This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft.

Start Date01 Nov 2024

Sponsor / Collaborator

Fundació Clinic per a la Recerca Biomedica

NCT06518005 / Not yet recruitingPhase 2IIT

An Open-label, Phase 2 Trial to Evaluate the Efficacy and Safety of a Single Intravenous Administration of GNT0003 (an Adeno-associated Viral (AAV) Vector Expressing the UGT1A1 Transgene) Following Imlifidase Pre-treatment in Adult Participants With Severe Crigler-Najjar Syndrome (CNS) Requiring Daily Phototherapy and Presenting Pre-existing Anti-AAV8 Antibodies

Clinical trial rationale:
CNS is an ultra-rare (<1/1 million newborns), autosomal recessive disorder of bilirubin conjugation caused by mutation in the gene coding for uridine 5'-diphosphate glucuronosyltransferase (UGT1A1), that causes the accumulation of neurotoxic unconjugated bilirubin (UCB).
Reduction of UCB is managed with phenobarbital in mild CNS, and daily phototherapy in severe CNS.
There is no authorized curative medical treatment for CNS. Liver transplantation is currently the only curative treatment for severe CNS.
GNT0003 is a genetically modified recombinant (r) viral vector composed of the AAV8 viral capsid carrying the UGT1A1 transgene which aims to correct the dysfunction of the mutated gene by achieving durable expression of a functional copy of the affected gene.
Imlifidase (IgG-degrading enzyme) has demonstrated its efficacy in highly sensitized adult kidney transplant patients.
To give participants with pre-existing anti-AAV8 antibodies access to gene therapy treatments, this trial aims to demonstrate the safety and efficacy of GNT0003 following imlifidase pre-treatment in adult participants with severe CNS requiring daily phototherapy and presenting with pre-existing anti-AAV8 antibodies.
Primary objective: to assess efficacy of a single intravenous administration of GNT0003 following imlifidase pre-treatment in participants with severe CNS requiring phototherapy and pre-existing AAV8 antibodies
Secondary objective: to collect data on safety and tolerability of GNT0003 and imlifidase, efficacy of imlifidase, pharmacokinetic and pharmacodynamic profile of GNT0003, and Quality of Life.
The trial will include 3 parts:
* A baseline period for at least 3 months
* A treatment period
* A follow-up period:
* Initial post-treatment follow-up over 48 weeks
* Long-term follow-up for 4 additional years
This trial will be conducted in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice and the Declaration of Helsinki. Participants must be consented using the approved Informed Consent Form before any procedures specified in the protocol are performed.

Start Date15 Oct 2024

Sponsor / Collaborator

Genethon

[+1]

NCT06241950 / Active, not recruitingPhase 1

An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in Association With Imlifidase in Subjects With Duchenne Muscular Dystrophy With Pre-existing Antibodies to rAAVrh74

This is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with DMD with pre-existing antibodies to rAAVrh74 over a period of 104 weeks.

Start Date29 Jan 2024

Sponsor / Collaborator

Sarepta Therapeutics, Inc.

[+1]

100 Clinical Results associated with Imlifidase

100 Translational Medicine associated with Imlifidase

100 Patents (Medical) associated with Imlifidase

226

Literatures (Medical) associated with Imlifidase

01 Feb 2024·Transplantation

Imlifidase Desensitization in HLA-incompatible Kidney Transplantation: Finding the Sweet Spot

Review

Author: de Weerd, Annelies E ; Heidt, Sebastiaan ; van de Wetering, Jacqueline ; Reinders, Marlies E J ; Roelen, Dave L ; Betjes, Michiel G H

Imlifidase, derived from a Streptococcus pyogenes enzyme, cleaves the entire immunoglobulin G pool within hours after administration in fully cleaved antigen-binding and crystallizable fragments. These cleaved fragments can no longer exert their antibody-dependent cytotoxic functions, thereby creating a window to permit HLA-incompatible kidney transplantation. Imlifidase is labeled, in Europe only, for deceased donor kidney transplantation in highly sensitized patients, whose chances for an HLA-compatible transplant are negligible. This review discusses outcomes of preclinical and clinical studies on imlifidase and describes the phase III desensitization trials that are currently enrolling patients. A comparison is made with other desensitization methods. The review discusses the immunological work-up of imlifidase candidates and especially the “delisting strategy” of antigens that shift from unacceptable to acceptable with imlifidase desensitization. Other considerations for clinical implementation, such as adaptation of induction protocols, are also discussed. Imlifidase cleaves most of the currently used induction agents except for horse antithymocyte globulin, and rebound of donor-specific antibodies should be managed. Another consideration is the timing and interpretation of (virtual) crossmatches when bringing this novel desensitization agent into the clinic.

