The intended merger will create a pan-global Treg specialist to use multiple modalities to target Tregs for a number of indications.

Taipei, TAIWAN, and Paris, FRANCE, October 18, 2024 – REGiMMUNE, the regulatory T cell  targeting drugs for immunotherapy and Kiji Therapeutics, the specialist in Induced Pluripotent Stem Cells-Mesenchymal Stem Cells (IPSC-MSC) engineered cell therapies for inflammatory diseases, today announce an intention to merge both companies. This merger will create the Treg specialist REGiMMUNE/Kiji TX. The merger will be subject to customary conditions and full final due diligence by both parties.

The creation of the merged new company will combine the complimentary portfolio of platforms and therapies to create an international Treg biotech, and the leading company globally in modulating Treg function. Both companies have been focused on addressing unmet medical needs by the modulation of the Treg function. REGiMMUNE has been able to regulate the role of the Treg by using a molecule enhancer to increase Treg function, and monoclonal antibodies (depleter; inhibitor) to reduce the function of, or eliminate Tregs. Kiji can add an advanced, next generation multigene engineered stem cell therapy IL10 enhancer to increase Treg anti-autoimmune function.

The combination of these technologies will create an international specialist in Treg modulation and will focus on immune-oncology and autoimmunity. It will combine three diverse platforms, based on small molecules, monoclonal antibodies and cell and gene therapy. This will give REGiMMUNE/Kiji TX the ability to augment or reduce Treg function in vivo by downregulating Tregs in immune-oncology and upregulating Tregs in autoimmunity.

Commercially, REGiMMUNE/Kiji TX will prepare for an IPO with a listing in the Emerging Stock Market in Taiwan. Therapeutically, REGiMMUNE/Kiji TX will now initially focus its multiple target pipeline on 4 therapies. It will establish proof of concept with gene engineered mesenchymal stem cells (KJ01) in graft-versus-host disease (GvHD), and prepare for clinical entry in the second half of 2025, develop its iPSC platform (KJ02) for Inflammatory Bowel Disease (IBD), Psoriasis and CNS disorders, define clinical readiness with a Treg depleting/inhibiting monoclonal antibody (RGI6004) and advance clinical development with the launch of a phase III clinical trial with a clinical stage small molecule Treg enhancer targeting GvHD (RG2001). This will be developed for potential partnering activities.

The companies were brought together in discussions by the main REGiMMUNE shareholder, DCI Partner Co., Ltd. With high level executives based in Taiwan, Japan, Europe and the US, REGiMMUNE/Kiji TX will provide a global bridge for cell and gene therapy (CGT) development, and take advantage of the strong and growing interest in Southeast Asia, and specifically Taiwan for CGT.

The companies will be led by a highly experienced senior management team, with Miguel Forte as CEO and Kenzo Kosuda as co-CEO. Miguel Forte will contribute his extensive experience and network as the current President of leading global CGT association, the International Society for Cell & Gene Therapy (ISCT) and Alliance for Regenerative Medicine (ARM) board and executive committee member. Kenzo Kosuda brings extensive financial and management expertise together with East Asia experience. Tony Ting will be chief scientific officer, Ping Chung will be chief technology officer, TsungYen Wu will be chief business officer and Steve Yang will be chief operating officer.

“Tregs have proved themselves to be a leading promising modality in the cell and gene therapy field, both therapeutically and commercially. As a result of this potential, we have collectively created a global Treg specialist super-company to realize this potential,” said Miguel Forte, CEO, Kiji TX. “We will also be able to combine several fields, including small molecule, CGT and monoclonal antibodies to use Tregs to their full potential. These approaches are off-the-shelf and allogeneic, with a competitive advantage over autologous or patient matched Treg approaches currently in development in the sector. The new company now has a variety of options, including an IPO by mid-2025 in the Taiwan Stock Exchange. This will enable REGiMMUNE/Kiji TX to develop our multiple therapeutic pipeline inhouse, as well as partnering for co-development or out-licensing.”

