REGIMMUNE-LIMITED
1.4.2023 18:19:26 CEST | Business Wire | Press release
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 Asian countries.
RGI-2001, with the novel mechanism to improve existing treatments, is a potentially first-in-class small molecule drug candidate targeted for preventing aGvHD, a life-threatening complication resulting from allogeneic hematopoietic stem cell transplantation (HSCT). GvHD is a systemic disorder that occurs when the graft's immune cells recognize the host as foreign and attack the recipient’s body cells or organs, and leads to skin rash, liver problems, abdominal pain or cramps, diarrhea, and increased risk for infections. Patients undergoing allogeneic HSCT have a high-risk of developing aGVHD associated with significant morbidity and mortality. Despite the use of prophylactic immunosuppressive therapy, clinically significant aGvHD develops in 20%-40% of HLA-matched related and unrelated allogeneic HSCT and severe cases contribute to non-relapse mortality.
Under the terms of agreement, REGiMMUNE and SFB will collaborate closely to accelerate the development of RGI-2001 in major Asian countries and will conduct clinical trials to study the efficacy of the drug in aGvHD. Together, both parties intend to submit an Investigational New Drug Application to the Taiwan Food and Drug Administration to initiate clinical trials in Taiwan for the prophylaxis of aGvHD before the end of 2023. SFB will pay to REGiMMUNE development milestones and royalties on net profit upon successful commercialization of RGI-2001. SFB also retains the first rights of negotiation to develop and commercialize RGI-2001 for new indications in the authorized territories.
RGI-2001 of REGiMMUNE, awarded Orphan Drug Designation by the US FDA in GvHD in 2012, has completed the phase II clinical trial targeting at the prophylaxis of aGvHD in the US. The efficacy and safety results were positive. Furthermore, RGI-2001 was selected for oral presentation at the American Society of Hematology (ASH) annual meeting in December 2022 and planned to submit phase III IND to US FDA in Q4 of 2023.
Kenzo Kosuda, Chief Executive Officer and President, REGiMMUNE Limited, said: “This agreement underscores our focus and commitment to improve the incumbent therapies of aGvHD prevention and treatment. The fast-growing patients with GvHD in Asia create a high unmet need for more effective treatments.”
“We are pleased to collaborate with SFB and San Fu Chemical Group which has a long history in Taiwan. The Group’s abundant biomedical resources, expertise and innovative strategy make San Fu a strong commercial partner for REGiMMUNE in Asia. Together, we look forward to expediting the development of RGI-2001 in this important market.”
Simon H.H. Wu, SFB & San Fu Chemical Group Chairman, emphasized: “We are excited to add RGI-2001 to our growing portfolio of innovative therapeutic agents. This enhances our autoimmune pipeline and aligns with our long-term research and development strategy. RGI-2001 has demonstrated promising results in phase II studies in the US and we look forward to working together with REGiMMUNE to deliver treatments that will benefit the lives of patients.”
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.
About San Fu Biotech
San Fu Biotech, a wholly-owned subsidiary of San Fu Chemical, develops first-in-class new drugs to address unmet medical needs, such as cancer tumors, autoimmune disease and ophthalmology, for benefiting patients around the world.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230401005026/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Smoke Free Sweden: Brussels Warned Against Depriving Women of Best Tool to Quit Smoking6.3.2026 10:28:00 CET | Press release
On International Women’s Day (March 8), health experts are warning EU policymakers not to jeopardise women’s health by restricting or banning nicotine pouches that have helped drive one of the world’s most dramatic declines in female smoking. The warning accompanies the release of Empowerment in a Pouch, a report showing how access to oral, tobacco-free nicotine pouches has accelerated Sweden’s progress towards smoke-free status, particularly among women. European Commission proposals under consideration in the Tobacco Products Directive could reverse this progress if applied across the EU, where more than one in five women still smokes. “Sweden’s experience shows what happens when women are given realistic alternatives to smoking,” said Professor Marewa Glover, behavioural scientist and co-author. “Remove those options and you remove momentum. The danger now is that European policy ignores success and repeats past mistakes.” The report shows that since nicotine pouches became availabl
Andersen Consulting udvider platformen med Reach Consulting5.3.2026 22:05:00 CET | Pressemeddelelse
Andersen Consulting udvider sin platform i Mellemøsten gennem en samarbejdsaftale med Reach Consulting, et digitalt transformations- og rådgivningsfirma med hovedsæde i De Forenede Arabiske Emirater. Reach Consulting hjælper organisationer med at skabe vækst, håndtere risici og navigere i komplekse forandringer gennem en omfattende portefølje af ydelser, herunder digital transformation, strategi, intern revision og M&A-rådgivning. Med en tilstedeværelse i De Forenede Arabiske Emirater, Saudi-Arabien, Oman, Qatar og Jordan betjener firmaet kunder i både den offentlige og private sektor med skræddersyede løsninger, tværfaglig ekspertise og indgående lokalkendskab. Reach Consulting kombinerer skala med agilitet for at fremme driftsresultater og innovation i arbejdsstyrken. "Transformation fungerer bedst, når lokal indsigt, tværfaglig ekspertise og praktisk udførelse spiller sammen," udtalte Suhail Shaker, administrerende direktør for Reach Consulting. "Ved at samarbejde med Andersen Consu
2PointZero Group Completes Majority Acquisition in Italy-Based ISEM Packaging Group for AED 704 Million5.3.2026 22:02:00 CET | Press release
Transaction results in 60.8% ownership by 2PointZero Packaging becomes the sixth consumer-focused vertical with ISEM as an anchor 2PointZero Group PJSC (ADX: 2PointZero), a next-generation investment powerhouse focused on energy and consumer sectors, announced today that it has formally completed the transaction to acquire a majority position in ISEM, a leading European packaging group serving beauty, fashion, luxury, nutraceuticals and more, for AED 704 million through a combination of secondary and primary capital earmarked to accelerate organic and inorganic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305800523/en/ 2PointZero Group completes majority acquisition in Italy-based ISEM Packaging Group for AED 704 million (Photo: AETOSWire) 2PointZero Group now holds 60.8% of ISEM, while Peninsula Capital and minority investors own the remaining 39.2%. This marks the start of a strategic partnership between 2Poin
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 18:00:00 CET | Press release
Game Developers And Publishers Can Now Reach More Players By Partnering with Official Distributors And Resellers Globally Without Building Local Infrastructure Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local di
Andersen Consulting styrker sine kompetencer inden for cybersikkerhed gennem samarbejde med A3Sec5.3.2026 17:16:00 CET | Pressemeddelelse
Andersen Consulting styrker sine tilbud inden for cybersikkerhed og teknologisk transformation gennem en samarbejdsaftale med A3Sec, et firma, der specialiserer sig i datadrevet trusselsdetektion, hændelsesrespons og exposure management. Med hovedsæde i Spanien og kontorer i Mexico og Colombia har A3Sec mere end 14 års erfaring med at hjælpe offentlige og private organisationer inden for finans, telekommunikation, energi, den offentlige sektor og erhvervslivet med at sikre deres digitale aktiver. Virksomheden driver sit Security and Digital Surveillance Center® (CSVD®) døgnet rundt med et team på over 180 cybersikkerhedseksperter og betjener mere end 280 kunder verden over. Firmaet leverer integrerede cybersikkerhedstjenester, herunder managed detection and response, cybertelemetri, trusselsanalyse og krisestyring, og hjælper kunder med at styrke deres robusthed og omdanne risiko til en strategisk fordel, samtidig med at de effektivt håndterer eksponering og minimerer risiko. "Vores fo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom