, aiding highly sensitized kidney transplant patients. Key presentations include the reestablishment of COVID-specific IgG antibodies and long-term clinical outcomes of imlifidase. Hansa has conditional European approval for imlifidase under the name IDEFIRIX® and plans to submit a Biologic License Application to the US FDA in 2025. The enzyme is also being studied for pre-treating gene therapy in rare diseases and certain autoimmune conditions.
FAQ
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