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 Date08 Nov 2024

Sponsor / Collaborator

Genethon

[+1]

NCT06461546

/ WithdrawnPhase 2IIT

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients (LIVEDES)

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 Date22 Oct 2024

Sponsor / Collaborator-

NCT06241950

/ Enrolling by invitationPhase 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

129

Literatures (Medical) associated with Imlifidase

01 Jul 2025·Transplantation Reviews

Spanish guidelines for kidney transplantation in highly sensitized patients with donor-specific anti-HLA antibodies

Review

Author: Andrés, Amado ; Mazuecos, Auxiliadora ; Ontañón, Jesús ; Álvarez, Antonia ; Coll, Elisabeth ; Diekmann, Fritz ; Crespo, Marta ; Domínguez-Gil, Beatriz ; Bestard, Oriol ; González, M Francisca ; Muro, Manuel ; Vilches, Carlos ; Fernández, Constantino ; Vega, Rocío ; Segundo, David San ; Nieto, Antonio ; Caro, José L ; Paz-Artal, Estela ; Cruzado, Josep M ; Mancebo, Esther ; Palou, Eduard

Highly sensitized patients awaiting kidney transplantation face substantial challenges due to the presence of potential donor-specific anti-HLA antibodies (DSA). These antibodies increase the risk of antibody-mediated rejection (ABMR), but also complicate their access to HLA compatible transplantation. Although advancements in allocation priority programs, such as the Spanish Program for the Access of Highly Sensitized Patients to Kidney Transplantation (PATHI), have introduced virtual crossmatching (v-XM) to streamline compatibility assessments, patients with >99,5 % virtual panel reactive antibodies (vPRA) often remain on waiting lists for extended periods with minimal chances of receiving a transplant. This article summarizes Spanish guidelines for a harmonized and comprehensive framework for the management of highly sensitized patients. These guidelines focus on strategies to facilitate transplantation in the presence of DSA, including a stepwise approach to delist HLA antigens, prioritizing those recognized as "less deleterious" antibodies, to expand transplant options while minimizing immunological risks. Conventional desensitization techniques are discussed, alongside the innovative use of imlifidase to enable transplants in particularly complex cases. Post-transplant monitoring protocols are also exposed, with a focus on early detection of antibody rebound and effective management of ABMR. Ultimately, this resource offers clinicians a structured framework to navigate the intricate challenges of kidney transplantation in high-risk populations, aiming to enhance access to life-saving procedures and improve patient outcomes.

01 Jun 2025·Analytica Chimica Acta

Online multimethod platform for comprehensive characterization of monoclonal antibodies in cell culture fluid from injection of crude sample - Incorporation of middle-up and bottom-up workflows

Article

Author: Lubbers, Karin ; Haselberg, Rob ; Wouters, Sam ; Vido, Marek ; Gargano, Andrea F G ; de Kleijne, Vera H ; Zioga, Eirini ; Somsen, Govert W ; Sadighi, Raya

BACKGROUNDDetermination of critical quality attributes (CQAs) of pharmaceutical monoclonal antibodies (mAbs) is an essential part of quality control. Commonly, for each CQA, a separate analytical method and setup is required, making assessment of multiple CQAs time-consuming and labour-intensive. This typically involves offline purification and diverse protein digestion steps, in combination with multiple liquid-chromatographic modes. We developed an integrated, fully online multidimensional platform for direct analysis of mAbs in cell culture fluid (CCF) at an intact, subunit and peptide level from a single injection.RESULTSThis paper focuses on the online middle-up and bottom-up workflows. The platform combines Protein A affinity chromatography (ProtA), immobilized enzyme reactors (IMERs), reversed-phase liquid chromatography (RPLC) and high-resolution mass spectrometry (MS) for characterization of mAbs. Online ProtA was used to isolate mAbs directly from CCF. Subsequent online digestion of isolated mAb was accomplished by IMERs featuring either the proteases IdeS or trypsin. Between ProtA and IMERs, buffer exchange and pH adjustment were achieved using a strong cation-exchange (SCX) trap column. RPLC-MS analysis of F(ab)'₂ and Fc/2 fragments obtained after IdeS digestion provided information on mAb glycoform compositions and the potential presence of PTMs and subunit variants. RPLC-MS/MS analysis of trypsin-digested peptides provided over 95 % coverage of the mAb's amino acid sequence, but also identification and localization of modifications related to e.g. oxidation and deamidation. Comparisons with established offline methods were made. The overall capacity of the system to perform intact, middle-, and bottom-up analyses in parallel from a single injection is demonstrated for an industrially-relevant mAb in CCF.SIGNIFICANCEThe developed multidimensional platform enables the simultaneous characterization of multiple fractions from a single ProtA-isolated mAb band at intact, middle-up, or bottom-up level using various LC modes at a substantially reduced analysis time.

