亚太药物研发领袖峰会 暨 精准肿瘤免疫与细胞基因治疗峰会2020

精准肿瘤免疫治疗研发 议程和讨论热点:
主旨演讲：Development and Commercialization of Globally Innovative Medicines in China
-- The benefits and challenges of developing globally innovative medicines in China
-- The benefits and challenges of having multiple global partners
-- What the future will bring to the pharmaceutical industry in China
Kerry Blanchard 博士, 首席执行官, 云顶新耀 [ Dr. Kerry L. Blanchard, Chief Executive Officer, Everest Medicines ]

主旨演讲：Exploration of Epigenetic Modulation as a New Anti-cancer Treatment
-- Relapse, metastasis and drug resistance still a great challenge facing in todays therapeutic treatment
-- Epigenetic aberrations in cancer development is a key process to target on the above-mentioned challenges
-- Scientific effort to develop a novel epigenetic modulator as a new cancer treatment from blood cancer to solid tumors
鲁先平 博士, 董事长兼首席执行官, 深圳微芯生物 [ Dr. Xian-Ping Lu, Chairman & Chief Executive Officer, Chipscreen Biosciences ]

主旨演讲：Future Cancer Immunotherapy Revolution
-- Immunotherapy Revolution: The discovery and development of immune checkpoint inhibitors has revolutionized the cancer treatment
-- Current Challenges in immunotherapy: biomarker identification, efficacy, and drug resistance
-- Next-Generation Immuno-oncology agents: New approaches to remove obstacles to immune function
秦续科 博士, 首席医学官, 科望医药 [ Dr. Steve Chin, Chief Medical Officer, Elpiscience Biopharma ]

主旨演讲：Innovative Approach to Develop First-in-class drugs Globally with Precision Medicine
-- Novel and proprietary biomarker platform to advance drug development, including re-evaluating medicines that have failed in general patient populations by stratifying the responders for the original indication
-- Identifying biomarkers correlated with patients' responses to drug candidates retrospectively, Denovo enables the design and execution of follow-on clinical trials in targeted patient populations while optimizing efficacy, safety and tolerability
-- Denovo currently has five late stage drugs in its pipeline: DB102 for DLBCL and GBM, DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer’s Disease, and DB106 for acute myeloid leukemia (AML).
罗文 博士, 首席执行官兼首席科学官, 索元生物  [ Dr. Wen Luo, Chief Executive Officer & Chief Scientific Officer, Denovo BioPharma ]

主旨演讲：Advancing siRNA Therapeutics for Enhancing Antitumor Activity of Immune Checkpoint Inhibitor
Abstract: Using a proprietary and optimized polypeptide nanoparticle-based delivery technology, we have developed the novel anti-fibrosis and anti-cancer therapeutics with siRNAs targeting both TGFβ1 and Cox-2 simultaneously (STP705), resulting in human fibroblasts apoptosis. STP705 was initially used for local treatments for skin hypertrophic scar and non-melanoma skin cancer. STP707 (a systemic formulation of STP705) was further advanced for treatment of liver fibrosis and cholangiocarcinoma, both of these indications have received Orphan drug designations by US FDA. Using a mouse syngeneic model of hepatocellular carcinoma, we tested a therapeutic potential of antitumor activity with a combination of STP707 and PD-L1 mAb. After multiple IV administrations twice a week, both single agent of STP707 and the combination treatments resulted in strong antitumor activity, more potent than those treated with Sorafenib and PD-L1 alone. Those antitumor activity were further supported by significant increase of CD8+ and CD4+ T cell infiltrations into the tumor tissue. I will discuss the unique advantage of our Polypeptide Nanoparticle (PNP) technology platform for safe and efficient siRNA delivery, and our strategy for advancing multiple clinical studies ongoing in both USA and China.
陆阳 博士, 总裁兼首席执行官, 圣诺制药 [ Dr. Patrick Y. Lu, President & Chief Executive Officer, Sirnaomics ]

主旨演讲：Strategy and Technology Investment for Innovative Medicines
-- Innovative medicines in China: progresses and gaps
-- Lead identification technologies and structure-based drug design
-- Computer-Accelerate Rational Discovery (CARD) and Artificial Intelligence
Xiayang Qiu 博士, 创始人兼首席执行官, 齐鲁锐格 [ Dr. Xiayang Qiu, Founder and Chief Executive Officer, Qilu Regor Therapeutics ]

主旨演讲：Small Molecule, Big Impact: Building Global Leading Synthetic Lethality Product Pipeline
包骏 博士, 总裁兼首席执行官, 英派药业 [ Dr. Jun Bao, President and Chief Executive Officer, IMPACT Therapeutics ]

