Science and Technology

Hansa Biopharma Announces Presentation of Groundbreaking Imlifidase Data at ATC 2024

LUND, Sweden, May 21, 2024 -- Hansa Biopharma ("Hansa"), a trailblazing biopharmaceutical entity, has declared an exciting line-up of presentations covering imlifidase to occur during the prestigious American Transplant Congress (ATC). The ATC serves as a converging venue for experts from the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (ATS). Imlifidase, Hansa's signature antibody-cleaving enzyme, meticulously targets the IgG antibodies to curtail IgG-mediated immune responses.

Søren Tulstrup, the CEO and President of Hansa Biopharma, voices the company's anticipation of ATC as an excellent stage for unveiling vital scientific data and for spotlighting imlifidase's potential in expediting transplant possibilities for hypersensitized patients. The company's participation in the ATC underscores its unwavering dedication to pioneering novel approaches in the realm of transplant care, with the aim of bringing transformative treatments to the fore.

Currently, imlifidase holds a conditional marketing authorization in Europe under the commercial name IDEFIRIX®, designated for the desensitization treatment of hypersensitized adults in need of a kidney transplant from a deceased donor with whom they have a positive crossmatch. Hansa is actively engaging in a Phase 3 trial in the US, with the strategic plan to request approval for a Biologic License Application (BLA) from the US Food and Drug Administration (FDA) in 2025. Furthermore, its utility is also being explored in the context of pre-treatment for gene therapy in patients with rare diseases who harbor pre-existing antibodies, and also in several autoimmune disorders, such as anti-GBM and Guillain-Barre Syndrome (GBS).

At the core of the ATC meetings are key abstracts that embody the innovative strides Hansa Biopharma is taking:

Groundbreaking Research and Clinical Findings

• Restoration of COVID-Specific IgG Antibodies Post-Imlifidase Treatment: Discovering immunity regain post-therapy.

  • (Poster Hall, Exhibit Hall A, Level 2; Sunday, June 2, 9:15 am – 10:00 am EST)

• Probing a Phase II Study on DSA Reappearance in Hypersensitized Living Donor Kidney Recipients Post-Imlifidase Treatment: Unraveling the dynamics of antibody surge following treatment.

  • (107-AB, Level 1; Monday, June 3, 1:40 – 1:50 pm ET)

• Investigating Imlifidase in Hypersensitized Kidney Transplant Recipients with a Deceased Donor Positive Crossmatch: Insights from French Guideline-Conducted Transplantations:

  • (Abstract D092; Poster Hall, Exhibit Hall A, Level 2; Tuesday, June 4, 9:15 – 10:00 am ET)

• Examining Five Years of Imlifidase: Clinical Outcomes and DSA Analysis: An evaluation of long-term effectiveness and repercussions.

  • (118-ABC, Level 1; Tuesday, June 4, 10:15 – 10:25 am ET)

• Extended Surveillance of Imlifidase Desensitized Kidney Transplant Patients: A 5-Year Combined Analysis: Observing the sustained impact on recipients.

  • (108-AB, Level 1; Wednesday, June 5, 9:40 – 9:50 am ET)

For those requiring additional information, the following contacts are available: Stephanie Kenney, VP Global Corporate Affairs, at [email protected], and Evan Ballantyne, CFO, at [email protected]

Understanding the Highly Sensitized Patient Population

Highly sensitized patients, burdened by pre-formed antibodies known as donor-specific antibodies (DSAs) against human leukocyte antigens (HLAs), often face the dire risk of tissue damage and potential transplant rejections. The complex immunological profiles these patients possess result in prolonged periods on transplant waiting lists and a correlating increase in mortality risk. In Europe and the United States, approximately 10-15% of individuals on transplant waiting lists fall into this hypersensitized category.

Unraveling the Potential of IDEFIRIX® (imlifidase)

Originating from Streptococcus pyogenes, imlifidase is a revolutionary antibody-cleaving enzyme capable of selectively targeting and breaking down IgG antibodies, thus impeding the IgG-mediated immune responses. With a swiftly efficient mechanism, imlifidase commences its antibody-cleaving capabilities shortly after administration. In Europe, IDEFIRIX® is granted conditional marketing consent for desensitizing highly sensitized adult kidney transplant candidates facing positive crossmatches with available deceased donors. Its strategic use is prioritized for patients who otherwise have bleak chances of transplantation under existing kidney allocation systems, even after considering prioritization programs for hypersensitized individuals. Reviewed under the European Medicines Agency's PRIME program, IDEFIRIX® has been identified to potentially confer a significant therapeutic advantage or serve patients without alternative treatments.

