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TAIPEI, Taiwan

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 in New Orleans, Louisiana on December 12, 2022.

This is an open label, single-arm 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 ASH 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 at REGiMMUNE Limited.

Session Name: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Novel Therapies for Graft-versus-Host Disease
Session Date and Time: Monday, December 12, 2022, 10:30 – 12:00 p.m. CT
Presentation time: 11:45 a.m. CT
Location: Ernest N. Morial Convention Center, 252-254 and online
Presenter: Yi-Bin Chen, MD

Publication Number: 774
Title: RGI-2001 Infusion for Prevention of Acute GVHD after Allogeneic Hematopoietic Cell Transplantation
Submission ID: 162512

About RGI-2001

RGI-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). 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.

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