(AGENPARL) – mar 21 maggio 2024 Lund, Sweden, 21 May, 2024. Hansa Biopharma, “Hansa” (Nasdaq 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:
Abstract Title and Location Presentation Details
Reestablishment of COVID-Specific IgG Poster Presentation
Antibodies After Imlifidase Treatment Sunday 2 June
Abstract B058 9:15 am – 10:00 am EST
Poster Hall’ Exhibit Hall A’ Level 2
A Phase II Study Investigating DSA Late Breaking Abstracts:
Rebound in Highly Sensitized Living Clinical Rapid Fire Oral
Donor Kidney Transplant Recipients Abstract
Treated with Imlifidase Monday 3 June
107-AB’ Level 1 1:40 – 1:50 pm ET
Imlifidase for Highly Poster Presentation
Sensitized Kidney Transplant Tuesday 4 June
Recipients with 9:15 – 10:00 am ET
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
Five Years Rapid Fire Oral Abstract
of Imlifidase: Clinical Outcomes and Tuesday 4 June
Donor-Specific Antibodies 10:15 – 10:25 am ET
118-ABC’ Level 1
Long-Term Follow Up of Imlifidase Rapid Fire Oral Abstract
Desensitized Kidney Transplant Wednesday 5 June
Recipients: 5 Year Pooled Analysis 9:40 – 9:50 am ET
108-AB’ Level 1
— ENDS —
Contacts for more information
Stephanie Kenney, VP Global Corporate Affairs
Evan Ballantyne, CFO
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 (https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf).
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 http://www.hansabiopharma.com
and follow us on LinkedIn (https://www.linkedin.com/company/hansa-medical-ab/).
©2024 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are
trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.
References
1. 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.
2. Redfield R, et al. Nephrol Dial Transplant 2016; 31:1746-1753
3. Lonze BE, et al. Ann Surg 2018; 268(3):488-496
4. EDQM. (2020). International figures on donation and Transplantation 2019
5. 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.
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.
7. Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
8. Manook M, et al. Lancet 2017; 389(10070):727-734.
9. Winstedt L, et al. PLoS One 2015; 10(7): e013201
10. Lorant T, et al. Am J Transplant 2018;18(11):2752-2762.
11. Jordan SC, et al. Transplantation October 21 2020 – volume online first
issue
12. NIH (2018). What is kidney failure? Available at:
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what
-is-kidney-failure.
13. Newsletter Transplant. Available at: https://freepub.edqm.eu/publications.
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Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
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Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
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