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).

LUND, Sweden, Oct. 30, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) today announced it will attend Truist Securities BioPharma Symposium on November 7 in New York, NY. Hitto Kaufmann, Chief R&D Officer at the Company will participate in a panel discussion entitled, 'Inflammatory Insights:  Advancing Novel Therapeutics Across Autoimmune and Inflammatory Indications' on Thursday November 7th from 10:30 to 11:20 AM EST.

Recently Hansa conducted a 12-month follow up analysis of data from the NICE-01 trial of HNSA-5487, the company's next generation molecule. The analysis demonstrates that HNSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile.

LUND, Sweden, Oct. 30, 2024 /PRNewswire/ -- Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) today announced it will attend Truist Securities BioPharma Symposium on November 7 in New York, NY. Hitto Kaufmann, Chief R&D Officer at the Company will participate in a panel discussion entitled, 'Inflammatory Insights:  Advancing Novel Therapeutics Across Autoimmune and Inflammatory Indications' on Thursday November 7th from 10:30 to 11:20 AM EST.

Recently Hansa conducted a 12-month follow up analysis of data from the NICE-01 trial of HNSA-5487, the company's next generation molecule. The analysis demonstrates that HNSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile.

LUND, Sweden, Oct. 7, 2024 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or the "Company") (NASDAQ STOCKHOLM: HNSA), today announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, the Company's next generation immunoglobulin G (IgG)-cleaving molecule, assessing IgG recovery, immunogenicity and redosing potential.

In the NICE-01 trial, HNSA-5487 demonstrated rapid and highly robust reduction of IgG levels by more than 95 percent within a few hours post treatment. In a 12-month follow up analysis IgG levels returned to normal range six months after initial dosing. This confirms that HNSA-5487 mirrors the extremely high efficacy of imlifidase, the Company's first-generation IgG-cleaving enzyme, in reducing total IgG levels. No serious adverse events were observed and as previously communicated HNSA-5487 is safe and well tolerated.

LUND, Sweden, Oct. 7, 2024 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or the "Company") (NASDAQ STOCKHOLM: HNSA), today announced positive results from a 12-month follow up analysis from the NICE-01 trial of HNSA-5487, the Company's next generation immunoglobulin G (IgG)-cleaving molecule, assessing IgG recovery, immunogenicity and redosing potential.

In the NICE-01 trial, HNSA-5487 demonstrated rapid and highly robust reduction of IgG levels by more than 95 percent within a few hours post treatment. In a 12-month follow up analysis IgG levels returned to normal range six months after initial dosing. This confirms that HNSA-5487 mirrors the extremely high efficacy of imlifidase, the Company's first-generation IgG-cleaving enzyme, in reducing total IgG levels. No serious adverse events were observed and as previously communicated HNSA-5487 is safe and well tolerated.