01 Apr 2025·American Journal of Transplantation

Long-term outcomes at 5 years posttransplant in imlifidase-desensitized kidney transplant patients

Letter

Author: Lonze, Bonnie E ; Sjöholm, Kristoffer ; Lefèvre, Paola ; Vo, Ashley A ; von Zur Mühlen, Bengt ; Lorant, Tomas ; Montgomery, Robert A ; Runström, Anna ; Jordan, Stanley C ; Tollemar, Jan ; Desai, Niraj M ; Lagergren, Anna ; Legendre, Christophe ; Lundgren, Torbjörn ; Maldonado, Angela Q

News (Medical) associated with Imlifidase

24 Apr 2025

·www.prnewswire.com

Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results

Strong product sales and key progress in pipeline catalysts LUND, Sweden, April 24, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (Nasdaq Stockholm: HNSA), today announced its interim report for January-March 2025. Peter Nicklin, Chairman of the Board, Hansa Biopharma said, "In Q1, the Company delivered strong growth with total revenue of 66.3 MSEK and products sales of 65.7 MSEK. This represents a 39 percent increase as compared to Q1 2024 (47.4 MSEK). While the organ allocation market remains unpredictable and directly impacts our quarterly sales, we remain confident in our ability to significantly increase revenue year on year. In Q1, we completed enrollment in the Post Authorization Efficacy and Safety (PAES) study, secured access and reimbursement in three additional European markets, and saw growing repeat utilization of IDEFIRIX® (imlifidase) in key centers across Europe. In the second half of 2025, we anticipate several key pipeline catalysts, including data readouts from Hansa's U.S. ConfIdeS Phase 3 pivotal trial in kidney transplantation and the anti-GBM Phase 3 pivotal trial." "Also, of note, following the positive full results from the 15-HMedIdeS-09 single arm Phase 2 study in Guillain Barre Syndrome (GBS) shared in December 2024, the data is set to be presented at an upcoming medical congress. Finally, the development of the Company's next generation molecule for repeat dosing, HNSA-5487, remains on track. We recently had very positive interaction with BfArM confirming the clinical development plan for HNSA-5487 in myasthenia gravis (MG)." The Company also announced Renée Aguiar-Lucander has been appointed Chief Executive Officer effective immediately. Søren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the Company. Financial Performance Q1 2025 product sales of IDEFIRIX® totaled 65.7 MSEK representing a 39 percent increase over Q1 2024 (47.4 MSEK). Revenue for the first quarter 2025 totaled 66.3 MSEK. The addition of new sites using IDEFIRIX combined with growing repeat utilization contributed to the performance. Hansa expects to see continued strong year-on-year product sales growth despite continued quarterly product sales fluctuation due to variations in European kidney allocation systems, which impacts the availability of organs for patients. Pipeline Progress During the first quarter of 2025, Hansa completed enrolment of the 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study. The PAES study is part of the Company's obligation following conditional authorization by the European Commission for IDEFIRIX. The study is expected to read out in the second half of 2026 and is intended to support full marketing authorization in Europe. With completed enrollment, Hansa expects increased commercial utilization of imlifidase at key centers across Europe that participated in the PAES study. Following positive data from the 15-HMedIdeS-09 Phase 2 trial and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), the data has been accepted for oral presentation at an upcoming medical conference in 2025. The trial and indirect treatment comparison demonstrated imlifidase's potential to address significant unmet need in GBS. The Phase 2 trial GNT-018-IDES in collaboration with Genethon in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated vectors (AAV) continues to progress with enrolment currently ongoing. The 20-HMedIdeS-17 study (ConfIdeS) remains on track for a data readout in the second half of 2025. This pivotal Phase 3 trial is evaluating imlifidase as a potential desensitization therapy, compared to standard of care, to enable kidney transplantation in highly sensitized patients. Financial Summary Conference Call Details Hansa Biopharma will host a telephone conference today Thursday, 24 April, 2025, at 14:00 CEST / 8:00 am EDT. The event will be hosted by Peter Nicklin, Chairman of the Board, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO and Renée Aguiar-Lucander. The call will include a review of the interim results and a business and pipeline update. It 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. To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call Join the webcast here: For the full financial calendar and list of events in 2025 please visit Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] Notes to editors About Hansa Biopharma Hansa Biopharma AB 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. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next generation IgG cleaving molecule with redosing potential. 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. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Financial StatementPhase 3Executive Change

