LUND, Sweden, March 11, 2025 /PRNewswire/ -- Hansa Biopharma AB, 'Hansa' (Nasdaq Stockholm: HNSA), announced today that it has completed enrolment of its 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study, an open-label Phase 3 confirmatory study in Europe investigating the one-year patient and graft survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with imlifidase. Imlifidase is the Company's first generation, first-in-class, one-time treatment, conditionally approved in Europe as desensitization treatment in kidney transplantation with the brand name IDEFIRIX®.1 Imlifidase is also being evaluated in late-stage trials in autoimmune diseases where immunoglobulin G (IgG) antibodies are a driver of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies.

LUND, Sweden, March 11, 2025 /PRNewswire/ -- Hansa Biopharma AB, 'Hansa' (Nasdaq Stockholm: HNSA), announced today that it has completed enrolment of its 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study, an open-label Phase 3 confirmatory study in Europe investigating the one-year patient and graft survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with imlifidase. Imlifidase is the Company's first generation, first-in-class, one-time treatment, conditionally approved in Europe as desensitization treatment in kidney transplantation with the brand name IDEFIRIX®.1 Imlifidase is also being evaluated in late-stage trials in autoimmune diseases where immunoglobulin G (IgG) antibodies are a driver of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies.

LUND, Sweden, Jan. 7, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced that management will attend the 43rd Annual J.P. Morgan Healthcare Conference. If you are interested in a meeting, please contact Hansa Biopharma at ir@hansabiopharma.com.

The Company has achieved several key milestones in the last 12-months across its three key therapeutic areas: Autoimmune, Gene Therapy and Transplantation.  

In Autoimmune, the company announced positive data from the 15-HMedIdeS-09 Phase 2 trial in Guillain Barre Syndrome (GBS) and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) demonstrating the potential of imlifidase, the Company's first-generation IgG cleaving molecule, to address a significant unmet need in GBS. Additionally, the GOOD-IDES-02 (Phase 3 trial in anti-GBM) completed enrolment and positive results from the NICE-01 Phase 1 trial and additional 12-month analysis for HNSA-5487, the Company's second-generation IgG cleaving molecule, demonstrated rapid and robust IgG reduction and redosing potential.

LUND, Sweden, Jan. 7, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced that management will attend the 43rd Annual J.P. Morgan Healthcare Conference. If you are interested in a meeting, please contact Hansa Biopharma at ir@hansabiopharma.com.

The Company has achieved several key milestones in the last 12-months across its three key therapeutic areas: Autoimmune, Gene Therapy and Transplantation.  

In Autoimmune, the company announced positive data from the 15-HMedIdeS-09 Phase 2 trial in Guillain Barre Syndrome (GBS) and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) demonstrating the potential of imlifidase, the Company's first-generation IgG cleaving molecule, to address a significant unmet need in GBS. Additionally, the GOOD-IDES-02 (Phase 3 trial in anti-GBM) completed enrolment and positive results from the NICE-01 Phase 1 trial and additional 12-month analysis for HNSA-5487, the Company's second-generation IgG cleaving molecule, demonstrated rapid and robust IgG reduction and redosing potential.

LUND, Sweden, Dec. 17, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), today announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS.

LUND, Sweden, Dec. 17, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA), today announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS.

Data from the trial is expected to be shared in 2025

LUND, Sweden, Dec. 5, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) today announced it has completed the enrolment of patients in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually.1 Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA). Enrolment completion was originally planned for 2025.

Data from the trial is expected to be shared in 2025

LUND, Sweden, Dec. 5, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) today announced it has completed the enrolment of patients in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually.1 Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA). Enrolment completion was originally planned for 2025.

The trial will be conducted in patients with pre-existing anti-AAV antibodies which limit use of gene therapy treatment.

LUND, Sweden and EVRY, France, Dec. 3, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) and Genethon, a pioneer and a leader in gene therapy research and development for rare genetic diseases, today announced initiation of GNT-018-IDES, a Phase 2 trial in patients with Crigler-Najjar syndrome with pre-existing antibodies against adeno-associated virus (AAV) vectors. The trial will evaluate the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase, Hansa's first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV serotype 8 (AAV8).

The trial will be conducted in patients with pre-existing anti-AAV antibodies which limit use of gene therapy treatment.

LUND, Sweden and EVRY, France, Dec. 3, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) and Genethon, a pioneer and a leader in gene therapy research and development for rare genetic diseases, today announced initiation of GNT-018-IDES, a Phase 2 trial in patients with Crigler-Najjar syndrome with pre-existing antibodies against adeno-associated virus (AAV) vectors. The trial will evaluate the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase, Hansa's first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV serotype 8 (AAV8).