REGiMMUNE Limited Licenses the Rights to Develop and Commercialize RGI-2001 To San Fu Biotech in Major Asian Countries
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/
Contact information
Charlie Hsu
Chief Financial Officer
REGiMMUNE Ltd.
Tel: +886 2 2555 3377 #511
Email: charlieh@regimmune.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Lausanne University Hospital (CHUV) Anesthesiology Department Adopts Masimo W1™ for Use in Preoperative Patient Assessment8.6.2023 16:55:00 EEST | Press release
Masimo (NASDAQ: MASI) today announced that the Department of Anesthesiology at the Lausanne University Hospital (CHUV), one of Switzerland’s premier academic institutions, has chosen to make the Masimo W1™ advanced health tracking watch a key part of its pre-surgical patient assessment research program. This initiative, led by Professor Patrick Schoettker, Head of Anesthesiology at CHUV and a renowned expert in airway management, wireless monitoring, and the digital transformation of healthcare, is designed to help better inform anesthesiologists and surgical teams about their patients’ physiological status prior to surgery, with the ultimate goal of improving patient outcomes. Masimo W1, which offers accurate, continuous measurements of key physiological parameters, is available in Europe as a medical device that integrates with the Masimo SafetyNet® remote patient management platform. This press release features multimedia. View the full release here: https://www.businesswire.com/new
Berger Montague (Canada) PC Announces Shareholder Investigation Into Standard Lithium Ltd.8.6.2023 16:30:00 EEST | Press release
Berger Montague (Canada) P.C. is announcing that it has been directed by its clients to investigate Standard Lithium Ltd. (“Standard Lithium) (TSX: “SLI” and FRA: “S5L”) concerning its Third Quarter 2023 Results. Standard Lithium held itself out as focused on commercializing its “proprietary” direct lithium extraction process, which the company claimed could achieve the remarkable recovery rate of about 90% of lithium extracted from brine. On November 18, 2021, Blue Orca hedge fund published a report revealing that, among other things, Standard Lithium was far from achieving proof of concept at 90%. On February 3, 2022, Hindenburg hedge fund re-confirmed the Blue Orca report that Standard Lithium indeed had not achieved proof of concept. On November 9, 2022, Standard Lithium released its quarterly report ending September 30, 2022, that may have acknowledged the statements from November 18, 2021 and November 9, 2022. If you purchased Standard Lithium's securities on the Toronto and Bors
Cirium and Aireon Extend Partnership to Offer Live and Historical Aircraft Positional Analytics8.6.2023 16:29:00 EEST | Press release
Cirium, the aviation analytics company, has extended its long-term agreement with Aireon, the leader in space-based aircraft tracking, to offer live and historical aircraft positional analytics for advanced situational awareness and post-operations analysis. As Aireon’s selected partner to bring these analytics to market, Cirium is integrating its own industry-leading schedule, fleet, flight status, weather and emissions data with Aireon’s global satellite-based coverage of flight positions to create a fully comprehensive stream of gate-to-gate data. Aireon’s satellite-based positional data ensures complete coverage of all modern aircraft, equipped with ADS-B, anywhere in the world, including aircraft flying at low altitudes, over oceans or mountainous regions, which cannot be tracked via ground-based receivers. The enriched level of aircraft positional information will give airlines full visibility across their networks, helping to enhance operational efficiency, reduce fuel burn and
Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the Signs and Symptoms of Dry Eye Disease8.6.2023 16:23:00 EEST | Press release
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005090/en/ Novaliq Announces FDA Approval of VEVYE™ (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease (Photo: Business Wire) “We are proud that FDA approved VEVYE. The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE. VEVYE and its novel vehicle were safe, well toler
Pyramid Analytics added to the DoD’s Tradewind Solutions Marketplace8.6.2023 16:07:00 EEST | Press release
Pyramid Analytics (Pyramid), a leading business analytics and decision intelligence provider, is pleased to announce that its Pyramid Decision Intelligence Platform has been added to the Tradewind Solutions Marketplace, DoD’s digital environment of post-competition, readily awardable, technology solution pitch videos. The Tradewind Solutions Marketplace is the flagship offering of Tradewind, DoD’s suite of tools and services designed to accelerate the procurement and adoption of AI/ML, digital, and data analytics solutions across the DoD. Tradewind sits in the DoD’s Chief Digital Artificial Intelligence Office (CDAO). The Pyramid Platform provides comprehensive, advanced analytics capabilities, including data pipelines and preparation (with embedded machine learning), enterprise and self-service data analytics, dashboarding (with built-in AI and chat-bots), and data science. Pyramid’s platform was rated as “Awardable” and added to the Tradewind Solutions Marketplace. Solutions selected
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