主旨演讲：Tumor Microenvironment and TGF-β pathway
郑彪 博士, 首席科学官, 劲方医药  [ Dr. Biao Zheng, Chief Scientific Officer, GenFleet Therapeutics ]

主旨演讲：Challenges and Opportunities of Global Bio-Therapeutic Industry: New time with great opportunity in different arenas
周新华 博士, 总裁兼首席科学官, 嘉和生物 [ Dr. Joe Zhou, President and Chief Scientist, Genor Biopharma, Visiting Professor, Peking University ]

小组讨论: 促进源于中国的创新 – 中国未来癌症免疫肿瘤药品开发及临床研究战略
Panel Discussion: Promoting China Innovation – Revolution in Future Cancer Immunotherapies in China:
Panelists:
李正卿 博士, 全球副总裁, 总经理, 默沙东研发 (中国) 有限公司, 默沙东实验室
-- Vice President and Head of MSD China R&D, Merck Research Laboratories
王莉 博士, 高级副总裁,药物发展和医学事务中心负责人, 礼来中国
-- Senior Vice President and Head of Lilly China Drug Development & Medical Affairs Center (LCDDMAC), Eli Lilly
顾娟红 女士, 副总裁, 研发创新中心总监, 肿瘤治疗与罕见病治疗总监, 法国益普生集团
-- Vice President, Head of R&D Innovation Hub, Therapeutic Area Oncology / Rare Diseases, IPSEN
金建军 博士, 临床开发总监, 诺华制药
-- Head of Clinical Development, Novartis, China
周辉 博士, 副总裁, 医学科学与战略肿瘤部, 信达生物制药集团
-- Vice President, Medical Science and Strategy Oncology, Innovent Bio
郭晓宁 博士, 副总裁，研发负责人兼首席医学官, 赛生医药
-- Vice President, Head of R&D and CMO, SciClone Pharmaceutical

小组讨论: 促进源于中国的创新 – 新药研发合作新模式
BD Panel Discussion: New Modalities Development Opportunities and Challenges

Panelists:
Kerry Blanchard 博士, 首席执行官, 云顶新耀
-- Chief Executive Officer, Everest Medicines
Jonathan Wang 博士，商务开发高级副总裁,, 再鼎医药
-- Senior Vice President, Head of Business Development, Zai Laboratories  
Blake Salisbury 博士, 商务开发高级副总裁，信达生物
-- Vice President, Business Development, Innovent Biologics
Alex Ye 博士, 商务开发高级副总裁, 阿诺医药
-- Vice President of Global Business Development, Adlai Nortye Bopharma

小组讨论: 促进源于中国的创新 R&D Innovation in China

Panelists:
尹鹤群 博士, 首席科学官, 齐鲁制药
-- Chief Scientific Officer, Qilu Pharma
万昭奎 博士, 创始人兼首席执行官, 凌科药业
-- Founder & Chief Executive Officer, Lynk Pharmaceuticals  
边锋 博士, 资深总监, 辉瑞亚洲创新中心
-- Senior Director & Asia Emerging Science Lead (Shanghai), Emerging Science & Innovation (ES&I), Pfizer Worldwide R&D, Pfizer  
党群 博士, 首席执行官, 石药集团上海翊石医药技术有限公司
-- Corporate Vice President, President, CEO, CSPC, CSPC Shanghai Research Institute, InnovStone Therapeutics

●  CAR-TCR细胞与基因治疗研发及创新峰会 议程和讨论热点:
** Tsinghua University [ 清华大学 ]
林欣 教授, 基础医学系系主任, 清华大学医学院 ( Professor and Chairman, School of Medicine, Department of Basic Medical Sciences, Tsinghua University )

主旨演讲：Engineering TCR-based Immunotherapy against Cancer and Viral Infection
-- Designing and applying TCR-T cell approaches for immunotherapy against viral infection
-- Developing a novel CAR, Synthetic TCR and Antigen Receptor (STAR), method for cancer immunotherapy
林欣 教授, 基础医学系系主任, 清华大学医学院 ( Professor and Chairman, School of Medicine, Department of Basic Medical Sciences, Tsinghua University )

主旨演讲：Developing AAV-based Gene Therapy Products in China, esp. from the Technical Development Front
肖溯 博士,  首席技术官,  武汉纽福斯生物科技有限公司 [ Dr. Su Xiao, Chief Technical Operation Officer, Neurophth Therapeutics ]
Alvin Luk 博士, 首席执行官,  武汉纽福斯生物科技有限公司 [ Dr. Alvin Luk, Chief Executive Officer, Neurophth Therapeutics ]

