Virtual Investor Event
Join Hansa Biopharma for an investor event featuring two KOLs discussing unmet need and current treatment landscape for Guillain-Barré syndrome (GBS).
June 16, 14:00 CEST/8:00 AM ET
Register and attendApproximate number of patients across the U.S. and Europe waiting for a kidney transplant.1
New patients are added to the kidney transplant waiting list each year.1
Patients on the waiting lists who are classified as highly sensitized.2
Transplantation is a procedure that can restore essential body functions. It often involves implanting biological material such as cells, tissues, or organs, from a donor into a recipient’s body. The transplantation of a donor organ exposes the recipient’s body to biological foreign antigens that lead to acute and chronic immune attacks by the recipient’s immune system. This can damage the organ and lead to its rejection.
Immunosuppression therapies are necessary to counteract both the acute and chronic immune attack and preserve the function and survival of the donor organ.
Highly sensitized kidney transplant patients face extended time on transplant waiting lists due to a broad reactivity against human leukocyte antigens (HLA) that makes the identification of an immunologically suitable donor organ more difficult.2,3
Kidney transplantation is a lifesaving treatment for patients with kidney failure, also known as end-stage renal disease (ESRD), a serious condition affecting almost 2.5 million patients worldwide.1
People who progress to ESRD will require renal replacement therapy, which involves either dialysis or kidney transplantation. Patients dependent on dialysis may need up to hours of treatment several times a week or continuous therapy daily, which for most patients results in significantly impaired qualify of life. Receiving a transplant is life-changing, offering a better quality of life at lower societal cost compared to dialysis.4
Our commitment
Hansa Biopharma is currently conducting an open-label, controlled, randomized Phase 3 trial (ConfIdeS) evaluating 12-month kidney function in highly sensitized kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care.
For more information: NCT04935177
Imlifidase, marketed as IDEFIRIX®, was granted conditional authorization by the European Commission in the European Union (EU)/EAA and the United Kingdom (UK) as the first desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.5
Acute antibody-mediated rejection (AMR) is one of the biggest risks for patients after a transplant. By transplanting organs or tissues from one individual to another, a process known as allogeneic transplantation, the recipient’s immune system is exposed to foreign antigens.
As part of a natural immune response against the graft, the immune system can develop donor-specific antibodies, or DSAs, that are specific to the transplant. These DSAs can cause an AMR that may eventually result in an unsuccessful transplantation.
In kidney transplantation, AMR occurs in approximately 5-7%6 of patients and is a main cause for transplant failure (graft loss). There are approximately 70,000 kidney patients on transplant waiting lists across the European Union (EU) and the United Kingdom (UK) and approximately 400,000 who currently live with a kidney transplant.7
Our commitment
In 2023 we completed a phase 2 trial investigating the safety and efficacy of imlifidase in reducing donor-specific antibodies (DSAs) in patients with antibody mediated rejection (AMR) following a kidney transplant.
For more information: NCT03897205
References
1. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2024
2.Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024. Accessed: May 2024.
3. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.
4. Axelrod DA, et al. An economic assessment of contemporary kidney transplant practice. Am J Transplant. 2018 May;18(5):1168-1176. doi: 10.1111/ajt.14702. Epub 2018 Mar 31. PMID: 29451350.
5. European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/IDEFIRIX. Accessed: May 2024.
6. Puttarajappa C, et al. Antibody-mediated rejection in kidney transplantation: a review. J Transplant. 2012;2012:193724. doi: 10.1155/2012/193724.
7. Global Observatory on Donation and Transplantation (GODT) data, produced by the WHO-ONT collaboration.