PolyU collaborates with Axis Therapeutics to establish joint laboratory for immunotherapy

The Hong Kong Polytechnic University (PolyU) has entered into a formal collaboration with Axis Therapeutics (Axis) to foster cancer immunotherapy research and development, with the aim of improving cancer treatment for patients in Hong Kong. This collaboration will facilitate clinical trials of new T-cell receptor therapy using the newly established clinical Current Good Manufacturing Practice (cGMP) facility at PolyU, which is compliant with the GMP Guide for the Advanced Therapy Products (ATPs), and the development of at least 30 new targeting agents against novel T-cell targets in cancer immunotherapy.

An agreement signing ceremony for the establishment of the PolyU-Axis Therapeutics Joint Laboratory for Immunotherapy was held on 18 April. Witnessed by Prof. Wing-tak WONG, PolyU’s Deputy President and Provost; Mr Yonghui WANG, Chairman/President of Xiangxue Pharmaceutical Co Ltd (XPH) and President of Axis; Mr Kejian ZHANG, Chairman of the Strategic Development Committee of XLifeSc; and Dr Johnson Yiu Nam LAU, co-founder of Axis and Adjunct Professor of the Department of Applied Biology and Chemical Technology of PolyU, the agreement was signed by Prof. Larry Ming Cheung CHOW, Head of the Department of Applied Biology and Chemical Technology; and Dr Lun ZENG, CEO of Axis and CEO of XLifeSc.

Prof. Wing-tak Wong said that this collaboration would strengthen PolyU’s ongoing efforts in conducting cutting-edge research in life science, especially in the area of translational medicine in cell therapy for treating various diseases including cancers, making contribution to the development of the Greater Bay Area into an innovation hub for cell therapy. Over the years, PolyU researchers have been engaged in the development of three new drugs that have obtained the status of Investigational New Drug (IND) approved by the US Food and Drug Administration (FDA) for clinical trials, all involved in cancer drug treatment. Both small molecules like flavonoids and biologics (arginase enzymes) have been developed at PolyU by the State Key Laboratory of Chemical Biology and Drug Discovery and the Department of Applied Biology and Chemical Technology.

Immunotherapy and cell therapy are two of the most important discoveries for treating cancer of the past decade. The 2018 Nobel Prize in Physiology or Medicine was awarded to the discovery of the importance in cancer treatment of T-lymphocyte proteins CTLA-4 and PD-1. This opened a new area of “immune checkpoint therapy” whereby the cancer patient’s own immune system can be reactivated to kill the cancer cells. Another type of immunotherapy is the “adoptive cell therapy” where cancer patient’s own T-cells are collected, genetically modified to give them new function to kill cancers and then expanded in large numbers before being administered back to patients. One example of this therapy is T-cell receptor-engineered T cells (TCR-T), where XPH and its subsidiaries XLifeSc and Axis are the global leaders in this field.

Mr Yonghui Wang emphasised that XPH had been committed to the cell therapy programme since 2012. In 2018, Axis entered into an MOU with PolyU to bring cell therapy to cancer patients in Hong Kong. Axis/XLifeSc focuses on utilising the T-cell adoptive immunotherapy technology (TAEST technology) to treat cancers and has engaged in the research into and development of a new generation of anti-tumor TCR-T with a high specificity and affinity for a wide range of malignant solid tumors. Importantly, Axis already has two products with IND approvals in China for soft tissue sarcoma and primary liver cancer. The collaboration with PolyU will further enable Axis to conduct clinical trials in Hong Kong and benefits patients in the city. Moving forward, Axis will collaborate with PolyU in the development of up to 30 further targeting biologics, which could be adapted into novel cell therapy of the future.

With the funding support from the University Grants Committee, PolyU established a new clinical cGMP facility on campus which is compliant with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)’s GMP Guide for the clinical research and development in the ATPs. This cGMP facility will use an isolator for aseptic handling of human stem cells or immune cells for regenerative medicine or immunotherapy clinical trials. It will be also equipped with a training production facility to provide professional training. PolyU researchers will work closely with Axis to unveil new tumour targeting biologics, including TCR-like antibodies, and to explore and develop them for cancer treatment based on cell therapy approach.

