share_log

Hansa Biopharma to Present Data at 2024 American Transplant Congress Annual Meeting

Hansa Biopharma to Present Data at 2024 American Transplant Congress Annual Meeting

漢莎生物製藥將在2024年美國移植大會年會上公佈數據
PR Newswire ·  05/21 13:18

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

瑞典隆德,2024年5月21日 /PRNewswire/--。漢莎生物製藥公司 “漢莎”(納斯達克股票代碼:HNSA)(斯德哥爾摩股票代碼:HNSA)今天宣佈,有關imlifidase的數據將在美國移植大會(ATC)、美國移植外科學會(ASTS)和美國移植學會(ATS)的聯合年會上公佈。Imlifidase 是 Hansa 獨特的抗體裂解酶,可特異性靶向 IgG 並抑制 IgG 介導的免疫反應。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."

漢莎生物製藥首席執行官兼總裁索倫·塔爾斯特魯普表示:“ATC是漢莎分享有關imlifidase及其在促進高度敏感患者移植方面的作用的最新科學和數據的寶貴機會。我們很高興參加ATC,展示我們在移植治療領域取得的進展,這些數據凸顯了我們對推進創新的移植護理新方法的持續承諾。”

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).

Imlifidase以IDEFIRIX的商品名在歐洲獲得了有條件的上市許可 用於對高度敏感的成年腎移植患者進行脫敏治療,與現有已故捐贈者的交叉配型呈陽性。該公司正在美國進行一項開放標籤、隨機對照的腎臟移植3期試驗,並計劃於2025年向美國食品藥品監督管理局(FDA)提交生物許可申請(BLA)。該分子還被研究爲已有抗體的罕見病患者以及包括抗GBM和吉蘭巴利綜合症(GBS)在內的自身免疫性疾病的基因治療的預處理。

Key abstracts at ATC include:

ATC 的主要摘要包括:

Abstract Title and Location

Presentation Details

Reestablishment of COVID-Specific IgG Antibodies After Imlifidase Treatment
Abstract B058
Poster Hall‚ Exhibit Hall A‚ Level 2

Poster Presentation
Sunday 2 June
9:15 am – 10:00 am EST

A Phase II Study Investigating DSA Rebound in Highly Sensitized Living Donor Kidney Transplant Recipients Treated with Imlifidase
107-AB‚ Level 1

Late Breaking Abstracts: Clinical Rapid Fire Oral Abstract
Monday 3 June
1:40 – 1:50 pm ET

Imlifidase for Highly Sensitized Kidney Transplant Recipients with 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

Poster Presentation
Tuesday 4 June
9:15 – 10:00 am ET

Five Years of Imlifidase: Clinical Outcomes and Donor-Specific Antibodies
118-ABC‚ Level 1

Rapid Fire Oral Abstract
Tuesday 4 June
10:15 – 10:25 am ET

Long-Term Follow Up of Imlifidase Desensitized Kidney Transplant Recipients: 5 Year Pooled Analysis
108-AB‚ Level 1

Rapid Fire Oral Abstract
Wednesday 5 June
9:40 – 9:50 am ET

摘要標題和位置

演示詳情

Imlifidase 治療後重建 COVID 特異性 IgG 抗體
摘要 B058
海報大廳 A展廳 2層

海報演示
6 月 2 日星期日
美國東部時間上午 9:15 — 上午 10:00

一項II期研究調查了接受Imlifidase治療的高敏感活體腎臟移植受者的DSA反彈
107-AB,1 級

最新摘要:臨床快速射擊口頭摘要
6 月 3 日星期一
美國東部時間下午 1:40 — 1:50

Imlifidase 適用於與已故捐贈者交叉匹配陽性的高度敏感腎臟移植受者:根據法國指南進行的腎臟移植結果
摘要 D092
海報大廳 A展廳 2層

海報演示
6月4日星期二
美國東部時間上午 9:15 — 10:00

Imlifidase 的五年:臨床結果和捐贈者特異性抗體
118-ABC,1 級

速射口頭摘要
6月4日星期二
美國東部時間上午 10:15 — 10:25

Imlifidase 脫敏腎移植受者的長期隨訪:5 年合併分析
108-AB,等級 1

速射口頭摘要
6月5日星期三
美國東部時間上午 9:40 — 9:50

Contacts for more information
Stephanie Kenney, VP Global Corporate Affairs
E: [email protected]

Evan Ballantyne, CFO
E: [email protected]

聯繫方式獲取更多信息
斯蒂芬妮·肯尼, 全球企業事務副總裁
E: [電子郵件保護]

首席財務官埃文·巴蘭坦
E: [電子郵件保護]

Notes to editors

編輯注意事項

About highly sensitized patients

關於高度敏感的患者

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

高度敏感的患者預先形成了稱爲供體特異性抗體(DSA)的抗體,對人類白細胞抗原(HLA)具有廣泛的反應性,這可能導致組織損傷和可能的移植排斥反應。1 DSA的存在意味着高度敏感的患者接受移植的機會往往有限或根本沒有,因爲尋找相容的供體器官可能特別具有挑戰性。2,3 他們的免疫學特徵的複雜性意味着高度敏感的患者在移植等待名單上的時間比平均水平長,有證據表明,等待合適捐贈者的時間較長會增加死亡風險。2,3 在美國和歐洲,高度敏感的患者約佔移植候補名單上患者總數的10-15%。4,5

About IDEFIRIX (imlifidase)

關於 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 是一種源自化膿性鏈球菌的抗體裂解酶,可特異性靶向和裂解免疫球蛋白 G (IgG) 抗體,抑制 IgG 介導的免疫反應。6 它起效迅速,可在給藥後數小時內分解 IgG 抗體並抑制其活性。

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在歐洲獲得了有條件的上市許可,並以IDEFIRIX的商品名上市,用於對與現有已故捐贈者交叉配對呈陽性的高度敏感的成年腎移植患者的脫敏治療。IDEFIRIX的使用應僅限在現有腎臟分配系統下不太可能進行移植的患者,包括針對高度敏感患者的優先計劃。6 作爲歐洲藥品管理局(EMA)優先藥物(PRIME)計劃的一部分,對IDEFIRIX進行了審查,該計劃支持可能比現有療法具有重大治療優勢或使沒有治療選擇的患者受益的藥物。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.

Imlifidase是一種前景看好的新策略,用於對捐贈者特異性抗HLA(人類白細胞抗原)抗體(DSA)進行移植患者脫敏。7 高度敏感的患者的這些預製抗體含量很高,可以與供體器官結合並損害移植。8 一旦使用imlifidase將其滅活,就有機會進行移植。當人體開始合成新的IgG時,患者將接受移植後的免疫抑制治療,以降低器官排斥的風險。

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.

四項爲期六個月的2期開放標籤、單臂臨床試驗研究了imlifidase作爲減少捐贈者特異性IgG的移植前治療的療效和安全性。7,9-11 漢莎正在收集更多臨床證據,並將根據一項觀察性隨訪研究和一項批准後療效研究提交額外的療效和安全性數據。

Full product information can be accessed via the initial Summary of Product Characteristics found here.

完整的產品信息可通過此處的初始產品特性摘要獲取。

About kidney failure

關於腎功能衰竭

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

當患者的腎功能低於 15% 時,腎臟疾病可以發展爲腎衰竭或終末期腎臟疾病(ESRD)。12 ESRD構成了巨大的健康負擔,影響了全球近250萬名患者。12 腎臟移植是合適的ESRD患者的首選治療方法,因爲與長期透析相比,腎臟移植可以提高存活率和生活質量,並且可以節省成本。在歐盟和英國,大約有80,000名腎臟患者在移植候補名單上。13

About Hansa Biopharma

關於漢莎生物製藥

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.

Hansa Biopharma是一家處於商業階段的開創性生物製藥公司,其使命是爲患有罕見免疫疾病的患者開發和商業化創新、挽救生命和改變生命的療法。漢莎生物製藥開發了同類首創的免疫球蛋白G(IgG)抗體裂解酶療法,該療法已被證明可以對高度敏感的患者進行腎臟移植。漢莎生物製藥基於公司專有的IgG-cleaving 酶技術平台,擁有豐富且不斷擴大的研發計劃,旨在解決移植、自身免疫性疾病、基因療法和癌症方面嚴重未得到滿足的醫療需求。漢莎生物製藥總部位於瑞典隆德,在歐洲和美國開展業務。該公司在斯德哥爾摩納斯達克上市,股票代碼爲HNSA。要了解更多信息,請在領英上關注我們。

2024 Hansa Biopharma. Hansa Biopharma, the beacon logo, and IDEFIRIX are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

2024 漢莎生物製藥。漢莎生物製藥、信標徽標和IDEFIRIX是瑞典隆德漢莎生物製藥公司的商標。版權所有。

References

參考文獻

  1. Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at
  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:
  6. European Medicines Agency. Idefirix summary of product characteristics. Available at:
  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:
  13. Newsletter Transplant. Available at:
  1. Eurostam報告(一項在可接受的HLA不匹配的基礎上加強對高度敏感患者的移植的全歐洲戰略。)可在以下位置獲得
  2. 雷德菲爾德 R 等人2016 年 Nephrol 撥號移植;31:1746 —1753
  3. Lonze BE 等Ann Surg 2018; 268 (3): 488—496
  4. EDQM。(2020)。2019年國際捐贈和移植數據
  5. SRTR 數據庫和分配系統的個人評估 6_歐洲藥品管理局。Idefirix 產品特性摘要。可在以下網址獲得:
  6. 歐洲藥品管理局。Idefirix 產品特性摘要。可在以下網址獲得:
  7. 喬丹 SC 等2017 年 N Engl J Med; 377 (5): 442-453。
  8. Manook M 等人《柳葉刀》2017; 389 (10070): 727-734。
  9. Winstedt L 等人PLoS One 2015;10 (7):e013201
  10. Lorant T 等人Am J Transplant 2018;18 (11): 2752-2762。
  11. 喬丹 SC 等移植 2020 年 10 月 21 日——在線卷第一期
  12. 美國國立衛生研究院 (2018)。什麼是腎衰竭?可在以下網址獲得:
  13. 時事通訊移植。可在以下網址獲得:

This information was brought to you by Cision

這些信息是由 Cision 帶給你的

The following files are available for download:

以下文件可供下載:

240521_HansaBiopharmaAtATC2024_en

240521_Hansabiopharmaatc2024_EN

SOURCE Hansa Biopharma AB

來源 Hansa Biopharma AB

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論