“Modulating Treg function in both directions has significant potential in a variety of conditions with major commercial benefits. Creating the new Treg specialist REGiMMUNE/Kiji TX will result in a company that will have the resources to achieve this potential. With a planned IPO in 2025, we will be able to combine leading modalities to develop therapies for conditions involving significant numbers of patients globally,” said Kenzo Kosuda, CEO, REGiMMUNE. “The global reach of the company and experience of the senior management also enables us to explore development across the globe to match the therapeutic potential and size of the market that is open to us.”

Ends

 

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. REGiMMUNE is based on Taiwan.

About Kiji Therapeutics

Kiji Therapeutics is a company founded by EU Biotech VC AdBio Partners specializing in next generation IPSC-MSC engineered cell therapy for the treatment of a broad range of inflammatory diseases. Kiji TX is developing superior potency multi-gene engineered stem cell therapies (GePS). Kiji TX has the first-in-industry multi-gene engineered iMSC. Initial pre-clinical data demonstrates an over 70 percent improvement in selected targeting and augmented efficacy. It is achieving this through the induction of Tregs and Regulatory B cell (Bregs), with an innate immune system control. It is also developing allogeneic, off-the-shelf 3D manufactured, iPSC derived stem cells, gene engineered for targeted and potent therapeutic delivery. The initial targets are significant unmet medical needs with significant market potential in autoimmune diseases, including aGvHD, IBD and Psoriasis. Kiji TX’s lead product KJ01 is currently at IND-enabling stage for aGvHD. Kiji TX is based in France and Spain.

For more information please contact:

Neil Hunter
Hunter PR
neiljameshunter@gmail.com
+44 7821 255568

 

Corporate Contact

Miranda Yu
Investor Relations Manager
REGiMMUNE Ltd
+886 2 2555 3377 #511
miranday@regimmune.com

TsungYen Wu
CBO
Kiji Therapeutics SAS
yen@kiji-tx.com

 

 

REGiMMUNE Kiji Therapeutics 宣布合併意向

合併後將打造世界級台日歐美 Treg 專業生技公司,利用多種Treg技術平台開發多項免疫疾病與癌症療法

台灣台北與法國巴黎,2024 10 18 專注於免疫療法的調節性 T 細胞 (regulatory T cell, Treg) 開發商 REGiMMUNE 與專精於治療發炎性疾病的 iPSC-MSC (induced pluripotent stem cells-mesenchymal stem cells) 基因工程細胞療法專家 Kiji Therapeutics,今天宣布雙方的合併意向。此次合併將創建一個專注於 Treg 的全球性生物科技公司,該合併仍需雙方完成盡職調查及合約簽署。

雙方公司皆致力於通過調控 Treg 功能解決臨床未滿足的醫療需求,此次合併將結合雙方互補的技術平台與產品線,建立全球領先的 Treg 功能調控公司。REGiMMUNE的小分子藥物能活化並擴增 Treg ,另外單株抗體 (如 ADC、ADCC、抑制劑) 則能減少或消除 Treg 的功能。Kiji 則擁有先進的多基因工程幹細胞療法技術平台,開發能增強 Treg 抗自體免疫功能的IL-10 增強劑。

雙方技術結合後,REGiMMUNE/Kiji TX 將成為 Treg 調控領域的國際專家,專注於癌症免疫療法和自體免疫疾病。該公司將結合基於小分子、單株抗體和細胞基因療法的三大平台,這使得 REGiMMUNE/Kiji TX 能夠在體內通過負面調節 Treg 來對抗腫瘤,或通過正面調控 Treg 來治療自體免疫疾病。

