Hansa Biopharma to present at 2024 American Transplant Congress

Lund, Sweden, May 21, 2024 -- Hansa Biopharma, known as Hansa, has unveiled new data on its pioneering enzyme, imlifidase, which will be showcased at the upcoming American Transplant Congress (ATC). The ATC is a collaborative annual conference held by the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (ATS). Imlifidase, an innovative enzyme developed by Hansa, specifically targets and cleaves IgG antibodies, effectively inhibiting immune responses mediated by these antibodies.

Søren Tulstrup, the CEO and President of Hansa Biopharma, emphasized the significance of the ATC event for the company. He stated that it offers a crucial platform for Hansa to present the latest scientific research and data regarding imlifidase, especially in the context of its role in facilitating transplants for highly sensitized patients. Tulstrup expressed enthusiasm about attending the ATC, highlighting the company's commitment to advancing new transplantation care methodologies.

In Europe, imlifidase has received conditional marketing approval under the brand name IDEFIRIX® for use in desensitizing highly sensitized adult kidney transplant patients who have a positive crossmatch with available deceased donors. Hansa is also conducting an open-label, randomized controlled Phase 3 trial in the United States for kidney transplantation and plans to submit a Biologic License Application (BLA) to the FDA in 2025. Additionally, imlifidase is being tested as a pre-treatment for gene therapy in patients with rare diseases who have pre-existing antibodies, and in autoimmune conditions such as anti-GBM and Guillain-Barré Syndrome (GBS).

Highly sensitized patients are individuals with pre-formed antibodies, known as donor-specific antibodies (DSAs), that broadly react against human leukocyte antigens (HLAs). These antibodies can lead to tissue damage and potentially cause transplant rejection. Finding compatible donor organs for highly sensitized patients is particularly challenging, resulting in longer wait times and increased mortality risk. Approximately 10-15% of patients on transplant waiting lists in the U.S. and Europe fall into this highly sensitized category.

Imlifidase, derived from the bacterium Streptococcus pyogenes, works by rapidly cleaving IgG antibodies and inhibiting their activity shortly after administration. This innovative approach provides a window of opportunity for transplantation before the body can produce new IgG antibodies. By the time the body begins to regenerate these antibodies, patients would already be on post-transplant immunosuppressive therapy to prevent organ rejection.

The efficacy and safety of imlifidase have been demonstrated in several clinical trials. Four Phase 2 open-label, single-arm, six-month clinical trials showed promising results. Hansa continues to gather clinical evidence and plans to submit further data from ongoing observational follow-up studies and post-approval efficacy studies.

Kidney failure, or End-Stage Renal Disease (ESRD), occurs when kidney function drops below 15%. Affecting nearly 2.5 million individuals worldwide, ESRD poses significant health challenges. For those suitable, a kidney transplant is the preferred treatment as it offers improved survival rates and quality of life, compared to long-term dialysis. Approximately 80,000 kidney patients are currently on transplant waiting lists across the European Union and the United Kingdom.

Hansa Biopharma, based in Lund, Sweden, is a biopharmaceutical company dedicated to developing and commercializing life-changing treatments for patients with rare immunological conditions. The company has made significant strides with its proprietary IgG antibody-cleaving enzyme technology, aiming to meet unmet medical needs in transplantation, autoimmune diseases, gene therapy, and cancer. Hansa Biopharma is listed on Nasdaq Stockholm under the ticker HNSA.