主旨演讲：Industrializing Cell & Gene Therapies: Managing Complexity Across the Ecosystem
刘必佐 先生, 首席执行官 兼 首席财务官, 西比曼生物科技集团 [ Mr. Tony Liu, Chief Executive Officer & Chief Financial Officer, Cellular Biomedicine Group ]

主旨演讲：Revolution of CAR-T Cell Therapies: Regulatory and Commercialization Considerations for Yescarta in China
王立群 博士, 首席执行官, 复星凯特生物科技有限公司 [ Dr. Richard Wang, Chief Executive Officer, Fosun Kite Biotechnology ]

主旨演讲：Precision TCR Redirected T Cell Immunity Treating Solid Tumor
-- The Evolution of TCR-T
-- XLifeSc 3rd Generation TCR-T
-- Case Studies of TCR-T Drug Treatment for Solid Tumors
李懿 博士, 总裁兼首席科学官, 广州市香雪生命科学中心 [ Dr. Yi Li, President and Chief Scientific Officer, Guangdong Xiangxue Life Sciences ]

主旨演讲：CAR T Process Development and in Process and Batch Releasing Assay Development
-- Developing a dependable and consistent CAR T process for a qualified CAR T products
-- Developing the in process control and batch releasing assays to assure the quality of CAR T product
蒋忻坡 博士,  高级总监, 方法分析/工艺验证/QC/QA, 南京传奇生物 [ Dr. Xinpo Jiang, Senior Director, Analytical/Process Validation/QC/QA, Legend Biotech ]

主旨演讲：Translating and Developing Novel Cell Therapy Product for Fighting against COVID-19
-- Emerging Infectious Disease such as SARS, COVID-19 is one of the biggest human threat
-- The mechanism of action of cell therapy to treat COVID-19
-- The development of MSC product from bench to clinic during the pandemic
-- The outcome of clinical study of using MSCs to treat patients with severe COVID-19
张宇 博士, 高级副总裁兼首席科学官, 中源协和 [ Dr. Yu Zhang, Senior Vice President and Chief Scientific Officer, VCANBIO Cell & Gene Engineering ]

主旨演讲：Development of Safe and Potent CD19 CAR-T Cell Therapy in China targeting Hematological Malignancies
Abstract: CD19-targeted chimeric antigen receptor-T (CAR-T) cells with CD28 or 4-1BB (28z CAR-T and BBz CAR-T) have shown great promise to treat relapsed or refractory (r/r) B cell non-Hodgkin’s lymphoma (B-NHL). However, parallel comparison of their clinical outcomes has never been reported. This study investigated their efficacy and adverse events in B-NHL therapy. Six patients with r/r B-NHL were initially enrolled and infused with 28z or BBz CAR-T cells at a dose of 0.75–5x105/kg. These CAR-T cells showed similar antitumor efficacies, with a complete response (CR) rate of 67% within 3 months. BBz CAR-T was well tolerated. However, severe cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred in the 28z CAR-T cohort, resulting in the termination of further evaluation of 28z CAR-T. Three more patients were enrolled to investigate BBz CAR-T cells in-depth at an escalated dose (1-106/kg). All cases achieved CR within 3 months, and only grade 1/2 adverse events occurred. This study suggests that 4-1BB is more beneficial for the clinical performance of CAR-T cells than CD28 in CD19-targeted B-NHL therapy, at least under our manufacturing process.
何霆 博士, 首席执行官, 北京艺妙神州医药科技有限公司 [ Dr. Ting He, Chief Executive Officer, ImmunoChina Pharmaceuticals ]

主旨演讲：Novel CAR-T Therapy for T Cell Malignancies
Abstract: CD7 is an attractive therapeutic target for T-lymphoblastic leukemia/lymphoma (T-ALL/LBL). CD19-CAR-T for the treatment of R/R B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin's lymphoma (B-NHL) has achieved great success, and therefore greatly promoted the exploration of CAR-T cell therapy to other targets and indications, including T-ALL/T-LBL.However, some big challenges have to be overcome for CD7-CAR-T therapy, including 1) potential contamination by abnormal T cells in CAR-T products; 2) life-threatening T cell hypoplasia; and 3) CAR-T cell fratricide due to CD7 expression on normal T cells.A first-in-class autologous CD7-CAR-T cells were developed by PersonGen and exhibited exciting clinical efficacy and safety in treating R/R T-ALL/LBL.
- Clinical significance of T-ALL/LBL
- Challenges for CD7-CAR-T R&D
- Clinical progress of PersonGen’s CD7-CAR-T
杨林 博士, 首席执行官, 博生吉医药科技（苏州）有限公司 [ Dr. Lin Yang, Founder and Chief Executive Officer, PersonGen BioTherapeutics ]

