A study for the safety of NKT cell therapy using alpha-galactosylceramide-pulesed dendritic cells for malignant tumors - NKT cell therapy using alphaGC-DCs for malignant tumors

开始日期2022-10-14

申办/合作机构

MEDINET Co., Ltd.

NCT04473911

/ Active, not recruiting临床1期IIT

Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation.
GVHD is a condition in which cells from the donor's tissue attack the organs.
RGI-2001 is an investigational treatment

开始日期2020-08-14

申办/合作机构

REGiMMUNE Corp.

NCT04014790

/ Completed临床2期

An Open Label Phase 2, Study to Evaluate the Safety and Efficacy of RGI-2001 for the Prevention of Acute Graft-vs-Host Disease Compared to Contemporary Controls in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

开始日期2019-11-25

申办/合作机构

REGiMMUNE Corp.

100 项与 KRN-7000 liposomal 相关的临床结果

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100 项与 KRN-7000 liposomal 相关的转化医学

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100 项与 KRN-7000 liposomal 相关的专利（医药）

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407

项与 KRN-7000 liposomal 相关的文献（医药）

2025-06-01·CARBOHYDRATE RESEARCH

Design, synthesis, and biological evaluation of novel KRN7000 analogues using 5α-gem-difluorocarba-β-l-arabinopyranose

Article

作者: Du, Yuguo ; Liu, Yuanfang ; Liu, Jun ; Zhao, Chuanfang

Two novel KRN7000 analogues, where d-galactopyranosyl residue was replaced by 5α-gem-difluorocarba-β-l-arabinopyranose, were designed based on docking computation and energy decomposition analyses. The target compounds were synthesized employing the key steps of Ferrier's carbocyclic ring closure and gem-difluoride formation with d-galactose as starting material. The in vivo bioassay revealed that the designed glycolipids could stimulate iNKT cells to produce cytokines IFN-γ and IL-4. The introduced hydroxyl groups on glycolipid acyl chain provided extra CD1d substrate affinities, and thus favored to boost Th1-type cytokine secretion. When the ring oxygen was replaced by CF₂ group on sugar unit, its TCR affinities were enhanced in contrast with KRN7000. The in vivo cytokine profiles induced by synthetic glycolipids were initially dominated by the binding ability of CD1/glycolipid, and then adjusted by affinity toward TCR in CD1/α-GalCer/TCR triplex structure. The current results could be helpful in designing of more efficient α-GalCer analogs.

2025-04-01·Journal for ImmunoTherapy of Cancer

Immunopeptidomics identified antigens for mRNA-lipid nanoparticle vaccines with alpha-galactosylceramide in multiple myeloma therapy

Article

作者: Vanderkerken, Karin ; De Veirman, Kim ; Meulewaeter, Sofie ; Thery, Fabien ; Verbeke, Rein ; De Bruyne, Elke ; Mwangi, Kevin ; Breckpot, Karine ; Lentacker, Ine ; De Beck, Lien ; Franceschini, Lorenzo ; Janssens, Edith ; Impens, Francis ; Menu, Eline ; Tu, Chenggong ; Van der Vreken, Arne

Background:

Invariant natural killer T (iNKT) cells and CD8+T cells are key in the immune response against multiple myeloma (MM), a largely incurable blood cancer. Immunization is a promising strategy to activate these T cell populations. To our knowledge, immunization with messenger RNA (mRNA) and the iNKT agonist, α-galactosylceramide (αGC), has not been studied in MM, as knowledge on clinically relevant antigens in preclinical MM models is lacking.

Methods:

Microarray data and immunopeptidomics (imPep) were used to identify candidate antigens for immunization in 5TMM models. Galsomes, lipid nanoparticles containing antigen mRNA and αGC were used to immunize 5T33MM-bearing mice. This treatment was combined with a CD40 agonist. Tumor burden and activation of iNKT cells and CD8+T cells were studied using M-protein electrophoresis, flow cytometry and ELISA.

Results:

RNA transcripts revealed survivin as a candidate antigen. Prime-boost Galsomes therapy targeting survivin significantly reduced M-protein levels despite low survivin-specific T cell responses. Further analysis showed potential T cell fratricide. ImPep revealed HSP60, Idiotype, PICALM and EF1A1 as candidate antigens. Prime-boost therapy with Galsomes targeting these antigens reduced MM growth significantly when combined with a CD40 agonist, coinciding with significantly improved antigen presentation, costimulation and cytotoxicity of iNKT cells and CD8+T cells.