The Hong Kong Polytechnic University (PolyU)

The Hong Kong Polytechnic University (PolyU) aspires to be an innovative world-class university with a strong sense of social responsibility, driven by its motto, “To learn and to apply, for the benefit of mankind”. The University provides the best holistic education to nurture socially responsible “leaders of tomorrow” who possess a strong sense of national identity and a global perspective and pursues impactful innovation and interdisciplinary research to address the world’s most pressing challenges. A robust culture of knowledge transfer and entrepreneurship is a cornerstone of the University, ensuring PolyU’s technologies are transformed into practical real-world applications. The University's unwavering commitment to excellence has earned it international recognition, with PolyU consistently ranking among the top 100 universities worldwide. Based on this solid foundation, the University will continue to make positive contributions in collaboration with its strategic partners for the betterment of Hong Kong, the Nation, and the world.

For more information, please visit: www.polyu.edu.hk

Guangzhou Xiangxue Pharmaceutical Co. Ltd (XPH) and Axis Therapeutics (Axis)

Founded in 1997 and located in Guangzhou Science City, Guangzhou Economic and Technical Development District, XPH is a high-tech enterprise integrating manufacturing, operation and R&D of products including pharmaceuticals, biological medicine, functional food, Chinese medicines and medical devices. XPH is recognised as one of the pharmaceutical enterprises with most development potential in China and has been listed on the Shenzhen Stock Exchange since 2010 (stock code: 300147).

XLifeSc, a subsidiary of Xiangxue Pharmaceutical, specializes in high affinity specific T cell adoptive immunotherapy technology (TAEST technology) for researching new generation anti-tumor high specificity and high affinity TCR-T cell products for malignant solid tumors. With a rich pipeline of targets in development and two IND clinical approvals in China and the United States, XLifeSc is positioned as the leading TCR-T cell therapy enterprise in China. In 2018, XLifeSc established Axis Therapeutics in Hong Kong to serve as a platform for overseas expansion with rights for all products and a focus on Hong Kong and international opportunities.

For more information, please visit www.xphcn.com and http://www.xlifesc.com/m/about/about.aspx

Media contacts

Miss Edith Ma
Executive Officer      

Department of Applied Biology and Chemical Technology
Tel: +852 3400 8606

Email: ho-yin-edith.ma@polyu.edu.hk

Ms Jess Fung

Manager, Public Affairs

Communications and Public Affairs Office

Tel: +852 2766 5197

Email: sf-jess.fung@polyu.edu.hk

理大與免疫鍵有限公司合作成立免疫治療聯合實驗室

香港理工大學（理大）與免疫鍵有限公司（Axis）正式合作，共同促進癌症免疫治療研發，改善香港癌症患者的治療成效。是次合作將利用理大新建立、符合現行藥品生產管理規範（cGMP）的先進療法製品（ATP）實驗室和設施進行多種新型「T細胞受體工程T細胞」（TCR-T細胞）療法的臨床試驗。雙方亦將合作開發至少 30 種針對癌症免疫治療中新型 T 細胞標靶的新型抗體等生物製劑。

理大與免疫鍵合作成立「香港理工大學 - 免疫鍵有限公司免疫治療聯合實驗室」的協議簽署儀式於4月18日舉行。 在理大常務及學務副校長黃永德教授、免疫鍵有限公司董事長及香雪製藥董事長王永輝先生、香雪生命科學戰略委員會主任張克堅先生、免疫鍵有限公司聯合創始人及理大應用生物及化學科技學系客座教授劉耀南醫生的見證下，由理大應用生物及化學科技學系系主任周銘祥教授，以及免疫鍵有限公司執行長兼香雪生命科學執行長曾侖醫生代表簽署。

黃永德教授致辭時表示，是次合作將加強理大在生命科學領域的前沿研究，特別是細胞療法轉化醫學方面的努力，以治療包括癌症在內的多種疾病，為促進大灣區發展成為細胞治療創新中心作出貢獻。多年來，理大研究人員已參與三種取得美國食品及藥物管理局（FDA）批准進行臨床試驗（IND）的癌症治療新藥物研究工作。藥物中的黃酮類化合物和生物製劑（精氨酸酶）等小分子是由理大化學生物學及藥物研發國家重點實驗室和應用生物與化學科技學系開發。

