TAIPEI, April 11, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announces the poster presentation at the American Association of Cancer Research (AACR) Annual Meeting. The poster presentation is to highlight RGI-2001 phase 2b result, including the latest correlative analyses of changes in regulatory T (Treg) and natural killer T (NKT) cell populations to assess the cellular kinetics of RGI-2001 in the prevention of acute Graft versus host disease.
Based on literature, higher numbers of NKT cells are associated with a reduced risk of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) (Rubio et al. 2017; Rubio et al. 2012). Patients with rapid NKT cell expansion exhibit a lower risk of GVHD and improved survival (Chaidos et al. 2012; Malard et al. 2016).
Flow cytometry studies indicate peripheral NKT expansion at Day 28 in patients receiving clinical benefit from RGI- 2001.The mean levels of absolute Tregs at Day 42, 1 week following the last dose of RGI-2001, were higher in subjects who were alive and had not developed Grade II-IV aGVHD by Day 180 compared with those who had died and/or did develop aGVHD. A large percentage of activated Tregs were proliferating, with activated Tregs proliferating to a greater extent compared with nonactivated Tregs. The proliferation was greater in after- treatment compared to baseline samples. This effect was also observed in the single-dose study (Phase 1/2a RGI-2001-002). The results from exploratory correlative analyses are consistent with the proposed mechanism of action of RGI-2001. RGI-2001 may induce activation and proliferation of NKT cells, leading to a reduction in aGVHD through increasing the proliferation of activated Tregs.
“Our data suggest that RGI-2001 prevents acute GVHD through NKT and Treg cells without compromising general immune function and has the potential to become a best-in-class drug for preventing acute GVHD,” said Kenzo Kosuda, CEO of REGiMMUNE. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT.
Dr Jack Bui,MD,Ph.D. from University of California, San Diego, is the presenter for this important poster for RGI-2001. Details of presentation, please see RGI-2001 AACR Poster Presentation.
Title: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood.
Authors: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3;
Session Title: PO.CT02.02 – Phase II Clinical Trials 2
Session Date and Time: April 8th 2024, 1:30 PM – 5:00 PM
1 UC San Diego, La Jolla, CA
2 REGIMMUNE, CA
3 Massachusetts General Hospital, Boston, MA
Ends
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
REGiMMUNE於AACR 2024年會發表RGI-2001臨床2b期試驗的最新分析數據
2024年4月11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，今天宣布在美國癌症研究協會 (American Association for Cancer Research, AACR) 年度會議上進行了海報發表。這次發表旨在進一步分析RGI-2001第2b期試驗的結果，包括最新的相關分析，評估RGI-2001在預防急性移植物抗宿主病 (acute graft-versus-host disease, aGVHD) 中的細胞動力學，包括調節性T (regulatory T, Treg) 細胞和自然殺手T (natural killer T, NKT) 細胞數量的變化。
根據文獻，NKT細胞數量較高的患者在異體造血幹細胞移植 (allogeneic hematopoietic cell transplantation, alloHCT) 後急性移植物抗宿主病的風險降低 (Rubio et al. 2017; Rubio et al. 2012) ，NKT細胞擴增速度較快的患者發生GVHD的風險較低並且有較佳的生存率 (Chaidos et al. 2012; Malard et al. 2016)。
RGI-2001臨床2b期試驗的流式細胞儀分析數據表明，接受RGI-2001治療且後續無發生aGVHD的受試者中，第28天出現外周NKT細胞擴增，第42天，也就是完成RGI-2001最後一劑給藥後一週，Treg細胞數的平均水平較已死亡和/或發展aGVHD的受試者之Treg細胞數高。RGI-2001用藥後，大部分活化Treg細胞在進行增殖，與未活化Treg細胞相比的增殖幅度更大。與基線樣本相比，RGI-2001治療後Treg細胞的增殖程度更大，這一效果也在臨床1/2a期的單劑量研究中觀察到。相關分析的結果與RGI-2001的作用機制一致，RGI-2001可能通過誘導NKT細胞的活化和增殖，進而增加活化Tregs的增殖來降低aGVHD風險，。
REGiMMUNE的執行長小須田建三先生表示：「我們的數據表明，RGI-2001通過NKT和Treg細胞預防急性GVHD，並且不會降低一般免疫功能，有望成為預防急性GVHD的同類最佳 (best-in-class) 藥物。」根據這些結果，REGiMMUNE規劃進行臨床3期隨機對照研究，以確認RGI-2001在alloHCT中的有效性和安全性。
加州大學聖地牙哥分校的Jack Bui博士是此次關於RGI-2001臨床試驗結果海報的主講人，海報詳情請參閱RGI-2001 AACR Poster Presentation。
標題: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood.
作者: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3;
會議標題: PO.CT02.02 – Phase II Clinical Trials 2
發表日期及時間: April 8th 2024, 1:30 PM – 5:00 PM
1 UC San Diego, La Jolla, CA
2 REGIMMUNE, CA
3 Massachusetts General Hospital, Boston, MA
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