TAIPEI, February 22, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced the positive results of their phase 2b clinical trial for the prevention of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) at the 2024 Tandem Meeting of ASTCT and CIBMTR.

aGVHD, primarily mediated by effector T-lymphocytes, is a major cause of morbidity and mortality after alloHCT. RG1-2001 contains the active moiety α-GalCer, which binds the CD1d receptor of antigen-presenting cells resulting in activation of iNK T cells, resulting in a cytokine-dependent Treg proliferation. This phase 2b trial is an open-label, multi-center, single-arm study. RGI-2001, added to standard immunosuppression, is being evaluated for the potential to reduce the incidence or severity of aGVHD in patients following alloHCT. The results are compared with a contemporaneous CIBMTR cohort (NCT04014790).

Through day 100, the incidence of grades II-IV aGVHD was 22.9% of subjects on RGI-2001 compared to 38.8% of those in the CIBMTR cohort. RGI-2001 also demonstrates higher rates of acute GVHD-free survival (72.9% in grade II-IV and 91.7% in grades III-IV compared with 50.7% and 77.3% in those on CIBMTR cohort, respectively) and overall survival (91.7% compared with 79.2% on CIBMTR cohort). Relapse rates between the 2 cohorts are similar, suggesting no compromise of the graft-versus-leukemia effect.

“We are thrilled to be selected for oral presentation at the Tandem Meeting. The results showed promising safety and efficacy outcomes using RGI-2001 in addition to the standard GVHD prevention medications, providing a strong foundation to advance our plans for phase 3 study.” said Kenzo Kosuda, CEO of REGiMMUNE.

REGiMMUNE concludes that RGI-2001 added to standard-of-care shows positive results for acute GVHD prevention with survival benefit and no increase in relapse compared to CIBMTR control. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT.

Details of presentation, please see RGI-2001 Tandem 2024 Oral Presentation

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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

 

 

2024年度Tandem學會：REGiMMUNE的RGI-2001臨床2b期研究展示出較高的無aGVHD存活且無增加血癌復發

2024年2月22日，台北 – 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，今天在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)聯合舉辦的Tandem學會上宣布RGI-2001臨床2b期試驗結果，該試驗旨在預防異體造血幹細胞移植 (alloHCT)後急性移植物抗宿主病 (aGVHD)。

aGVHD主要由作用型T淋巴細胞引發，是alloHCT後造成手術病患併發症和死亡的主要原因，RG1-2001含有活性成分a-GalCer，該成分結合抗原呈現細胞的CD1d受體，進而活化iNKT細胞，促使Treg細胞增殖。本次發表的臨床2b期試驗是一項開放、多中心、單臂研究，RGI-2001與標準療法的免疫抑制劑合併使用，評估其在alloHCT術後患者中降低aGVHD發病率或嚴重程度的潛力 (NCT04014790)，試驗結果將與使用標準療法的病患進行比較，該數據由CIBMTR提供。

接受RGI-2001治療後的第100天，受試者II-IV級aGVHD的發生率為22.9%，而在CIBMTR群體中為38.8%。試驗結果顯示RGI-2001有較高的無aGVHD存活率 (II-IV級為72.9%，III-IV級為91.7%，而在CIBMTR群體中分別為50.7%和77.3%)，以及整體存活率 (為91.7%，而在CIBMTR群體中為79.2%)。兩個群體之間的原疾病復發率相似，表明使用RGI-2001沒有影響移植物對抗血癌 (graft versus leukemia, GVL)作用。

REGiMMUNE的CEO小須田建三表示：「我們很高興被選為Tandem會議的口頭報告人，結果顯示使用RGI-2001與GVHD預防的標準療法藥物相比，取得了安全性和有效性結果，為我們推進臨床3期研究計劃奠定了堅實的基礎。」

總體來說，標準療法藥物併用RGI-2001顯示出對aGVHD的預防效果良好，並且與CIBMTR對照組相比，具有較好之生存臨床益處且不增加復發。REGiMMUNE基於這些結果，計劃進行臨床3期隨機對照研究，以確認RGI-2001在alloHCT後的有效性和安全性。

更多相關資訊，請參考簡報檔 RGI-2001 Tandem 2024 Oral Presentation

本文結束

 

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