主旨演讲：Novel Proceeding about Targeting CD 30 CAR-T Therapy for Lymphoma
Abstract: CAR-T cells therapy has been demonstrated good tolerability and effects in patients with Hodgkin lymphoma (HL) and anaplastic large cell lymphomas (ALCL). However, most studies utilized the second-generation CARs with either CD28 or 4-1BB costimulatory domains resulting in unsatisfactory complete remission rate. Here, we designed a novel third-generation CAR against CD30 and investigated the efficacy and safety on CD30 positive relapsed or refractory lymphoma patients.  We found that the anti-CD30 CAR-T cells specifically homing to the tumor with powerful anti-tumor activity in the tumor xenografts. We then conducted a pilot study to evaluate the safety and feasibility of anti-CD30 CAR-T cells which were infused simultaneously in 14 patients with r/r HL and ALCL.  The third-generation anti-CD30 CAR-T cells had superior expansion and longer persistence, and the lentiviral copies could be detected after CAR-T infusion for half a year.  Of Thirteen patients (92.9%) were successes responded and ten patients (71.4%) achieved complete remission (CR) for 12 months and also four patients remained in CR longer than two years in the patients (4/5) followed over two years. Our results showed that CRS occurred in eleven patients but was mild, only one patient developed CRS over 3 grade, and other 10 patients developed grade 1 or 2 CRS who did not require anti-IL6 therapy. Thus, anti-CD30 CAR-T cells is safety and effective for treating relapsed/ refractory HL and ALCL patients.
张同存 教授, 董事长, 武汉波睿达生物科技有限公司, 院长, 武汉科技大学生命科学与健康学院[ Dr. Tony Zhang, Chairman, Wuhan Bio-Raid Biotechnology ]

主旨演讲：Precision Immunotherapy: Development BCMA-Targeted CAR T-Cell Therapy for R/R Multiple Myeloma
-- Global status of BCMA-targeted CAR-T cells
-- Current situation of bispecific CAR-T cells targeting BCMA
-- Characteristics of CT103A, IASO Bio-therapeutics’ BCMA-targeted CAR-T cell product
-- Preliminary clinical data of CT103A
汪文 博士, 首席医学官, 驯鹿医药 [ Dr. Wen (Maxwell) Wang, Chief Medical Officer, IASO Biotherapeutics ]

主旨演讲：Solid Tumor CAR-T Barriers and Solutions
-- Solid tumor quite different from hematologic malignancies
-- Tumor microenvironment
-- CAR-T design, traditional CAR, novel concept CAR, TCR-like
-- Therapy combination
王恩秀 博士, 首席执行官, 南京卡提医学科技有限公司 [ Dr. Enxiu Wang, Chief Executive Officer, Nanjing CART-MED ]

主旨演讲：Development of Next Generation Safe and Potent NKG2D CAR-T Cell Therapy and Next Generation CAR-T Cells
-- CAR-T development history
-- Safety and potent CART development background and cases show
-- Safety and potent KD-025 CAR-T Cell Therapy Progress
-- The case study of KAEDI next generation CAR-T Cells
代红久 博士, 首席执行官, 南京凯地生物科技有限公司 [ Dr. Hongjiu (Paul) Dai, Chief Executive Officer, Nanjing KAEDI Biotech ]

主旨演讲：The Latest Advancement in T-cell-based Cancer Immunotherapy
Abstract: Cancer is a leading cause of death worldwide. Traditional cancer treatments, including surgery, chemotherapy and radiation therapy, have demonstrated very limited efficacy for patients with late-stage disease. Cancer immunotherapy, particularly adoptive cell transfer, has shown great promise in the treatment of patients with late-stage disease, including those who are refractory to standard therapies. Chimeric antigen receptor (CAR)-T cells have achieved great success in treating hematological malignancies, while tumor infiltrating lymphocytes (TIL) and T cell receptor (TCR) -T cell-based immunotherapy have shown encouraging data for solid cancers. In this presentation, I will highlight the latest advancement in T-cell-based cancer immunotherapy based on TIL, TCR-T and CAR-T cells and discuss future directions and challenges in T cell-based cancer immunotherapy
王明军 教授, 执行院长, 深圳市因诺转化医学研究院 [ Dr. Mingjun Wang, Executive President, Shenzhen Institute for Innovation and Translational Medicine ]