20 Dec 2023·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Using imlifidase to elucidate the characteristics and importance of anti-GBM antibodies produced after start of treatment

Article

Author: Hellmark, Thomas ; Segelmark, Mårten ; Andersson, Fanny ; Tyrberg, Linnéa ; Uhlin, Fredrik

ABSTRACT:

Background:

Autoantibodies are common in glomerulonephritis, but the clinical benefit of rapid elimination has not been determined, even in anti-glomerular basement membrane (GBM) disease. Even less is known about the importance of autoantibody characteristics, including epitope specificity and immunoglobulin G (IgG) subclass distribution. We aimed to address this by characterizing the autoantibody profile in anti-GBM patients: we utilized samples from the GOOD-IDES-01 (treating GOODpasture's disease with Imunoglobulin G Degrading Enzyme of Streptococcus pyogenous) (ClinicalTrials.gov identifier: NCT03157037) trial , where imlifidase, which cleaves all IgG in vivo within hours, was given to 15 anti-GBM patients.

Methods:

In the GOOD-IDES-01 trial, plasmapheresis was (re)started if anti-GBM antibodies rebounded. Serum samples were collected prospectively for 6 months and analyzed for anti-GBM epitope specificity using recombinant constructs of the EA and EB epitopes, IgG subclass using monoclonal antibodies, and anti-neutrophil cytoplasmic antibodies (ANCA). The results were correlated with clinical data.

Results:

Patients with a rebound (n = 10) tended to have lower eGFR at 6 months (11 vs 34 mL/min/1.73 m2, P = .055), and patients with dialysis at 6 months had a higher EB/EA ratio at rebound (0.8 vs 0.5, P = .047). Moreover, two patients demonstrated increasing epitope restriction and several patients displayed a shift in subclass distribution at rebound. Six patients were double positive for ANCA. ANCA rebound was seen in 50% of patients; only one patient remained ANCA positive at 6 months.

Conclusions:

In this study, rebound of anti-GBM antibodies, especially if directed against the EB epitope, was associated with a worse outcome. This supports the notion that all means should be used to eliminate anti-GBM antibodies. In this study ANCA was removed early and long-term by imlifidase and cyclophosphamide.

01 Dec 2023·Journal of translational autoimmunity

Impact of imlifidase treatment on immunoglobulins in an HLA-hypersensitized lupus nephritis patient with anti-SSA/SSB antibodies after kidney transplantation: A case report

Article

Author: Milhès, Jean ; Renaudineau, Yves ; Carlé, Caroline ; Del Bello, Arnaud ; Kamar, Nassim ; Bouthemy, Charlène ; Marion, Olivier ; Congy-Jolivet, Nicolas ; Puissant, Benedicte

Bacterial recombinant cysteine protease Ides (imlifidase, Idefirix®, Hansa Biopharma) is used to prevent humoral transplant rejection in highly HLA-sensitized recipients, and to control IgG-mediated autoimmune diseases. We report the case of a 51 years old woman suffering from lupus nephritis with end stage kidney disease, grafted for the second time and pre-treated with imlifidase. The patient was HLA-hypersensitized (calculated Panel Reactive Antibodies [Abs], cPRA>99 %) and has three preformed Donor Specific Antibodies (DSA). Circulating immunoglobulins were monitored at initiation (0, 6, 36, 72 and 96 h), and at Ab recovery one and two months following imlifidase injection. From baseline, the higher depletion was reported after 36h for total IgG (-75 %) and IgG subclasses (-87 % for IgG1, IgG2 and IgG3, -78 % for IgG4), while no significant impact on IgA and IgM was observed. Anti-SSA 60 kDa and anti-SSB auto-Abs quickly decreased after imlifidase injection (-96 % for both after 36 h) as well as post-vaccinal specific IgG (-95 % for tetanus toxoid, -97 % for pneumococcus and -91 % for Haemophilus influenzae Abs after 36 h). At the Ab recovery phase, total IgG and anti-SSA60/SSB Abs reached their initial level at two months. Regarding alloreactive Abs, anti-HLA Abs including the three DSA showed a dramatic decrease after injection with 100 % depletion from baseline after 36 h as assessed by multiplex single bead antigen assay, leading to negative crossmatches using both lymphocytotoxicity (LCT) and flow cell techniques. DSA rebound at recovery was absent and remained under the positivity threshold (MFI = 1000) after 6 months. The findings from this case report are that imlifidase exerts an early depleting effect on all circulating IgG, while IgG recovery may depend in part from imlifidase's capacity to target memory B cells.

