{"id":52158,"date":"2022-12-20T07:02:22","date_gmt":"2022-12-20T06:02:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/regimmune-presented-positive-results-of-rgi-2001-in-the-reduction-of-acute-gvhd-from-phase-2b-study-at-the-2022-ash-annual-meeting\/"},"modified":"2022-12-20T07:02:22","modified_gmt":"2022-12-20T06:02:22","slug":"regimmune-presented-positive-results-of-rgi-2001-in-the-reduction-of-acute-gvhd-from-phase-2b-study-at-the-2022-ash-annual-meeting","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/regimmune-presented-positive-results-of-rgi-2001-in-the-reduction-of-acute-gvhd-from-phase-2b-study-at-the-2022-ash-annual-meeting\/","title":{"rendered":"REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH Annual Meeting"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<b><i>RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GvHD<\/i><\/b>\n<\/li>\n<\/ul>\n<p>TAIPEI, Taiwan&#8211;(BUSINESS WIRE)&#8211;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) after allogeneic hematopoietic cell transplantation (HCT) at the 2022 American Society of Hematology (ASH) Annual Meeting. RGI-2001 activates Regulatory T-cells (Tregs) through a novel mechanism that may have implications for the treatment of other autoimmune and chronic inflammatory diseases.\n<\/p>\n<p>\nPatients who undergo HCT have a high-risk of developing aGVHD which is associated with significant morbidity and mortality. Acute GVHD is characterized as a reaction of donor immune cells against host tissues. Despite the use of prophylactic immunosuppressive therapy, clinically significant aGvHD develops in 20%-40% of matched related and unrelated allogenic HCT and severe cases contribute to non-relapse mortality. RGI-2001, added to standard immunosuppression, is being evaluated for the potential to reduce or prevent aGvHD after HCT. Earlier studies had shown that a single dose of RGI-2001 given on the day of transplantation was safe and potentially contributed to aGvHD prevention.\n<\/p>\n<p>\n\u201cWe are very excited about the RGI-2001 data and the potential to better prevent acute GVHD, which will benefit patients and reduce the risk of morbidity and mortality. RGI-2001 is an innovative therapy that may have a role in GVHD prevention.\u201d said Dr. Yi-Bin Chen, Associate Professor of Medicine, Harvard Medical School and Director. Hematopoietic Cell Transplant and Cell Therapy Program, Massachusetts General Hospital.\n<\/p>\n<p>\n\u201cWe are definitely encouraged by the positive results from this study; it also provides a strong foundation to confidently advance our plans for phase 3 study.\u201d said Kenzo Kosuda, CEO of REGiMMUNE.\n<\/p>\n<p>\nThis phase 2b clinical trial was an open-label, multi-center, single-arm study to evaluate six weekly doses of RGI-2001 in combination with standard of care tacrolimus\/methotrexate for the prevention of aGvHD in patients following allogenic HCT. RGI-2001 was administered at a dose of 100 ug\/kg IV infusion weekly for 6 weeks, starting on the day of transplantation. The study included 49 patients and was conducted in the US at 7 centers.\n<\/p>\n<p>\n<b>Efficacy Results from the phase 2b trial in allogenic HSCT patients:<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAll 49 patients had at least 100 days of follow-up after HCT, and 39 of 49 had complete follow-up to day 180. The median follow-up of survivors was 310 days (range 111-365 days)\n<\/li>\n<li>\nThere were no cases of engraftment failure and no serious adverse events attributed to RGI-2001; and treatment emergent adverse events (&gt;10%) include gastrointestinal AE such as diarrhea, stomatitis and nausea.\n<\/li>\n<li>\nThrough day 100, the incidence of grades II-IV aGvHD was 20.4% (95% confidence interval 10.2-34.3%), only 2 cases of which were grades III-IV aGvHD [(4.1% (0.5-14.0%)).\n<\/li>\n<li>\nAt day 180, estimates of overall survival, grades II-IV aGvHD-free survival, and disease relapse were 93.6% (81.6-97.9%), 75.2% (60.5-85.1%), and 4.1% (0.7-12.6%), respectively.\n<\/li>\n<\/ul>\n<p>\nREGiMMUNE concludes that intravenous administration of RGI-2001 added to standard-of-care tacrolimus\/methotrexate showed promising efficacy in the prevention of clinically significant aGvHD with a favorable safety profile. Based on these compelling phase 2b results, REGiMMUNE is strongly considering moving forward with a phase 3 study.\n<\/p>\n<p>\nFor more information, please find <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fregimmune.com%2Fwp-content%2Fuploads%2F2022%2F12%2F20221212-RGI-2001-003-ASH-Oral-presentation-Final.pdf&amp;esheet=53098243&amp;newsitemid=20221219005846&amp;lan=en-US&amp;anchor=RGI-2001-003+ASH+Oral+Presentation&amp;index=1&amp;md5=bbb14149b16ca6a30164875bcfdc6757\" rel=\"nofollow noopener\" shape=\"rect\">RGI-2001-003 ASH Oral Presentation<\/a>.\n<\/p>\n<p>\n<b>About RGI-2001<\/b>\n<\/p>\n<p>\nRGI-2001 is a liposomal formulation of an alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer is a ligand for CD1d expressed on antigen presenting cells and invariant natural killer T cells (iNKT). Liposomal alpha-GalCer promotes tolerogenic immune cascades, resulting in the activation and expansion of regulatory T cells (Tregs).\n<\/p>\n<p>\nRGI-2001 is REGiMMUNE\u2019s lead drug candidate currently in Phase 3 planning for the prophylaxis of acute graft-versus-host disease (aGVHD).\n<\/p>\n<p>\n<b>About REGiMMUNE Limited<\/b>\n<\/p>\n<p>\nREGiMMUNE 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.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nCorporate:\n<\/p>\n<p>\nCharlie Hsu<br \/>\n<br \/>Chief Financial Officer<br \/>\n<br \/>REGiMMUNE Corporation Ltd.<br \/>\n<br \/>+886 2 2555 3377 #511<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#108;&#116;o:&#x63;&#x68;&#x61;&#114;&#108;ie&#x68;&#x40;&#x72;&#101;&#103;im&#x6d;&#x75;&#x6e;&#101;&#46;co&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x63;&#104;&#x61;&#114;l&#x69;&#101;h&#x40;&#114;&#x65;&#x67;i&#x6d;&#109;u&#x6e;&#101;&#x2e;&#x63;o&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GvHD TAIPEI, Taiwan&#8211;(BUSINESS WIRE)&#8211;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) after allogeneic hematopoietic &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/regimmune-presented-positive-results-of-rgi-2001-in-the-reduction-of-acute-gvhd-from-phase-2b-study-at-the-2022-ash-annual-meeting\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-52158","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH Annual Meeting - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/regimmune-presented-positive-results-of-rgi-2001-in-the-reduction-of-acute-gvhd-from-phase-2b-study-at-the-2022-ash-annual-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH Annual Meeting - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GvHD TAIPEI, Taiwan&#8211;(BUSINESS WIRE)&#8211;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) after allogeneic hematopoietic ... 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