免疫療法和細胞療法是過去十年在治療癌症方面的兩大重要發現。2018年諾貝爾生理學或醫學獎得獎項目便是突破性發現 T 淋巴細胞蛋白CTLA-4 和 PD-1在癌症治療中的重要性。這開啟了「免疫檢查點療法」的新領域，透過此療法可重新激活癌症患者自身免疫系統以殺死癌細胞。另一種免疫療法是「過繼性細胞療法」，透過收集癌症患者自身的T細胞進行基因改造，賦予它們殺死癌症的新功能，然後在實驗室內進行大量擴增，再回輸予病人。此療法的其一例子是TCR-T療法，而香雪和子公司香雪生命科學及免疫鍵是此領域的全球領導者之一。

王永輝先生致辭時表示，香雪製藥有限公司自2012年起致力於細胞治療計劃，2018年在港成立免疫鍵，並與理大簽署合作備忘錄，期望為香港癌症患者提供細胞療法。免疫鍵專注利用T細胞過繼免疫治療技術（TAEST技術）來治療癌症，致力於對多種惡性實體腫瘤具高特異性和親和力的新一代抗腫瘤TCR-T研發。目前，免疫鍵有兩款產品於中國獲得臨床試驗批准，分別用於軟組織肉瘤和原發性肝癌的治療。是次與理大的正式合作將進一步加速免疫鍵在香港進行臨床試驗，讓更多本地病人受惠，亦將與理大合作開發多達30種標靶的抗體生物製劑，應用於未來的新型細胞療法。

在大學教育資助委員會資助下，理大於校園設立cGMP設施，其符合國際醫藥品稽查協約組織（PIC/S）就先進療法製品臨床研究和開發指南。該設施將使用隔離器對人類幹細胞或免疫細胞進行無菌處理，用於再生醫學或免疫療法的臨床試驗，並配備專業培訓設施。理大研究人員將與免疫鍵合作，研發更多新型腫瘤標靶生物製劑，包括TCR樣抗體，研究和開發它們用於基於細胞治療方法的癌症治療。

有關香港理工大學

香港理工大學（理大）秉承校訓「開物成務 勵學利民」的精神，矢志成為一所創新型世界一流大學，並以肩負社會重任為宗旨。理大為學生提供優質的全面教育，致力培育具良好國民意識、全球視野與社會責任感的「明日領袖」；同時推動具影響力的創新與跨學科研究，以應對全球最迫切的挑戰。知識轉移與創業文化亦是理大的基石，大學著重研以致用——將所研發的科技轉化為實際應用。理大追求卓越，努力不懈，深得國際認可，持續位居全球百強學府之列。理大將繼續以其雄厚根基，與各界策略夥伴合作，力求造福香港、國家乃至全球。

更多資料，請瀏覽：www.polyu.edu.hk。

有關廣州香雪製藥有限公司、免疫鍵有限公司

廣州市香雪製藥股份有限公司（香雪製藥）成立於1997年，位於廣州黃埔區科學城，擁有自主智慧財產權、自主品牌、自主創新能力的中藥現代化領軍企業和國家級高新技術企業，在中藥資源、智慧中醫、高效能新藥創制、中藥先進製造、生命科學研究、醫療器械等領域的大健康產業形成了全產業鏈集成創新體系。被業界認為是最具發展潛力的製藥企業之一，中國醫藥行業百強企業。香雪製藥於2010年在中國深圳證券交易所首次公開發行股票（IPO）掛牌上市（股票代碼：300147）。

香雪生命科學技術（廣東）有限公司（香雪生命科學XLifeSc）是香雪製藥的子公司，主要利用高親和性特異性T細胞過繼免疫治療技術（TAEST技術），開展針對惡性腫瘤實體瘤進行新一代抗腫瘤高強特異性和高親和性T細胞免疫治療TCR-T細胞產品的研究，香雪生命科學靶點豐富的在研管線，在中國和美國擁有兩個IND臨床批件，是中國TCRT細胞治療頭部企業。 2018年，香雪生命科學在香港成立子公司「免疫鍵有限公司」，作為海外拓展平台，擁有所有產品的海外權利，並專注於香港和國際機會。

更多資料，請瀏覽﹕ www.xphcn.com 及 http://www.xlifesc.com/m/about/about.aspx。

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馬浩然女士
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電話﹕+852 3400 8606
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