Transgene and NEC Start Two Clinical Trials with TG4050, an Individualized AI-Powered Cancer Vaccine for Ovarian and Head & Neck Cancers


2020-01-09 14:08:43 BioSpace


TG4050 moves therapeutic vaccination into the digital age: combines Transgene’s expertise in viral vectors with NEC’s cutting-edge Artificial Intelligence capabilities Novel immunotherapy is fully tailored to each individual by generating an immune response that targets highly specific patient tumor mutations First patients enrolled in two Phase 1 trials at the Mayo Clinic and Toulouse Oncopole STRASBOURG, France & TOKYO--(BUSINESS WIRE)-- Regulatory News: Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, today announced that the first patients have been enrolled in the first-in-human trials evaluating TG4050, an individualized therapeutic vaccine based on the myvac™ technology and powered by NEC’s cutting-edge AI capabilities. In these Phase 1 trials, TG4050 is being administered to patients with head and neck cancer who have a high risk of relapse after surgery and patients with ovarian cancer after surgery and adjuvant therapy. Transgene’s highly innovative myvac™ technology allows the generation of a virus-based immunotherapy within a very short time frame while encoding patient-specific mutations identified and selected by NEC’s Neoantigen Prediction System. TG4050 has been designed to target up to 30 patient-specific neoantigens (cancer cell mutations). They are selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary immune data, allowing it to accurately prioritize and select the most immunogenic sequences. Transgene uses its expertise in viral vectorization via myvac™ to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Company has also set up a unique in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the clinical development of this novel therapeutic vaccine. “As each patient’s cancer is unique, we have developed a therapy that turns their solid tumor’s genetic signature into a powerful highly specific anticancer weapon. TG4050 is based on an MVA viral vector that has proven biological activity and has the ability to elicit an immune response against tumor antigens. Our partnership with NEC ensures that TG4050 is benefitting from its world-leading expertise in artificial intelligence and its unique algorithm that is used to select up to 30 patient-specific antigens that allow this novel vaccine to induce a strong immune response. We are convinced that TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer,” explained Philippe Archinard, Chairman and Chief Executive Officer of Transgene. “We are excited to enroll our first patients in these trials and see TG4050 advance to the clinic. This is another step closer towards the realization of an AI-driven individualized immunotherapy for each patient. Our unique partnership with Transgene enables us to leverage its significant clinical development know-how and proven viral vector delivery platform. We are hopeful that TG4050 will make a significant difference for patients throughout the world,” commented Osamu Fujikawa, Senior Vice President, NEC Corporation. A Phase 1 clinical trial of TG4050 is enrolling patients with ovarian cancer after surgery and first-line chemotherapy. This multicenter, one-arm trial will recruit patients in the USA and in France. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. Dr. Matthew Block, immunologist and medical oncologist at the Mayo Clinic, is conducting the trial in the USA; in France, the trial will be conducted by Dr. Martinez at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie. