Hansa Biopharma Presents PAES Kidney Transplant Results
The study evaluates imlifidase in patients receiving crossmatch-positive deceased-donor kidney transplants.
Updated on Oct. 20, 2026 in Biotech
Live Poll
Are you confident in the safety and efficacy of new medical treatments for transplant patients?
Hansa Biopharma shared results from its PAES study involving 50 kidney transplant patients at the ASN Kidney Week event in Denver. The findings highlight the use of the antibody-cleaving enzyme imlifidase to facilitate successful transplants.
Why it matters
Highly sensitized patients often face significant barriers to kidney transplantation due to pre-formed antibodies that cause graft loss. This treatment aims to clear these antibodies to expand access to life-saving donor organs.
The study observed 50 patients who underwent kidney transplants using the enzyme imlifidase to clear pre-formed antibodies. This method inactivates IgG-antibodies within hours to create a temporary antibody-free window for surgery.
The players
Hansa Biopharma
Headquartered in Lund, Sweden, this biopharmaceutical company specializes in developing immunomodulatory treatments for rare diseases.
SERB Pharmaceuticals
This company is a specialty pharmaceutical firm that manages the distribution and licensing of various orphan drug treatments.
The details
Imlifidase is an antibody-cleaving enzyme derived from Streptococcus pyogenes designed to eliminate pre-formed antibodies in sensitized individuals. The company has already secured conditional marketing authorization in the European Union for the drug, known as Idefirix.
Timeline
August 25, 2020: Imlifidase received conditional marketing authorization in the European Union.
February 2026: The FDA accepted the Biologics License Application for imlifidase.
July 1, 2026: The licensing agreement between Hansa Biopharma and SERB Pharmaceuticals became effective.
October 20, 2026: Hansa Biopharma announced the presentation of the study at the ASN event.
December 19, 2026: The FDA set this date as the PDUFA action deadline for the imlifidase application.
The Tech Race
The development of antibody-cleaving enzymes represents a shift toward overcoming immunological barriers that previously rendered many patients ineligible for transplants. This innovation positions the technology against traditional, slower-acting desensitization therapies.
For the approximately 170,000 kidney patients currently awaiting a transplant, this technology could eventually increase the feasibility of finding a compatible donor. It offers a potential path forward for the 10-15% of highly sensitized patients who struggle to find a match.
The takeaway
Imlifidase represents a targeted approach to managing immune responses that prevent successful organ transplantation. If approved by regulators, it could provide a new standard of care for patients with high levels of pre-formed antibodies.
What happens next
The FDA is scheduled to issue a decision on the Biologics License Application for imlifidase by December 19, 2026.
Further reading
For more developments in this field, explore the latest news in Biotech.
More information
Review the full EU Idefirix product information for technical details.
Live Poll
Are you confident in the safety and efficacy of new medical treatments for transplant patients?
