San Fu Biotech In-Licenses RGI-2001 for Development and Commercialization in Major Asian Countries from REGiMMUNE

Taipei, March 29, 2023 – San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd. (4755.TW), has entered into a licensing agreement with REGiMMUNE Corporation (REG) to develop and commercialize RGI-2001 for the prophylaxis of acute Graft-versus-host disease (aGvHD) in major Asian countries.

RGI-2001, a first-in-class small molecule drug candidate developed to enhance existing treatments of the prophylaxis of acute GvHD, a severe complication arising from allogeneic hematopoietic stem cell transplantation (allo-HSCT). Graft-versus-host disease (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. This can result in various symptoms such as skin rash, liver damage, abdominal discomfort, diarrhea, and an elevated risk of infections. Despite the implementation of preventive immunosuppressive therapy (typically, steroids), clinically noteworthy instances of acute GvHD arise in 20%-40% of human leukocyte antigens (HLA)-related and 60%-80% HLA-unrelated allogeneic HSCT. Severe cases contribute significantly to non-relapse mortality.

Under the agreement, REG and SFB will collaborate closely to facilitate the development of RGI-2001 by conducting clinical trials to assess its efficacy in tackling aGvHD among Asian patients. Both parties also planned to initiate a multi-center, multi-national Phase III clinical trial in the USA, Taiwan, and most likely, South Korea, in 2024, with the goal to apply NDAs simultaneously in these regions.

SFB will remit to REG with the milestone payments and royalties upon successful commercialization of RGI-2001. In addition, SFB retains the first rights of refusal to develop and commercialize RGI-2001 for new indications in the authorized territories.

REG’s RGI-2001 was awarded the “Orphan Drug Designation” status by the US FDA in 2012 and its phase II clinical trial targeting at the prophylaxis of aGvHD has been completed in the US. The efficacy and safety results demonstrated to be positive. As a result, RGI-2001 was selected for an oral presentation at the American Society of Hematology (ASH) annual meeting in December 2022 and planned to submit the phase III IND to US FDA in 2024.

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.”

Kenzo Kosuda, Chief Executive Officer and President, REGiMMUNE Corporation, 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.”

Ends
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 III planning for the prophylaxis of acute graft-versus-host disease (aGVHD).

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 oncology, immunology and ophthalmology, for benefiting patients around the world.

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.

Corporate Contact:

Daniel C.H. Cheng, Ph.D.
President
San Fu Biotech CO., LTD.
+886 2 2542 6789 #500
dccheng@sanfubio.com.tw

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First-in-Class novel drug in preclinical stage

What is a retinal disease?

The retina consists of millions of photoreceptor cells and other nerve cells responsible for receiving and organizing visual signals.1 Population-based studies show retinal diseases prevalence ranging from 5.35% to 21.02% in individuals aged 40 and above.2 Retinal diseases are the primary cause of irreversible blindness in developed countries and the second leading cause of blindness in developing countries, following cataracts.

Unmet Medical Needs

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Preclinical Stage

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A novel drug candidate potential effective and patient-friendly treat the retinal diseases, preventing blindness.

  1. Richard H. Masland. Neuron. 2012; 76(2): 266-280.
  2. Matthew J Burton et al. Lancet Glob Health. 2021; 9(4): e489-e551.
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The action of balancing the immune system.

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