21 Mar 2025

·www.prnewswire.com

Hansa Biopharma publishes 2024 Annual and Sustainability Reports

LUND, Sweden, March 21, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (NASDAQ Stockholm: HNSA), today published its Annual and Sustainability Reports for 2024. Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "Hansa delivered several important milestones in 2024 and remains on track to advance innovative science and important new medicines. This is in large part due to the dedicated, results-driven employees, and the Company's commitment to delivering on its discovery, development and commercialization goals. In my third year as Chair of the Board of Directors, I remain inspired and excited for what is to come for Hansa." Søren Tulstrup, President and CEO, Hansa Biopharma, said, "2024 was a momentum-building year for Hansa. With year-on-year IDEFIRIX® sales growth of 83%, a successful financing round, and several critical pipeline catalysts for imlifidase and HNSA-5487, 2024 has positioned us well to advance our efforts in Autoimmune, Gene Therapy and Transplantation. 2025 promises to be an exciting and important year, marked by several data readouts and a planned BLA submission to the U.S. FDA in kidney transplantation under the accelerated approval pathway. Hansa's science-led, patients-first business model remains at the core of what we do, executed by a team of highly experienced and dedicated individuals. We remain focused on our mission to advance critical science that can address the unmet medical needs of people living with rare, immune-mediated diseases." 2024 highlights In 2024, Hansa advanced the commercialization of IDEFIRIX® (imlifidase) in Europe as a desensitization treatment for kidney transplant patients, achieving record quarterly and full year sales. The ongoing commercialization of IDEFIRIX in Europe is being driven by continued strong market access in a total of 18 markets, including the five key markets of France, Germany, Italy, Spain and the UK. A growing body of data, real-world evidence and clinical guidelines on the utilization of imlifidase as a desensitization strategy for highly sensitized kidney transplant patients has been published. The most recent guidance published in Transplant International provides specific guidelines on appropriate use of imlifidase in clinical practice to enable kidney transplants in highly sensitized patients. Preparation for commercialization in the US is progressing, with complete randomization of the pivotal Phase 3 trial - ConfIdeS - announced in May 2024. Data readout for the trial and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025. In October 2024, Hansa announced full results of the NICE-01 first in human trial and 12-month follow up analysis of HNSA-5487, demonstrating that it can robustly and rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. Initial clinical development will be focused on neuro-autoimmune disease with a well characterized role of specific autoantibodies in disease pathology and recurring acute phases - specifically, myasthenia gravis (MG). The company plans to align with regulatory authorities in the first half of 2025 on a clinical development path for HNSA-5487 in MG. In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease in December, with data readout expected in the second half of 2025. In Guillain-Barré Syndrome (GBS), Hansa announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study and an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) in December 2024. In Gene Therapy, Hansa and Genethon announced initiation of GNT-018-IDES, a Phase 2 trial sponsored by Genethon evaluating the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV8. Enrolment continues in the SRP-9001-104 Phase 1b trial evaluating the use of imlifidase as a pre-treatment to Sarepta Therapeutics Inc.'s (Sarepta) ELEVIDYS (delandistrogene moxeparvovec) gene therapy in Duchenne Muscular Dystrophy (DMD). Hansa's journey towards a more sustainable business continues Over the last three years, Hansa has continuously evolved its approach to Sustainability aligning to the changes happening within the Company and the external environment. This year's Sustainability Report outlines the continued efforts the Company has advanced and our focus for 2025. The report highlights our work to address high unmet medical need in our three core therapy areas - Autoimmune, Gene Therapy and Transplantation, as well as our continued focus on ensuring that we are operating as a transparent, ethical business. Finally, we continue to believe that a diverse, inclusive, and supportive culture is integral to the Company's success. 2024 also marked the first year Hansa conducted a Double Materiality Assessment, an opportunity to better understand the Company's impact on stakeholders and the environment as well as what opportunities influence its business. The output - a list of prioritized material topics - provided insight and perspective on the Company's sustainability strategy and areas of focus for effective risk management. Hansa uses an annual company-wide survey by Great Place to Work®, a global authority on workplace culture, to seek employee feedback with the purpose of constantly developing and refining a healthy work environment with highly engaged and motivated colleagues. In 2024, Hansa was certified as a Great Place to Work® for the fifth consecutive year, with a 95% survey participation, Read the Annual and Sustainability Reports here. This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 15:00 CET on 21 March 2025. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Stephanie Kenney, VP Global Corporate Affairs [email protected] About Hansa Biopharma Hansa Biopharma AB 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. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. 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. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Gene TherapyPhase 3Clinical Result