This antibody-cleaving enzyme has emerged as an innovative strategy for the desensitization of transplant candidates, who have preformed anti-HLA donor-specific antibodies (DSAs); these antibodies, if left unchecked, can bind and damage the transplanted organ. By inactivating these, imlifidase opens a critical timeframe in which transplants can be carried out—just before the body begins producing new IgG antibodies, at which point post-transplant immunosuppression is in effect to help stave off organ rejection. The potent efficacy of imlifidase as a pre-transplant treatment to diminish IgG was examined across four phase 2 clinical trials. Hansa is determined to supply additional clinical evidence, including data from an observational follow-up study and a post-approval efficacy study.

Comprehensive product details can be obtained through the initial Summary of Product Characteristics available here.

The Burden of Kidney Failure

Progressing nephropathy culminating in kidney failure, or End-Stage Renal Disease (ESRD), manifests when a patient's renal function deteriorates to below 15%. The toll it takes on health is substantial, with close to 2.5 million individuals globally affected. Opting for a kidney transplant generally results in improved survival rates, enhances quality of life, and is more economical compared to prolonged dialysis treatments. In the European Union and the United Kingdom alone, an estimated 80,000 patients with kidney ailments are on the waiting list for a transplant.

Behind the Scenes: Hansa Biopharma's Journey

At the frontier of clinical-stage biopharmaceutical innovation, Hansa Biopharma is dedicated to developing and commercializing life-changing therapies for individuals grappling with rare immunological afflictions. Hansa's leading-edge IgG antibody-cleaving enzyme therapy has been pivotal in making kidney transplantation a reality for hypersensitized patients. With an extensive and burgeoning R&D platform grounded on proprietary IgG-cleaving enzyme technology, the company is earnestly addressing the critical medical needs in transplantation, autoimmune diseases, gene therapy, and cancer. Headquartered in Lund, Sweden, with activities spanning across Europe and the United States, Hansa Biopharma proudly trades on Nasdaq Stockholm under the ticker HNSA. Discover more about Hansa Biopharma at www.hansabiopharma.com and stay connected via LinkedIn.

The trademarks Hansa Biopharma, the beacon logo, and IDEFIRIX are the proprietary marks of Hansa Biopharma AB in Lund, Sweden.

References

An extensive compilation of references related to Hansa Biopharma's endeavors, highly sensitized patient populations, and IDEFIRIX® can be found at the following links:

1. Eurostam Report detailing strategies to enhance transplantation for highly sensitized patients, available at Eurostam Report.
2. Redfield's article on the plight of highly sensitized patients and their heightened mortality risk on waiting lists.
3. Lonze's exploration into transplantation challenges for patients with pre-formed antibodies.
4. Edqm and SRTR Database pages, analyzing donation and transplantation international figures and allocation systems.
5. European Medicines Agency's summary of product characteristics for IDEFIRIX®, located at European Medicines Agency IDEFIRIX®.
6. European Medicines Agency's PRIority Medicines (PRIME) program which includes IDEFIRIX®.
7. Jordan SC's contributions gauging the medical potential of imlifidase.
8. Manook's insights into the preformed antibodies in kidney transplantation.
9. Winstedt's evaluation of imlifidase's impact.
10. Lorant and Jordan's discussions on antibody reduction pre-transplantation.
11. The National Institutes of Health's (NIH) assessment of kidney failure, available at NIH Kidney Failure.
12. Newsletter Transplant's global kidney disease statistics, found at Newsletter Transplant.

This pivotal information has been shared courtesy of Cision at http://news.cision.com.

Further details regarding the announcement and downloadable files can be accessed through the following link: Hansa Biopharma at ATC 2024.

Download the PDF titled 240521_HansaBiopharmaAtATC2024_en at Download PDF.

SOURCE: Hansa Biopharma AB