Conclusion:

These findings highlight the potential of Galsomes, an mRNA vaccine designed to activate CD8+T cells and iNKT cells, for MM therapy, and emphasize the importance of combinatorial approaches, addressing immune anergy for effective MM immunotherapies.

2025-03-01·JOURNAL OF ANTIBIOTICS

KRN7000 analogues as biofilm disrupting agents against Streptococcus pyogenes and Proteus mirabilis

Article

作者: Sugathan, Shiburaj ; Remya Babu, R ; Krishnakumar, K A ; Lankalapalli, Ravi S

In this study, three KRN7000 analogues with variations in the sugar and glycosidic linkage were synthesised to assess their efficacy in disrupting the biofilms of S. pyogenes and P. mirabilis. All three analogues exhibited antibacterial activity, with the effects being more prominent at lower concentrations in S. pyogenes. The N-alkylated, 1-deoxy analogue emerged as the most effective, significantly reducing biofilm formation and extracellular polymeric substances (EPS) in both organisms. Microscopic analysis revealed notable disruption of biofilm structure by the analogue, resulting in a significant reduction in EPS for both organisms and decreasing cell surface hydrophobicity. These results position the KRN7000 analogue as a promising candidate for developing glycolipid-based antibiofilm agents.

项与 KRN-7000 liposomal 相关的新闻（医药）

2025-01-14

·药时空

化学顶刊发文！迈科康生物佐剂团队合作发表新型佐剂系统应用于肿瘤疫苗

近日，成都迈科康生物科技有限公司（以下简称“迈科康生物”）研发的基于新型复合佐剂应用于肿瘤免疫的合作研究论文《Enhanced Antitumor Immunity of a Globo H-Based Vaccine Enabled by the Combination Adjuvants of 3D-MPL and QS-21》，在国际知名期刊《Angewandte Chemie International Edition》（影响因子16.1）在线发表，迈科康生物全资子公司上海安奕康生物科技有限公司与中国科学院上海药物研究所、海南大学为文章的共同通讯单位。（全文链接：https://onlinelibrary.wiley.com/doi/10.1002/anie.202418948）关于新型佐剂相较于传统铝佐剂，新型佐剂可以显著提升免疫效能，以增强疫苗的保护效果。近年来，佐剂在肿瘤免疫中也得到广泛的应用，成为了疫苗研发的核心要素之一。为推动佐剂的深入研发，需要开发高效、规模化的制备方法，获得高质量、多样化的佐剂分子，从而促进新型疫苗的开发。关于新型佐剂系统的应用迈科康生物合作开发的新型佐剂系统可增强Globo H糖疫苗的抗肿瘤免疫，为相应治疗性疫苗的开发打下了坚实基础。Globo H是一种在多种恶性肿瘤中过度表达的糖类抗原，具有作为治疗性肿瘤疫苗靶点的潜力。尽管已有多种基于Globo H的肿瘤免疫设计，如何高效合成Globo H六糖抗原并与佐剂结合以增强免疫反应，仍是挑战。本研究发展了一种有效的化学-酶促合成方法，结合化学合成与酶促糖苷化，获得高纯度的Globo H六糖抗原，并高效结合载体蛋白，具有更高的立体构建效率和大规模生产潜力。除了抗原合成创新，研究还深入研究了相关佐剂的制备、选择及组合。除了本研究展示的3D-MPL、QS21、KRN7000佐剂之外，迈科康生物已自主开发了超过20种佐剂原材料，打造了3类成熟的传送系统，开发了10多种复合配方，形成了从佐剂原材料研发、生产到佐剂配方开发与应用的垂直化产业链，并基于公司创新佐剂平台开发出一系列预防性疫苗和肿瘤治疗疫苗。迈科康生物将持续推进新型佐剂的自主研发，解决佐剂来源性问题，开发更安全、高效的佐剂系统，推进临床应用与发展。 MAXVAX 关于迈科康生物迈科康生物成立于2016年，是一家致力于创新疫苗和新型佐剂研发、生产和商业化于一体的全球生物医药企业，下设6家子公司，现有员工超300人，获得国家级高新技术企业、四川省专精特新“小巨人”企业认定，连续入选GEI中国（潜在）独角兽企业榜单。迈科康生物针对传染性、过敏性疾病及肿瘤领域布局了多样化的产品研发管线，包括多个针对重大传染病的预防性疫苗，以及HPV感染、癌症等领域的治疗性疫苗，目前已有三项进入临床试验阶段。为推进新型佐剂和人用疫苗产业化进程，创新疫苗转产平台已基本建成，并启动了产业化基地的建设。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

