TAIPEI, Taiwan–(BUSINESS WIRE)– REgiMMUNE Limited, een biofarmaceutisch bedrijf in de klinische fase dat zich richt op het creëren van innovatieve immunotherapieën voor immuunaandoeningen en kanker, heeft vandaag aangekondigd dat de klinische fase 2b-gegevens van 49 patiënten die RGI-2001 kregen voor de preventie van acute graft -versus-host ziekte (aGVHD) zal worden gepresenteerd op de 2022 American Society of Hematology (ASH) jaarlijkse bijeenkomst in New Orleans, Louisiana op 12 december 2022.

Dit is een open-label, eenarmige fase 2-studie, waarin de veiligheid en werkzaamheid van RGI-2001 voor de preventie van aGVHD bij proefpersonen na allogene hematopoëtische stamceltransplantatie (HSCT) worden geëvalueerd. Deze studie test de hypothese dat RGI-2001 GVHD voorkomt door regulerende T-cellen kort na allogene HSCT uit te breiden. De incidentie en ernst van aGVHD werd geëvalueerd bij patiënten die werden behandeld met RGI-2001 in aanvulling op standaard GVHD-preventiemedicatie. “Op basis van de analyse toonde RGI-2001 een verminderde incidentie van aGVHD met een uitstekend veiligheidsprofiel. Ik ben verheugd dat de onderzoeksresultaten van RGI-2001 zijn geselecteerd voor mondelinge presentatie op de ASH-bijeenkomst. We kijken ernaar uit om toekomstige bevindingen te delen terwijl we werken aan het leveren van baanbrekende immuungeneesmiddelen door gebruik te maken van de kracht van regulerende T-cellen”, zegt Kenzo Kosuda, CEO van REgiMMUNE Limited.

REGiMMUNE to Present Results from the Phase 2b Study of RGI-2001 at the 2022 American Society of Hematology Annual Meeting

TAIPEI, Taiwan–(BUSINESS WIRE)– 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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Contacts

Charlie Hsu

Chief Financial Officer

REGiMMUNE Corporation Ltd.

+886 2 2555 3377 #511

charlieh@regimmune.com