News (Medical) associated with Imlifidase

18 Jul 2024

·www.prnewswire.com

Hansa Biopharma Reports Second Quarter 2024 Financial Results and Business Update

LUND, Sweden, July 18, 2024 /PRNewswire/ -- Hansa Biopharma today announced its first half and second quarter 2024 financial results and business update. Søren Tulstrup, President and CEO, Hansa Biopharma said: "For the third consecutive quarter, Hansa Biopharma delivered solid IDEFIRIX® sales performance driven by continued utilization of IDEFIRIX in key transplant centers across all major European markets. Additionally, we continued to progress key trials across the pipeline. Notably, we completed randomization of all patients in ConfIdeS, our pivotal Phase 3 US trial in kidney transplantation, and look forward to communicating data in the second half of 2025 with an expected Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA). Also, our Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease and the European Post Authorization Efficacy Study (PAES) in kidney transplant have both increased enrollment and remain on track. Looking ahead, the Company has several important milestones in the second half, including further analysis of data from the Phase 1 study of HNSA-5487, the Company's second-generation IgG cleaving enzyme designed to be re-dosed." Financial Performance The Company delivered strong financial performance for the third consecutive quarter with total revenue of 54.2 MSEK. Of this, 47.1 MSEK is attributed to IDEFIRIX sales. This excludes the impact of an approximate 20 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in Europe in 2020. After accounting for this provision, total IDEFIRIX product sales were 27.2 MSEK. Sales performance was primarily driven by continued expansion of IDEFIRIX in key European markets. To date, the Company has secured reimbursement in 14 European markets. In Q2 2024, the Company completed a directed share issue, raising gross proceeds of 372 MSEK (US $34.6M) primarily from high-quality international healthcare specialist investors. Pipeline Progress Progress across the pipeline included the completed randomization in the ConfIdeS pivotal Phase 3 US trial in kidney transplantation, further enrollment in the European Post Approval Efficacy Study in kidney transplantation (70 percent) with expected completion by 2025, and continued enrollment (70 percent) in the GOOD-IDES-12 Phase 3 trial in anti-GBM disease with data readout in 2025. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, July 18, 2024, at 14:00 CET / 8:00 am EST. The event will be hosted by Søren Tulstrup, President and CEO, Matthew Shaulis, Chief Commercial Officer and US President, Evan Ballantyne, Chief Financial Officer, and Hitto Kaufmann, Chief R&D Officer. The presentation will be held in English. Slides used in the presentation will be live on the company website during the call under "Events & Presentations" and will also be made available online after the call. Link to presentation To participate in the telephone conference, please use the dial-in details provided below: Sweden: +46 812 410 952 United Kingdom: +44 203 769 6819 United States: +1 646 787 0157 Participant access code: 765135 The webcast will be available on For the full financial calendar and list of events in 2024 please visit This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. For more information: Evan Ballantyne, CFO E: [email protected] Stephanie Kenney, VP Global Corporate Affairs E: [email protected] About Hansa Biopharma Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at hansabiopharma.com. This information was brought to you by Cision The following files are available for download:

Financial StatementPhase 1Phase 3

31 May 2024

·www.prnewswire.com

Hansa Biopharma Completes Randomization in Pivotal Phase 3 US ConfIdeS Trial

LUND, Sweden, May 31, 2024 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or the "Company") (NASDAQ Stockholm: HNSA), today announced recruitment and randomization in its US ConfIdeS trial is complete. ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. Data from the trial is expected to support a Biologic License Application (BLA) submission under the accelerated approval pathway to the US Food and Drug Administration (FDA) in the second half of 2025. Søren Tulstrup, President and CEO, Hansa Biopharma said, "The randomization of 64 patients in the ConfIdeS trial is an important step in bringing imlifidase to the US to help address the significant unmet need faced by highly sensitized kidney transplant patients. Our hope is that the ConfIdeS trial will help further validate the role imlifidase may play as a desensitization treatment that enables HLA-incompatible kidney transplantation. We look forward to sharing the data from the ConfIdeS trial in due course." The ConfIdeS trial is evaluating kidney function in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. A total of 24 US sites are participating in the trial and its primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate). Imlifidase has been granted conditional marketing approval in Europe under the trade name IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Imlifidase is also being studied in autoimmune conditions including anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barré syndrome (GBS) and as a pre-treatment to gene therapy in rare disease patients with pre-existing antibodies. This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 13:30 CEST on 31 May 2024. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] 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 U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.4,5 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 Europe and is marketed under the trade name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch 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.6 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.6 Imlifidase is an effective 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 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study. 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 170,000 kidney patients on transplant waiting lists across the U.S., European Union and United Kingdom.13 About Hansa Biopharma Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa Biopharma has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma has a rich and expanding research and development program based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2024 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. References Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at . Redfield RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/ OPTN/SRTR 2022 Annual Data Report. HHS/HRSA; 2024. Accessed [May 2024]. SRTR Database and individual assessments of allocation systems European Medicines Agency. Idefirix® summary of product characteristics. Available at: . Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125 Manook M, et al. Post-listing survival for highly sensitised patients on the UK kidney transplant waiting list: a matched cohort analysis. Lancet. 2017 Feb 18;389(10070):727-734. doi: 10.1016/S0140-6736(16)31595-1. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733. 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 NIH (2018). What is kidney failure? Available at: . Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant – latest edition | Freepub (edqm.eu) [Accessed May 2024]. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB

Phase 3Clinical ResultPhase 2Drug Approval

21 May 2024

·www.prnewswire.com

Hansa Biopharma to present data at 2024 American Transplant Congress annual meeting

LUND, Sweden , May 21, 2024 /PRNewswire/ --. Hansa Biopharma, "Hansa" (NASDAQ: HNSA) (STOCKHOLM: HNSA), today announced data featuring imlifidase will be presented at the American Transplant Congress (ATC), the joint annual meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (ATS). Imlifidase is Hansa's unique antibody-cleaving enzyme that specifically targets IgG and inhibits IgG-mediated immune response.1 Søren Tulstrup, CEO and President, Hansa Biopharma, said: "ATC is a valuable opportunity for Hansa to share the latest science and data around imlifidase and its role in enabling transplantation for those patients who are highly sensitized. We are excited to attend ATC and showcase the progress we are making across our Transplantation therapy area and these data underscore our continued commitment to advancing innovative new approaches to transplantation care." Imlifidase has conditional marketing approval in Europe under the trade name IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The Company is conducting an open label, randomized controlled Phase 3 trial in the US in kidney transplantation and plans to submit a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) in 2025. The molecule is also being studied as a pre-treatment to gene therapy in rare disease patients with pre-existing antibodies and in autoimmune conditions including anti-GBM and Guillain Barre Syndrome (GBS). Key abstracts at ATC include: Contacts for more information Stephanie Kenney, VP Global Corporate Affairs E: [email protected] Evan Ballantyne, CFO E: [email protected] 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 U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.4,5 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 Europe and is marketed under the trade name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patiensts who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.6 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.6 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 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study. 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 European Union and United Kingdom.13 About Hansa Biopharma Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa Biopharma has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma has a rich and expanding research and development program based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2024 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. References Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at . 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: . European Medicines Agency. Idefirix® summary of product characteristics. Available at: . 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: . Newsletter Transplant. Available at: . This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB

Phase 3Phase 2Drug ApprovalImmunotherapy

100 Deals associated with Imlifidase

External Link

KEGG	Wiki	ATC	Drug Bank
D11470	-	L04AA41	DB15258

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Renal transplant rejection	EU	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	IS	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	LI	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	NO	Hansa Biopharma AB	25 Aug 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anti-Glomerular Basement Membrane Disease	Phase 3	US	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	CZ	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	DK	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	FR	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	DE	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	IT	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	NL	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	ES	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	SE	Hansa Biopharma AB	22 Dec 2022
Anti-Glomerular Basement Membrane Disease	Phase 3	GB	Hansa Biopharma AB	22 Dec 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03897205 (16-HMedIdes-12, CTgov)	Phase 2	Renal transplant rejection	30	Imlifidase (Imlifidase)	jmbuqiuzth(csonfhuqpg) = tpltjxtmbc qiwteisbhv (pjodxfdetz, zhhoqszdko - qnzktqzvfx) View more	-	28 Feb 2024
				Plasma Exchange (Plasma Exchange)	jmbuqiuzth(csonfhuqpg) = rmtijyyawe qiwteisbhv (pjodxfdetz, wxlfaxiuyk - ndcqgpimxs) View more
NCT03897205 (16-HMedIdes-12, PRNewswire) Manual	Phase 2	AMR Syndrome	30	imlifidase	iycbpdhgrd(qoursifhqk) = oceeqqtbcj bfotsuatha (dasmizphkg ) View more	Positive	14 Dec 2023
				standard of care	iycbpdhgrd(qoursifhqk) = hxepdmdkyp bfotsuatha (dasmizphkg ) View more
NCT03943589 (15-HMedIdeS-09, Biospace) Manual	Phase 2	Guillain-Barre Syndrome	-	imlifidase+ intravenous immunoglobulin	fdzuyarwak(inhqbciyuh) = Imlifidase was safe and well tolerated lpxfcfrmpe (kvheeanboa ) View more	Positive	07 Dec 2023
NCT03897205 (Biospace) Manual	Phase 2	Graft Rejection	30	Imlifidase	qovzfqohcs(ndpvprfjoz) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study bydcqoqmdt (rlfzpggolg )	Positive	28 Nov 2022
				plasma exchange
NCT02790437 (Pubmed \| Am J Transplant) Manual	Phase 2	Renal transplant rejection	39	Imlifidase (AMR+)	nklawbsunz(khdpyygobm) = fswhsowevp ctaqzqxrtz (jhoyipgeuz ) View more	Positive	01 Dec 2021
				Imlifidase (AMR-)	nklawbsunz(khdpyygobm) = zhkmobpejv ctaqzqxrtz (jhoyipgeuz ) View more
NCT02790437 (Highdes, Pubmed \| Transplantation)	Phase 2	-	19	Imlifidase	rdrgksnkdw(bymrwemyfh) = consistent with previous studies lpctmhxcwc (lirhbwehes ) View more	-	21 Oct 2020
NCT03157037 (GOOD-IDES-01, Corporate Publications) Manual	Phase 2	Anti-Glomerular Basement Membrane Disease	15	imlifidase	aqpwscdtiy(uvszqksnwe) = kwswryvgai zqhktuwnig (ibkdyygrsv ) View more	Positive	24 Sep 2020
NCT02854059 (CTgov)	Phase 2	Purpura, Thrombotic Thrombocytopenic	2	IdeS (0.25 mg/kg) (Treatment IdeS (0.25 mg/kg))	robujqlriv(fmrnfmrkky) = uqhernygbl eoylrijnob (ccsddoglpx, cletbzrrig - zdtgcgfyna) View more	-	13 Sep 2019
				IdeS (0.50 mg/kg) (Treatment IdeS (0.50 mg/kg))	ygnxgqjutg(caleobddrv) = frzhucycpe tuctaxqudr (awwtzhlujx, vyclyfyigb - rgfesgjotf) View more
NCT02224820 (Pubmed \| Am J Transplant)	Phase 2	Chronic Kidney Diseases	8	IdeS (imlifidase) 0.12 mg/kg ×2	wvtksihuil(mwfifapkqb) = abolished edwbraeueg (ystaqrowdm )	-	01 Nov 2018
				IdeS (imlifidase) 0.25 mg/kg ×1
NCT02224820 (CTgov)	Phase 2	Chronic Kidney Diseases	8	IdeS	yxmeukopil(ukdvjlplat) = gptblinhcd gcdiamsaoi (cdmnbuajdb, ayshmrykjd - olfuuoboqe) View more	-	23 May 2016

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis