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
AIT Worldwide Logistics Announces Strategic Partnership With Greenbriar Equity Group16.2.2026 15:03:00 CET | Press release
Agreement supports continuity, accelerating next phase of AIT’s growth plan Supply chain solutions leader AIT Worldwide Logistics (“AIT”) has entered into a definitive agreement to partner with Greenbriar Equity Group, L.P. (“Greenbriar”) in support of the global freight forwarder’s next chapter of growth. Financial terms of the private transaction were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260216984391/en/ AIT Worldwide Logistics' strategic partnership with Greenbriar Equity Group represents one of the largest private acquisitions ever in the global freight forwarding sector. The deal marks the culmination of five successful years with The Jordan Company, L.P. (“TJC”). TJC, alongside key members of AIT’s executive leadership team, will remain invested in the company. Over the course of the company’s relationship with TJC, AIT has dramatically expanded its global footprint, acquired 14 businesses, and
Compass Pathways to Announce New Clinical Data from Two Ongoing Phase 3 Trials16.2.2026 14:00:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced that tomorrow it will report new clinical data from two ongoing Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The company will be disclosing new clinical data from Part A and Part B from COMP005 and Part A from COMP006. The results are scheduled for release on February 17th at 6:30 am ET, followed by a webinar hosted by Compass management at 8:00 am ET. Live Webcast Compass management will host a live audio webcast on February 17th at 8:00 am ET. The webcast will be accessible at this link: https://lifescievents.com/event/hz02j0rpw/ A replay of the webcast will be accessible for 30 days following the event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in m
Transition Industries and Mexico’s CFEnergía Sign Natural Gas Supply Contract Enabling Construction of Pacifico Mexinol, the World’s Largest Ultra-Low Carbon Methanol Plant16.2.2026 14:00:00 CET | Press release
The long-term contract guarantees operational readiness and enables the start of construction in the second quarter of 2026 The project positions Mexico as a reliable supplier of ultra-low carbon methanol for strategic global markets Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and hydrogen projects, and CFEnergía, a subsidiary of Mexico’s Federal Electricity Commission (CFE), announced the signing of a long-term firm natural gas supply contract for the Pacifico Mexinol (“Mexinol”) project, located near Topolobampo, Sinaloa. Under this agreement, CFEnergía will supply approximately 160 million cubic feet per day (MMcfd) of natural gas over the long term, ensuring a critical input for Mexinol’s production of ultra-low carbon methanol. The supply will be provided by CFEnergía at market prices and will optimize the use of existing infrastructure. CFEnergía will source the natural gas from the USA. The agreement is subject to customary condition
K2 Partnering Solutions Appoints Srinivas Rao as Chief Executive Officer16.2.2026 10:00:00 CET | Press release
K2 Partnering Solutions, a global leader in consultative technology and talent solutions, today announced the appointment of Srinivas Rao as Chief Executive Officer. Srinivas is a seasoned global executive with more than 28 years of experience driving value creation, scalable growth, and operational transformation across digital, consulting, IT services, and business services. He brings deep expertise in leading complex, multi-market organisations and has successfully scaled $800M+ P&Ls, working closely with boards, sponsors, and executive leadership teams across the USA, UK, Europe, the Middle East, and APAC. Most recently, Srinivas served as Chief Business Officer and a member of the Executive Council at LTIMindtree, where he was accountable for growth acceleration, market expansion, strategic customer relationships, and operating performance across a highly complex regional footprint. During his tenure, he played a pivotal role in strengthening go-to-market execution, driving margin
Italy Sees Economic Boost From the Opening Weekend of the Olympic Winter Games Milano Cortina 202616.2.2026 09:00:00 CET | Press release
Northern Italy sees more than 60% increase in Visa cardholder visitors from overseas, with an increase in purchases up 80% compared to the same period in 2025 Significant increase in spending from Visa cardholders in many areas of commerce including Clothing & Accessories, Restaurants and Mobility & Transport Biggest share of spend comes from U.S. Visa cardholders, with most significant increases in year-on-year spending from Canada and Switzerland Visa, the Official Payment Technology Partner of the Olympic and Paralympic Winter Games, today released new data revealing consumer spending patterns in the Winter Games host locations1 during the opening weekend of the Olympic Winter Games Milano Cortina 2026. VisaNet data analysed by Visa Consulting & Analytics (VCA) shows the positive impact that Milano Cortina 2026 is having on commerce: Overseas Visa cardholders visits rose by more than 60%, with the largest share of visitors coming from the U.S. (+160% year-on-year), followed by China
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