Business Wire

REGiMMUNE Limited Licenses the Rights to Develop and Commercialize RGI-2001 To San Fu Biotech in Major Asian Countries

Share

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.

Contact information

Charlie Hsu
Chief Financial Officer
REGiMMUNE Ltd.
Tel: +886 2 2555 3377 #511
Email: charlieh@regimmune.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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: DANSKA RESTRIKTIONER PÅ NIKOTINPORTIONER KOMMER ATT TVINGA 150 000 TILLBAKA TILL RÖKNING6.10.2024 17:00:00 CEST | Pressmeddelande

ETT FÖRESLAGET FÖRBUD mot nio av tio nikotinpåsar i Danmark kommer att vara ett massivt bakslag i kampen mot tobak och kommer att driva tiotusentals före detta rökare tillbaka till dödliga cigaretter, varnar internationella experter idag Hälsoreformregler som ska presenteras för det danska parlamentet på fredag (11 oktober) skulle begränsa nikotininnehållet i en portion till 9 mg, långt under internationella standarder – och en bråkdel av nikotinnivån i traditionella cigaretter. Dr. Delon Human, en global expert på skadereduktion och ledare för Smoke Free Sweden, säger: "Nikotinportioner har visat sig vara ett mycket säkrare alternativ till cigaretter och hjälper miljontals rökare att sluta över hela världen. "Förslaget framför de danska riksdagsledamöterna kommer att förbjuda 90% av de portioner som för närvarande används i Danmark, vilket lämnar rökare med valet mellan de portioner som återstår eller cigaretter som innehåller 85% mer nikotin. “Det är inte svårt att förutspå vilket al

C5 Capital Partners with Ukraine’s Brave1 Accelerator to Advance Ukraine’s Defense Innovation4.10.2024 17:46:00 CEST | Press Release

C5 Capital, a specialist venture capital firm based in Washington DC and London announces a strategic partnership with Brave1, Ukraine’s premier defense technology accelerator. This collaboration will support Ukraine’s innovative tech startups, accelerating the development and application of critical technologies for the defense of Ukraine against Russian aggression. Brave1 leads Ukraine’s defense innovation ecosystem. Since its launch, the accelerator has evaluated more than 2,600 cutting-edge defense-focused innovations. This remarkable achievement has established Ukraine as emerging global leader in defense technology and innovation. C5 Capital’s partnership will provide investment capital and strategic expertise needed to help Ukrainian founders grow and scale their defense startups, whose innovations are already being tested and deployed in battlefield conditions. “C5 Capital’s strategic partnership with Brave1 is focused on empowering Ukraine’s courageous founders, who are buildi

TXOne Networks Expands Edge Series of OT-Native Network Security Appliances4.10.2024 10:49:00 CEST | Press Release

TXOne Networks, a leader in Cyber-Physical Systems (CPS) security, today announced Version 2.1 of its Edge series of networking security appliances. designed to protect industrial processes and infrastructure without disrupting operations. This update enhances network resilience and adaptability across a wider range of industrial verticals. “Our Edge series is specifically engineered for the complexities of OT networks, where traditional IT cybersecurity solutions fall short,” said Dr. Terence Liu, CEO of TXOne Networks. “With version 2.1, we’ve elevated the Edge product line to address the unique challenges faced by OT environments—where disruption isn’t an option. This release underscores our commitment to delivering robust, adaptable security that not only meets current demands but anticipates the evolving needs of industrial operations.” TXOne Networks collaborates with manufacturers and critical infrastructure operators to protect over 3,600 organizations worldwide. The Edge V2.1

WELOCK and ApartX Ink Key China-Kazakhstan Digital Trade Agreement at Global Digital Trade Expo4.10.2024 03:54:00 CEST | Press Release

On September 25th, the 3rd Global Digital Trade Expo “Digital Trade Night” was held in Hangzhou. The event highlighted important digital trade projects between China and Kazakhstan, injecting constant momentum into economic and trade cooperation between the two sides. During the event, the much-anticipated signing ceremony for the “China-Kazakhstan Digital Trade Key Project” was officially launched. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241003595967/en/ (Photo: Business Wire) Important witnesses of the signing ceremony included: Zhaslan Madiyev (Minister) Ministry of Digital Development, Innovations and Aerospace Industry of the Republic of Kazakhstan Yao Gaoyuan Mayor of Hangzhou Avazhan Mukanova (Director of the Department of International Cooperation) Ministry of Digital Development, Innovations and Aerospace Industry of the Republic of Kazakhstan Shuang Dehui Deputy Director General of Guangdong Provincial Depar

Wrth: The Royal Institute of Traditional Arts Captivates Greece with the Intricate 'Al-Qatt Al-Asiri’ Art3.10.2024 18:01:00 CEST | Press Release

Saudi traditional arts are set to reach new global audiences as the Royal Institute of Traditional Arts (Wrth) participates in the Saudi Cultural Week in Greece from September 27 to October 1. The event, titled “The Heritage of Two Cultures," explores Saudi heritage through the lens of "Al-Qatt Al-Asiri" art. Wrth offers a series of interactive workshops, including a highlight on the creation of natural dyes and gypsum carving arts with workshops and hands-on community artworks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241003645976/en/ Wrth: The Royal Institute of Traditional Arts Captivates Greece with the Intricate 'Al-Qatt Al-Asiri’ Art (Photo: AETOSWire) As part of Culture Week, five talented Saudi artists lead interactive workshops showcasing the art of gypsum carving with traditional ‘Asiri’ patterns. This unique art form gained international recognition after being inscribed on UNESCO's Intangible Cultural Herit

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
HiddenA line styled icon from Orion Icon Library.Eye