Taipei, March 29, 2023 – 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.”

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 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.

 

Corporate Contact:

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

 

瑞格國際生技授權三福生技於主要亞洲國家開發及商業化RGI-2001

2023年3月29日，台北 – 專注於自體免疫疾病與癌症，開發創新免疫療法之生技公司 – 瑞格國際生技今日宣佈與台灣三福化工集團所屬之三福生技簽署授權協議。三福生技將取得RGI-2001亞洲區主要國家之開發和商業化權利，聚焦於急性移植物抗宿主疾病(aGvHD)之預防。

RGI-2001以全新的藥物機轉改善現有治療方式，有濳力成為急性移植物抗宿主疾病預防之臨床首創機制(First-in-Class)小分子新藥。移植物抗宿主疾病是異體造血幹細胞移植引起排斥反應的致命併發症，係因捐贈者的免疫細胞將受贈病患的細胞或器官視為外來物，並加以攻擊，導致諸如皮膚疹、肝臟問題、腹痛或痙攣、腹瀉和增加感染風險等全身性症狀。病患接受異體造血幹細胞移植後，急性GvHD之發病與死亡風險俱增， 據臨床資料顯示，在人類白血球抗原(Human Leukocyte Antigen)配對之親屬及非親屬捐贈的異體造血幹細胞移植案例中，儘管已使用預防性之免疫抑制劑，仍有20% ~ 40%病患產生急性GvHD，嚴重者甚至導致非復發性死亡。

根據授權協議條款，瑞格國際生技和三福生技將密切合作，加速RGI-2001在亞洲主要國家的發展，執行臨床試驗探究對急性GvHD預防之療效。雙方合作擬於2023年底前，先向台灣衛福部申請新藥臨床試驗審查，展開預防急性GvHD之臨床試驗。三福生技將支付里程金予瑞格國際生技，並在RGI-2001成功商業化後，依獲利金額另支付權利金。對於RGI-2001未來新開發之適應症，三福生技在授權區域內也保有開發及商業化之優先議約權。

RGI-2001於2012年取得美國食品藥物管理局(FDA) 移植物抗宿主疾病孤兒藥資格認定，已在美國完成預防急性GvHD第二期臨床試驗，療效與安全性結果均屬正面，並在2022年12月獲選於美國血液學會(ASH)年會口頭發表臨床試驗成果，規劃於2023年第4季向美國FDA申請第三期人體臨床試驗審查(IND)。

「這項協議凸顯我們改善急性GvHD預防與治療方式的關注與承諾。亞洲主要國家GvHD病患人數快速成長，亟需更有效的預防與治療方式，填補未被滿足的醫療需求。」瑞格董事長暨執行長小須田建三先生進一步表示：「我們很高興在台灣能與有著悠久歷史的三福集團及三福生技合作。對於瑞格而言，三福生技擁有豐厚的生技醫療資源、專業知識和紮實的創新策略，實為亞洲市場堅強的商業夥伴。我們期待在這個重要市場中加快RGI-2001的發展進程。」

三福生技董事長巫信弘強調：「我們很高興能將RGI-2001加入到公司日益增長的創新治療藥物中，強化自體免疫產品組合，符合我們的長期研發策略。RGI-2001美國第二期臨床試驗數據相當優異，我們期待與瑞格攜手合作，在亞洲提供改善血癌病患急性GvHD的預防與治療方式。」

本文結束

 

關於RGI-2001

RGI-2001係為α-半乳糖神經醯胺(α-GalCer)之脂質體制劑。α-GalCer 為在抗原呈遞細胞(Antigen Presenting Cells)與恆定自然殺手T細胞(iNKT)上表達CD1d之配體。脂質體α-GalCer提升耐受性免疫連鎖效應，活化並擴增調節性T細胞。RGI-2001為瑞格國際生技主要之候選藥物，聚焦急性移植物抗宿主疾病(aGvHD) 之預防，將規劃開展第三期臨床試驗。

關於瑞格國際生技

瑞格係為專注於自體免疫疾病與癌症，運用調控調節性T細胞(Tregs)，開發創新免疫療法之臨床生技公司。瑞格構建之全新候選藥物組合係藉由調控調節性T細胞活性，用於治療免疫疾病及癌症。

關於三福生技

三福生技為三福化工全資子公司，以開發臨床首創機制(First-in-Class)新藥，解決未被滿足之醫療需求，如癌症腫瘤、自體免疫及眼睛病變等三大疾病領域，嘉惠全球廣大患者。

 

媒體聯絡人:

許育誠 (Charlie Hsu)
財務長
瑞格國際生技股份有限公司
+886 2 2555 3377 #511
charlieh@regimmune.com