Søren Tulstrup, CEO and President,
Imlifidase has conditional marketing approval in
Key abstracts at ATC include:
Abstract Title and Location | Presentation Details |
Reestablishment of COVID-Specific IgG Antibodies After Imlifidase Treatment Abstract B058 Poster Hall‚ Exhibit Hall A‚ Level 2 |
Poster Presentation Sunday 2 June |
A Phase II Study Investigating DSA Rebound in Highly Sensitized Living Donor Kidney Transplant Recipients Treated with Imlifidase 107-AB‚ Level 1 |
Late Breaking Abstracts: Clinical Rapid Fire Oral Abstract Monday 3 June |
Imlifidase for Highly Sensitized Kidney Transplant Recipients with a Positive Crossmatch Against a Deceased Donor: Results of Kidney Transplantations Performed in Accordance to the French Guidelines Abstract D092 Poster Hall‚ Exhibit Hall A‚ Level 2 |
Poster Presentation Tuesday 4 June |
Five Years of Imlifidase: Clinical Outcomes and Donor-Specific Antibodies 118- |
Rapid Fire Oral Abstract Tuesday 4 June |
Long-Term Follow Up of Imlifidase Desensitized Kidney Transplant Recipients: 5 Year Pooled Analysis 108-AB‚ Level 1 | Rapid Fire Oral Abstract |
-- ENDS ---
Contacts for more information
E: media@hansabiopharma.com
E: ir@hansabiopharma.com
Notes to editors
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.1 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.2,3 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.2,3 Across the
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.6 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.
Imlifidase has conditional marketing approval in
Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).7 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.8 Once they are inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection.
The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.7,9-11
Full product information can be accessed via the initial Summary of Product Characteristics found here.
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.12 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.12 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 80,000 kidney patients on transplant waiting lists across the
About
©2024 Hansa Biopharma.
References
- Eurostam Report (A
Europe -wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reporting. - Redfield R, et al. Nephrol Dial Transplant 2016; 31:1746-1753
- Lonze BE, et al. Ann Surg 2018; 268(3):488-496
- EDQM. (2020). International figures on donation and Transplantation 2019
-
SRTR Database and individual assessments of allocation systems 6_
European Medicines Agency . Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf. European Medicines Agency . Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.- Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
-
Manook M, et al.
Lancet 2017; 389(10070):727-734. - Winstedt L, et al. PLoS One 2015; 10(7): e013201
- Lorant T, et al. Am J Transplant 2018;18(11):2752-2762.
-
Jordan SC, et al. Transplantation
October 21 2020 - volume online first issue NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.- Newsletter Transplant. Available at: https://freepub.edqm.eu/publications.
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-to-present-data-at-2024-american-transplant-congress-annual-meeting,c3984587
https://mb.cision.com/Main/1219/3984587/2808530.pdf
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