11 Mar 2025

·www.prnewswire.com

Hansa Biopharma completes enrolment in European Phase 3 20-HMedIdeS-19 Post Authorization Efficacy and Safety study in highly sensitized kidney transplant patients

LUND, Sweden, March 11, 2025 /PRNewswire/ -- Hansa Biopharma AB, 'Hansa' (Nasdaq Stockholm: HNSA), announced today that it has completed enrolment of its 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study, an open-label Phase 3 confirmatory study in Europe investigating the one-year patient and graft survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with imlifidase. Imlifidase is the Company's first generation, first-in-class, one-time treatment, conditionally approved in Europe as desensitization treatment in kidney transplantation with the brand name IDEFIRIX®.1 Imlifidase is also being evaluated in late-stage trials in autoimmune diseases where immunoglobulin G (IgG) antibodies are a driver of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies. The Company anticipates data readout in the second half of 2026 followed by submission to the European Medicines Agency to seek full authorization. The 20-HMedIdeS-19 or PAES study is an obligation following conditional authorization by the European Commission for IDEFIRIX® (imlifidase) in 2020. Søren Tulstrup, President and CEO, Hansa Biopharma, said, "The PAES study is an important part of Hansa's continued commitment to ensuring access to potentially lifesaving IDEFIRIX therapy for highly sensitized kidney transplant patients, as we believe that the evidence generated will support the submission for full authorization in the European Union. Those considered highly sensitized and waiting for a transplant continue to face very long wait times due to their immunological status which poses a significant barrier to finding a compatible organ. We believe the PAES study will underscore the strong efficacy and safety data supporting the use of IDEFIRIX as a desensitization treatment in the pre-transplant setting, and look forward to sharing data from the study in the second half of 2026, following the completion of a 12-month follow-up period." The PAES study is a controlled, open-label post-authorization efficacy and safety study to determine the one-year graft failure-free survival in highly sensitized kidney transplant patients with positive crossmatch against a deceased donor who received desensitization treatment with imlifidase followed by an HLA-incompatible kidney transplantation. In addition to the 50 highly sensitized adult kidney transplant patients enrolled in the study, a total of 64 patients who underwent kidney transplantation without the need for desensitization were included in a concurrent reference cohort and as part of the study design. The reference cohort was included in the trial to account for the center-to-center variability in post-transplant management of patients. The study also includes a non-comparative registry of historical data. A total of 22 sites across Europe were included. Thomas Lorant, transplant surgeon at Uppsala University and the coordinating investigator for the trial, said, "Imlifidase is transforming transplantation care for highly sensitized patients in Europe. Creating an IgG-free window by inactivating the donor-specific antibodies, it makes desensitization-enabled HLA-incompatible kidney transplantation a viable option for those considered highly sensitized and who were previously left on transplant waiting list for extended, often indefinite time. I am confident that imlifidase can play a key role in allowing us to treat those kidney transplant patients with the highest need." Further details of the trial (EudraCT number 2021-002640-70) can be found on the EU Clinical Trials Register. 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.2 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.3,4 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.5,6 Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.7,8 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.1 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing authorization 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.1 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.1 Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).10 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.2 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,8-11 and in a long-term observational follow-up study.12 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one post-authorization safety and efficacy study, and a related long-term follow up study.13,14 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%.15 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.15 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 in the U.S. and Europe waiting for a new kidney.16 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. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a second-generation IgG cleaving molecule with redosing potential. 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. ©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. References European Medicines Agency. Idefirix® summary of product characteristics. Available at: . 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/ Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic Strategies. J Immunol Res. 2018 Mar 5;2018:5986740. Available at: Heidt S, et al. Highly Sensitized Patients are Well Serves by Receiving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: 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 [June 2024]. 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. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125 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. Long-term outcomes at 5 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2024 Dec 4:S1600-6135(24)00742-1. doi: 10.1016/j.ajt.2024.11.029. Epub ahead of print. PMID: 39643005 EU Clinical trial register, 20-HMedIdeS-19. Available at: 20-HMedIdeS-20. Available at: NIH (2018). What is kidney failure? Available at: Newsletter Transplant 2024. "International figures on donation and transplantation 2023". Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Last accessed: February 2025. This information was brought to you by Cision . The following files are available for download: SOURCE Hansa Biopharma AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 2Drug ApprovalImmunotherapy