在商業方面,REGiMMUNE/Kiji TX 正準備邁向台灣的興櫃市場;在產品方面,REGiMMUNE/Kiji TX 將首先聚焦於4個產品的開發。公司將使用基因工程間質幹細胞 (KJ01) 在移植物抗宿主病 (GvHD) 中進行概念驗證,並準備於 2025 年下半年進入臨床。同時,公司將開發 iPSC 平台 (KJ02) 用於治療發炎性腸道疾病 (inflammatory bowel disease, IBD) 、乾癬 (Psoriasis) 及中樞神經系統疾病 (CNS),並推進負面調節 Treg 單株抗體 (RGI6004) 的臨床準備。公司還將啟動一項針對 GvHD 的小分子 Treg 增強劑 (RG2001) 的 3 期臨床試驗,並尋求潛在的合作夥伴。

此次合併由 REGiMMUNE 的主要股東 DCI 合夥株式會社促成。REGiMMUNE/Kiji TX 的管理層將分布於台灣、日本、歐洲和美國,運用台灣及東南亞對細胞及基因治療 (Cell and Gene Therapies, CGT) 產品逐漸成熟的產業生態,為CGT產品開發提供全球研發及商業化橋樑。

合併後的公司將由經驗豐富的經營管理團隊領導營運,Miguel Forte 博士將擔任執行長,小須田建三將擔任聯合執行長。Miguel Forte 博士將帶來他在國際細胞與基因治療協會 (International Society for Cell & Gene Therapy, ISCT) 和再生醫療聯盟 (Alliance for Regenerative Medicine, ARM) 董事會中的經驗與人脈;小須田建三則將提供其在東亞地區豐富的財務和管理經驗。Tony Ting 博士將擔任科學長,鍾平宇博士擔任技術長,吳宗諺博士擔任商務長,楊思聖博士擔任營運長。

Miguel 表示:「當今Treg臨床治療以及商業發展已再再證明Treg 就會是CGT 領域的下一個當紅主導產業,因此,我們聯合建立了一家全球性的 Treg 專業公司,實現我們的潛力。我們將結合多個技術平台,包括小分子、CGT 和單株抗體,充分發揮 Treg 的優勢,這些方法比現成的同種異體方法更具有競爭優勢,抑或是比該領域目前正在開發的自體或患者匹配的 Treg 方法更具有競爭優勢。新公司將有多種選擇,包括於 2025 年中期在台灣的興櫃市場掛牌,這將促進 REGiMMUNE/Kiji TX 內部開發多種醫療產品線,並且全球海外合作共同開發以及全球向外授權。」

小須田建三補充道:「雙向調節 Treg 功能在多種疾病中具有巨大的潛力,也帶來了重大的商業價值。共同建立 的公司將擁有實現這商業價值的資源,並計劃於 2025 年邁向資本市場,開發能覆蓋全球眾多患者的療法。這家未來合併公司的高階管理層擁有全球影響力與經驗也將加速我們全球的發展,以匹配全球開放市場的治療潛力和規模。」

本文結束

 

關於瑞格國際生技

瑞格是一家總部設於台灣,專注於自體免疫疾病與癌症的公司,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Kiji Therapeutics

Kiji Therapeutics 是一家總部設於法國及西班牙,專注於新一代 iPSC-MSC 基因工程細胞療法的公司,旨在治療各種發炎性疾病。Kiji 正在開發高效多基因工程幹細胞療法 (GePS) ,並擁有業界首個多基因工程 iMSC,通過調控 Tregs 和 Bregs 並控制先天免疫系統。此外,Kiji 還開發了同種異體、off-the-shelf (立即可用) 的 3D 製造 iPSC 衍生幹細胞,這些幹細胞經過基因工程設計,可提供強效且有針對性的治療,其初步目標是解決自體免疫疾病中的重大未滿足醫療需求。

 

媒體連絡人:

瑞格國際生技股份有限公司
余明穎 (Miranda Yu)
投資人關係經理
+886 2 2555 3377 #511
miranday@regimmune.com

Kiji Therapeutics
吳宗諺 (TsungYen Wu)
商務長
yen@kiji-tx.com