主旨演讲：Mechanisms & Clinical Study of CAR-NK Cell Drugs to Treat Solid Tumors
Abstract: Chimeric antigen receptor T lymphocyte (CAR-T) technology has made remarkable success in the treatment of hematological malignancies. However, its intrinsic character of the technology unlikely leads to a large-scale production of standardized and homogenous cell drugs for cancer treatment. The ATCG Corp. has been pioneered on developing innovative “off-the-shelf” CAR-NK cell drugs for cancer immunotherapy. The ATCG research team, led by Dr. Huashun Li, has been based on natural killer cell line NK-92 as a platform to develop over 15 CAR stably expressing NK cell lines (CAR-NK) to treat different types of solid tumors. The preliminary clinical research studies have shown that ATCG427 CAR-NK therapy yields a remarkable response rate. In investigator initiated clinical study, Robo1 CAR-NK cells could effectively treat the advanced cancers with DCR as high as 76.5%, including but not limited to breast cancer, lung cancer, renal cancer, and pancreatic cancer. In addition, ATCG427 CAR-NK cells not only directly kill target tumor cells but also engage host NK cells and lymphocytes, leading to systemic activation of immunity against tumors. ATCG is a leading enterprise in the fast-growing tumor immunotherapy field .It has laid a solid foundation for the clinical trial of innovative cell drugs.
李华顺 博士, 总裁兼首席执行官, 阿思科力 [ Dr. Huashun Li, President and Chief Executive Officer, Asclepius Technology Company Group ]

主旨演讲：基于非病毒载体的CAR-T细胞肿瘤治疗 / Non-Viral CAR-T Cell Therapy for Tumor
-- 非病毒载体之于CAR-T肿瘤治疗的价值
-- 非病毒载体CAR-T药物研究
-- 非病毒载体CAR-T实体肿瘤治疗探索
孙艳 女士, 副总裁, 细胞药物BU总经理, 上海细胞治疗集团 [ Dr. Sun Yan, VP, General Manager, Cell Drug Business Unit, Shanghai Cell Therapy Group ]

主旨演讲：Progress on TCR-T Development and Solid Tumor Treatment
-- Recent progress on TCR-T product development
-- Clinical practice on TCR-T treating solid tumors
朱逸 博士, 亚太地区商务负责人, T-Cure Bioscience [ Dr. Yi Zhu, Head of Business Development Asia Pacific and COO, T-Cure Bioscience ]

主旨演讲：Surface Density of CAR Molecules Modulate the Kinetics of CAR-T Cells In Vivo
李建强 博士, 创始人兼首席科学官, 河北森朗生物 [ Dr. Jianqiang Li, Founder and Chief Scientific Officer, Hebei Senlang Biotech ]

主旨演讲：Clinical Development of CAR-T Cell Therapy and Next Generation CAR-T Cells
汪薇 博士, 临床开发副总裁, 科济生物医药有限公司 [ Dr. Wei Wang, Vice President of China Clinical Development, CARsgen Therapeutics ]

主旨演讲：The Research and Proceedings of CAR-T for Treating the AML
张继帅 博士, 首席科学官, 深圳普瑞金生物  [ Dr. Jishuai Zhang, Chief Scientific Officer, The Pregene Biopharma Company ]

主旨演讲：Cell Therapy Manufacturing Commercialization -- Strategy and Challenges
Harry Lam 博士, 执行副总裁, 技术运营, 上海药明巨诺生物科技有限公司 [ Dr. Harry Lam, Executive Vice President of Technical Operations, JW Therapeutics ]

主旨演讲： 利用流式细胞术 对CAR-T 细胞的鉴定与研究
• Flow cytometry can be helpful in CAR-T design and toxicity prediction
• Identify the quality of immune cells
• MRD detection after CAR-T
• Immune surveillance
• Cytokines by ELISA, detect more cytokines by FCM
王慧 博士, 临床诊断部 副主任, 流式细胞实验室 主任, 陆道培疫疗集团 [ Dr. Hui Wang, Deputy Director, Clinical Diagnostic Dept, Director, Flow Cytometry Lab, Lu Daopei Medical Group ]

圆桌讨论: Strengthening Collaboration and Revolution in Future CAR-T Cell Therapy and How Will it Scale over the Next Decades
Panelists:
林欣 教授，基础医学系系主任, 清华大学医学院
Alvin Luk 博士，首席执行官,  武汉纽福斯生物科技有限公司
刘必佐 先生，首席执行官 兼 首席财务官, 西比曼生物科技集团
何霆 博士，首席执行官, 北京艺妙神州医药科技有限公司
王立群 博士，首席执行官, 复星凯特生物科技有限公司

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