REGiMMUNE Limited, a biotechnology company focused on developing innovative immunotherapies for immune disorders and cancer, and San Fu Biotech, a subsidiary of San Fu Chemical Co. , ltd (4755.TW), have entered into a license agreement for the development and commercialization of RGI-2001, a drug for the prophylaxis of Acute Graft-versus-Host Disease (aGvHD), in major Asian countries

RGI-2001 has a novel mechanism to improve existing therapies and is potentially a first-in-class small molecule drug candidate targeting the prevention of aGvHD, a life-threatening complication arising from allogeneic hematopoietic stem cell transplantation (HSCT). GvHD is a systemic disorder that occurs when the transplant's immune cells recognize the host as foreign and attack the recipient's body cells or organs. This leads to skin rashes, liver problems, abdominal pain or cramps, diarrhea and an increased risk of infection. Patients undergoing allogeneic HSCT are at increased risk of developing aGvHD, which is associated with significant morbidity and mortality.

Under the terms of the agreement, REGiMMUNE and SFB will work closely to accelerate the development of RGI-2001 in major Asian countries and conduct clinical trials to test the drug's efficacy in aGvHD. Both parties plan to jointly submit an investigational new medicinal product (IND) application in Taiwan for the prophylaxis of aGvHD before the end of 2023. SFB will make REGiMMUNE payments for development milestones and will pay royalties on net profits after the successful commercialization of RGI-2001. SFB also retains first negotiation rights for the development and commercialization of RGI-2001 for new indications in the treaty territories.

REGiMMUNE's RGI-2001 was designated an orphan drug for GvHD by the US FDA in 2012 and has completed Phase II clinical trials for the targeted prophylaxis of aGvHD in the US. Efficacy and safety results were positive. In addition, RGI-2001 has been selected for an oral presentation at the American Society of Hematology (ASH) Annual Meeting in December 2022 and submission of Phase III IND data to the FDA is scheduled for Q4 2023.

Kenzo Kosuda , Chief Executive Officer and President, REGiMMUNE Limited said , “ This agreement underscores our focus and commitment to improving existing therapies for aGvHD prevention and treatment. The rapidly increasing number of patients with GvHD in Asia creates a high unmet need for more effective therapies. "

“We are pleased to be collaborating with SFB and San Fu Chemical Group , which has a long history of success in Taiwan. The group's rich biomedical resources, expertise and innovative strategy make San Fu a strong commercial partner for REGiMMUNE in Asia. Together we look forward to advancing the development of RGI-2001 in this important market.”

Simon HH Wu, Chairman of SFB & San Fu Chemical Group, said: “We are very excited to add RGI-2001 to our growing portfolio of innovative therapeutic compounds. This strengthens our pipeline in autoimmune disorders and is in line with our long-term research and development strategy. RGI-2001 has achieved promising results in Phase II trials in the US, and we look forward to collaborating with REGiMMUNE to deliver therapies that improve the lives of patients.”

 

Source:businesswire.com

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