Taiwan-based biotechnology company REGiMMUNE Ltd has announced the signing of an out-license agreement with San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd (TPE: 4755). Under the terms of the deal, REGiMMUNE will transfer the development and commercial rights of its pipeline candidate, RGI-2001, to SFB for major markets in Asia. RGI-2001 is being developed as a prophylaxis for acute graft-versus-host disease (aGvHD).
RGI-2001: A Potential First-in-Class Treatment for aGvHD
RGI-2001 is a small-molecule drug with a novel mechanism of action, which positions it as a potentially first-in-class therapy for the prevention of aGvHD. This condition is associated with allogeneic hematopoietic stem cell transplantation (HSCT) and RGI-2001 is expected to offer improvements over current prevention therapies. The drug has already received orphan drug designation from the US FDA in 2012 and has successfully completed Phase II trials in the United States, showing positive results.
Collaboration and Development Plans
REGiMMUNE and SFB will collaborate on the further development of RGI-2001, with plans to file an Investigational New Drug (IND) application with Taiwan’s Food and Drug Administration before the end of 2023. Financial terms of the agreement include development milestones and royalties on future net sales, the specifics of which have not been disclosed.
Significance of aGvHD and Unmet Needs
GvHD occurs when the immune cells from the graft recognize the host’s body as foreign and initiate an attack on the recipient’s cells or organs. Patients who develop aGvHD following allogeneic HSCT face a significantly increased risk of mortality. Clinically, aGvHD develops in 20-40% of HLA-matched related and unrelated allogeneic HSCT cases, highlighting a significant unmet need in the market for more effective prophylactic treatments.-Fineline Info & Tech