100 Deals associated with Imlifidase

External Link

KEGG	Wiki	ATC	Drug Bank
D11470	Imlifidase	L04AA41	DB15258

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Renal transplant rejection	European Union	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Norway	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Liechtenstein	Hansa Biopharma AB	25 Aug 2020
Renal transplant rejection	Iceland	Hansa Biopharma AB	25 Aug 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	United Kingdom	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Netherlands	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Sweden	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Czechia	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Spain	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Ireland	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	United States	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Germany	Hansa Biopharma AB	22 Dec 2022
Rapidly Progressive Glomerulonephritis With Pulmonary Hemorrhage	Phase 3	Italy	Hansa Biopharma AB	22 Dec 2022
Renal transplant rejection	Phase 3	United States	Hansa Biopharma AB	14 Oct 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASGCT2025	Not Applicable	HIV Seropositivity	44	Imlifidase (Seropositive Individuals)	qlxzcqkhpt(ulxwtkqjpu) = pqzjmynlui goyxqcjpvr (yvvmwnsbmg )	Positive	13 May 2025
				Clinical Trial Subjects Treated with Imlifidase	qlxzcqkhpt(ulxwtkqjpu) = svexbfaetr goyxqcjpvr (yvvmwnsbmg )
NCT03943589 (15-HMedIdeS-09, CTgov)	Phase 2	Guillain-Barre Syndrome	30	Imlifidase	dhzauarrin(iaekdgufpo) = poxogggveu avghmfotuq (aitlmgtqga, dwusqotsul - xcejsxzzuw) View more	-	09 Apr 2025
NCT05049850 (CTgov)	Phase 2	Renal transplant rejection	3	Imlifidase	ixyszxckgt(cejvilmnfk) = iekddzdmjy rjgpthsjio (tpjoeprilv, cinbknhqca - jhqrxhfvex) View more	-	17 Mar 2025
NCT03943589 (15-HMedIdeS-09, PRNewswire) Manual	Phase 2	Guillain-Barre Syndrome	30	imlifidase	fdmazfsqes(xmngnwbhmt) = prdyxxxcvh rtorovylvo (kopgfncbxh ) View more	Positive	17 Dec 2024
NCT04711850 (EudraCT number: 2018-000022-66, 2020-004777-49, Pubmed \| Clin Transplant)	Not Applicable	Renal transplant rejection DSA	-	Imlifidase	ganpilcnhh(ttixwndpih) = wawqodsqsi yebrzsysze (akuzbfvtwb ) View more	Negative	01 Jul 2024
				Imlifidase (Plasmapheresis)	ganpilcnhh(ttixwndpih) = oodanltoyc yebrzsysze (akuzbfvtwb ) View more
NCT03897205 (16-HMedIdes-12, CTgov)	Phase 2	Renal transplant rejection	30	Imlifidase (Imlifidase)	rqoqexvyvd(xnzxioqvxm) = rywkqtxpdo xvauvhgtng (nevctipajz, wiwhhyaphr - jcwhlhcmxg) View more	-	28 Feb 2024
				Plasma Exchange (Plasma Exchange)	rqoqexvyvd(xnzxioqvxm) = obwuegfdjj xvauvhgtng (nevctipajz, nuslnnhmov - jfzncwkqty) View more
NCT03897205 (16-HMedIdes-12, PRNewswire) Manual	Phase 2	AMR Syndrome	30	imlifidase	jyqokunvyk(ediadnyzao) = gtwdvrnzge fvwsbjxexx (umpefkstpu ) View more	Positive	14 Dec 2023
				standard of care	jyqokunvyk(ediadnyzao) = zpzzpktrnc fvwsbjxexx (umpefkstpu ) View more
NCT03943589 (15-HMedIdeS-09, Biospace) Manual	Phase 2	Guillain-Barre Syndrome	-	imlifidase+ intravenous immunoglobulin	(yvqwbrnldz) = Imlifidase was safe and well tolerated srchcrsydj (zypdjakwtf ) View more	Positive	07 Dec 2023
NCT03897205 (Biospace) Manual	Phase 2	Graft Rejection	30	Imlifidase	(uduyvyqnjo) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study newkgmhota (dvaymlalcf )	Positive	28 Nov 2022
				plasma exchange
ESGCT2022	Not Applicable	-	-	Imlifidase	spuphnfjmu(itkgjaadgd) = khxunuevlr nlstndfggu (udbdnbttuy ) View more	-	11 Oct 2022

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

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis