TAIPEI, December 28, 2023 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced that the Phase 2b clinical data from 48 patients receiving RGI-2001 for the prevention of acute graft-versus-host disease (aGVHD) will be presented at the 2024 Tandem Meeting in San Antonio, Texas on February 22, 2024. The Tandem Meetings is the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), with research and educational sessions for investigators, clinicians, laboratory technicians, clinical research professionals, nurses, pharmacists, administrators and allied health professionals.

This is a Phase 2 study, evaluating the safety and efficacy of RGI-2001 for the prevention of aGVHD in subjects following allogeneic hematopoietic stem cell transplantation (HSCT). This study tests the hypothesis that RGI-2001 prevents GVHD by expanding regulatory T cells soon after allogeneic HSCT. The incidence and severity of aGVHD was evaluated in patients treated with RGI-2001 in addition to standard GVHD prevention medications. “Based on the analysis, RGI-2001 showed reduced incidence of aGVHD with an excellent safety profile. I am thrilled that the RGI-2001 study results have been selected for oral presentation at the Tandem meeting. We look forward to sharing future findings as we work to deliver breakthrough immune medicines by harnessing the power of regulatory T cells,” said Kenzo Kosuda, CEO of REGiMMUNE Limited.

  • Session Name: S-OA-E – Oral Abstract – Session E – GVHD – I
  • Session Date and Time: Thursday, February 22, 2024, 3:15 PM – 4:45 PM CST
  • Presentation time: 4:30 PM CST
  • Location: Henry B. Gonzalez Convention Center – Stars at Night B1 (Ballroom Level)
  • Presenter: Yi-Bin Chen, MD
  • Title: RGI-2001 with CNI-Based Prophylaxis Demonstrates Better Acute Gvhd-Free Survival Following Myeloablative Allohct without Increased Relapse: Comparison of a Multi-Center Phase 2b Study with a Contemporaneous CIBMTR Cohort

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About RGI-2001

RGI-2001 is a liposomal injection formulation of an alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer binds to the CD1d receptor of antigen-presenting cells resulting in activation of invariant natural killer (iNKT) cells, resulting in the activation and expansion of regulatory T cells (Tregs), thus establishing immune tolerance. RGI-2001 is REGiMMUNE’s lead drug candidate, currently in Phase 3 planning for the prophylaxis of acute graft-versus-host disease (aGVHD).

About REGiMMUNE Limited

REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies by harnessing the power of regulatory T cells (Tregs). REGiMMUNE is creating a pipeline of novel product candidates that either enhance Treg activities for immune diseases or suppress Treg activities for cancer.

Corporate Contact

Miranda Yu
Investor Relations Manager
REGiMMUNE Corporation Ltd.
+886 2 2555 3377 #511
miranday@regimmune.com

 

瑞格RGI-2001臨床2b期數據結果通過Tandem審核將發表口頭報告

2023年12月28日，台北 – 今(28)日，瑞格國際生技，一家致力於開發免疫性疾病和癌症新型療法的臨床階段生技公司，宣布將於2024年2月22日在美國德州聖安東尼奧舉行的2024年Tandem學會上發布48名接受RGI-2001用於預防急性移植物抗宿主疾病 (aGVHD)的臨床2b期數據。Tandem學會是美國移植與細胞療法學會 (ASTCT)和國際血液與骨髓移植研究中心 (CIBMTR)的年度聯合會議，為研究人員、臨床醫師、實驗技術人員、臨床研究人員、護理師、藥劑師、行政人員和衛生人員提供教育課程。

RGI-2001臨床2b期試驗是一項2階段研究，評估RGI-2001在異體造血幹細胞移植 (HSCT)術後患者中預防aGVHD的安全性及有效性，該研究目的為檢驗RGI-2001透過HSCT術後迅速擴增調節型T細胞 (Tregs)來預防GVHD的假設，在接受RGI-2001治療合併標準療法的患者中，評估aGVHD的發生率和嚴重程度。REGiMMUNE執行長小須田建三表示：「根據分析數據，RGI-2001顯示出較低的aGVHD發生率且安全性極佳，我們很榮幸在Tandem會議中被選為口頭發表。我們期待透過Tregs來開發更多具突破性的免疫疾病藥物」。

  • 會議名稱：S-OA-E – Oral Abstract – Session E – GVHD – I
  • 會議日期及時間：2024年2月22日下午3:15 – 4:45 (CST)
  • 報告時間：下午4:40 (CST)
  • 地點：Henry B. Gonzalez Convention Center – Stars at Night B1 (Ballroom Level)
  • 講者：Yi-Bin Chen, MD
  • 標題：RGI-2001 with CNI-Based Prophylaxis Demonstrates Better Acute Gvhd-Free Survival Following Myeloablative Allohct without Increased Relapse: Comparison of a Multi-Center Phase 2b Study with a Contemporaneous CIBMTR Cohort

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關於RGI-2001

RGI-2001係為α-半乳糖神經醯胺(α-Galactosylceramide, α-GalCer)之微脂體注射製劑，α-GalCer與抗原呈遞細胞(Antigen Presenting Cells)上之CD1d配體結合，透過活化恆定自然殺手T細胞(iNKT)，近一步活化並擴增調節性T細胞，建立免疫耐受性。RGI-2001為瑞格國際生技主要之候選藥物，聚焦急性移植物抗宿主疾病(aGvHD)之預防，將於2024年開展美國之臨床3期試驗。

關於瑞格國際生技

瑞格係為專注於自體免疫疾病與癌症，運用調控調節性T細胞(Tregs)，開發創新免疫療法之臨床生技公司。瑞格構建之全新候選藥物組合係藉由調控調節性T細胞活性，用於治療免疫疾病及癌症。

媒體聯絡人

余明穎 (Miranda Yu)
投資人關係經理
瑞格國際生技股份有限公司
+886 2 2555 3377 #511
miranday@regimmune.com