疫苗临床研究

2024-10-18

·regimmune.com

REGiMMUNE and Kiji Therapeutics Announce Intention to merge

The intended merger will create a pan-global Treg specialist to use multiple modalities to target Tregs for a number of indications. Taipei, TAIWAN, and Paris, FRANCE, October 18, 2024 – REGiMMUNE, the regulatory T cell targeting drugs for immunotherapy and Kiji Therapeutics, the specialist in Induced Pluripotent Stem Cells-Mesenchymal Stem Cells (IPSC-MSC) engineered cell therapies for [...] TAIPEI, June 4, 2024 – REGiMMUNE Limited is pleased to announce that our company has recently been featured in a report by “China Times”. The article highlights our development progress of RGI-2001 and our future IPO plans. We are grateful for the attention and support from “China Times”. You can read the full article here: [...] TAIPEI, May 6, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, is pleased to announce the appointment of Dr. Steve Yang as its Chief Operating Officer (COO), effective on May 6th 2024. In this role, Dr. Yang will lead the company’s operational strategies, driving product [...] 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 [...] 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. [...] 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 [...] Taipei, July 6, 2023 – REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, today appointed Hua Nan Securities as the lead underwriter for its upcoming initial public offering (IPO) in Taiwan. The IPO is anticipated to take place in 2025, signifying an important milestone in REGiMMUNE's expansion [...] Taipei, March 29, 2023 – REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, and San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd. (4755.TW) have entered a licensing agreement to develop and commercialize RGI-2001 for the prophylaxis of acute Graft-versus-host disease (aGvHD) in major [...] RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GVHD TAIPEI, December 12, 2022 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company developing 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) [...] TAIPEI, November 3, 2022 – 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 49 patients receiving RGI-2001 for the prevention of acute graft-versus-host disease (aGVHD) will be presented at the 2022 American Society of Hematology (ASH) Annual Meeting [...] Taipei, 16 May 2022 – REGiMMUNE Limited, a biopharmaceutical company focused on creating innovative immunotherapies for rare diseases and cancer, today announced Charlie Hsu, a seasoned financial executive, join the company's management team as Chief Financial Officer (CFO). Charlie brings more than 25 years of business experience in finance management and equity investment in both [...] REGiMMUNE Corporation has presented clinical data on RGI-2001 Intravenous Infusion for the prevention of acute GVHD in the annual meeting of the American Society of Hematology on December 5 2020. Repeat weekly doses of RGI-2001 100 μg/kg IV infusion (30min) in allogeneic bone marrow transplant is safe when given with standard GvHD prophylaxis [...] Tokyo, Japan – April 7, 2017 – REGiMMUNE Corporation announced the closing of a Series E financing on April 7th. The company raised 6 million US in this new round, which was led by SMBC Venture Capital Co., Ltd., the VC arm of Sumitomo Mitsui Banking Corporation(SMBC) and Japan Asia Investment Corporation (JAIC). Additional investors [...] We are proud to announce that we have moved our business to a new location. Our new address is as follows. 35-3 Nihonbashi Hakozaki-cho BRICK GATE 5F Chuou-ku Tokyo 103-0015 Japan.Our Telephone numbers remain the same. Tokyo Japan — July 1, 2016 — REGiMMMUNE today announced that its Board of Directors has appointed Kenzo Kosuda as Chief Executive Officer effective July 1, 2016. Yasuyuki Ishii will assume the role of Executive Chairman on July 1, 2016, and will continue to serve as the Chairman of REGiMMUNE’s Board. "This is an appropriate [...]

