Hansa Biopharma announces first commercial kidney transplant patient treated with Idefirix in Australia

Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced that the first commercial patient in Australia has received a living donor kidney transplant following treatment with Idefirix ® (imlifidase), consistent with the indication approved by the Therapeutic Goods Administration (TGA). " This first commercial living donor transplant patient in Australia represents an important milestone for Hansa and for patients facing significant barriers to transplantation ," said Renée Aguiar-Lucander, CEO of Hansa Biopharma. " We look forward to continued collaboration with the Australian transplant community to build experience with Idefirix across both living and deceased donor transplantations ." Patient outcomes will be documented through an established registry in Australia. Data from real-world clinical use will be collected and may contribute to future scientific publications, and help to further the understanding of the use of Idefirix in living donor transplants. Idefirix is approved in Australia as a desensitization treatment of highly sensitized adult kidney transplant candidates who have a positive cross-match against a living or deceased donor.

About highly sensitized patients Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection. The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging. The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk. Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.

About imlifidase Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix ® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive cross-match against an available deceased donor. Idefirix ® is also approved in Australia, Israel and Switzerland. Information about the trial is available at ClinicalTrials.gov: NCT04935177

About IDEFIRIX ® (imlifidase) Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive cross-match against an available deceased donor. The use of Idefirix should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients. Idefirix was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four phase 2 single-arm, studies in EU and US as well as a randomized, controlled Phase 3 study in US. Hansa is collecting further clinical evidence and will submit...