临床2期高管变更免疫疗法引进/卖出

2024-06-04

·regimmune.com

REGiMMUNE Featured in “China Times”

TAIPEI, June 4, 2024 – REGiMMUNE Limited is pleased to announce that our company has recently been featured in a report by “China Times”. The article highlights our development progress of RGI-2001 and our future IPO plans. We are grateful for the attention and support from “China Times”. You can read the full article here: 櫃買赴日招商聚焦生技業 We will continue our commitment to developing RGI-2001 and other innovative drugs in the fields of immunology and oncology. Ends 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6月4日，台北 – 瑞格國際生技很高興宣布，近日獲得「中時新聞網」的報導，該報導介紹了本公司RGI-2001的開發進度及未來掛牌規劃，感謝「中時新聞網」的關注與支持。完整報導請見以下連結：櫃買赴日招商聚焦生技業我們將致力於推展RGI-2001的研發，並在免疫及癌症領域開發更多創新藥物。本文結束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

免疫疗法

100 项与 KRN-7000 liposomal 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12232

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
移植物抗宿主病	临床2期	日本	REGiMMUNE Corp.	2022-01-30
血液肿瘤	临床2期	日本	REGiMMUNE Corp.	2022-01-30
急性移植物抗宿主病	临床2期	美国	REGiMMUNE Corp.	2019-11-25
慢性丙型肝炎	临床2期	荷兰	Kyowa Kirin Co., Ltd.	2003-08-01
急性淋巴细胞白血病	临床1期	美国	REGiMMUNE Corp.	2020-08-14
急性髓性白血病	临床1期	美国	REGiMMUNE Corp.	2020-08-14
慢性粒单核细胞白血病	临床1期	美国	REGiMMUNE Corp.	2020-08-14
霍奇金淋巴瘤	临床1期	美国	REGiMMUNE Corp.	2020-08-14
骨髓增生异常综合征	临床1期	美国	REGiMMUNE Corp.	2020-08-14
骨髓增生性疾病	临床1期	美国	REGiMMUNE Corp.	2020-08-14

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04014790 (RGI-2001-003, CTgov)	临床2期	急性移植物抗宿主病	49	Standard of Care+RGI-2001	繭艱構選醖窪網積蓋齋 = 鹽鹹觸糧窪願簾窪淵餘積襯網醖鬱繭繭膚齋構 (鏇網壓積範齋構觸窪廠, 繭鹹構築襯糧醖網獵願 ~ 衊鏇鑰膚鬱鹽觸艱鹹衊) 更多	-	2024-04-17
NCT04014790 (Company_Website) 人工标引	临床2期	急性移植物抗宿主病	-	RGI-2001 + standard immunosuppression	鑰餘構壓鹽憲繭窪製積(願艱憲範遞鏇構鏇憲觸) = 艱鹽鹹築鬱積選範鹹窪網鬱範範糧鹽衊願鹽積 (製蓋選鬱繭醖網醖顧鏇 ) 更多	积极	2024-02-22
NCT04014790 (Company_Website) 人工标引	临床2期	急性移植物抗宿主病	-	CIBMTR cohort	鑰餘構壓鹽憲繭窪製積(願艱憲範遞鏇構鏇憲觸) = 膚醖製廠衊鑰顧襯製鹽網鬱範範糧鹽衊願鹽積 (製蓋選鬱繭醖網醖顧鏇 ) 更多	积极	2024-02-22
NCT04014790 (RGI-2001-003, EBMT2023)	临床2期	急性移植物抗宿主病	49	RGI-2001 IV infusion	淵獵憲簾鏇艱醖範構鏇(觸製襯膚糧鏇夢獵糧鹹) = 範衊憲夢廠衊夢艱繭鑰淵遞簾積鏇糧網簾積構 (壓鹹鏇積網壓築衊壓鏇, 10.2 ~ 34.3)	-	2023-04-23
NCT04014790 (RGI-2001-003, Tandem Meetings ASTCT and CIBMTR2023)	临床2期	急性移植物抗宿主病	49	RGI-2001	築積夢醖遞衊鹽醖齋餘(簾廠襯齋窪鹽遞願餘簾) = 6% 選膚壓艱衊壓繭鹽醖鹹 (獵築選衊選網鬱顧獵鹹 ) 更多	积极	2023-02-01
NCT04014790 (RGI-2001-003, ASH 12022 \| ASH 22022) 人工标引	临床2期	急性移植物抗宿主病	53	RGI-2001 100 ug/kg	餘膚鑰窪遞衊鑰顧繭繭(顧膚鬱壓壓艱遞網製艱) = 願觸鏇鑰鏇願觸鬱齋膚膚鬱簾壓蓋壓選蓋壓繭 (顧築獵觸鹽壓遞夢簾獵, 10.2 ~ 34.3) 更多	积极	2022-11-15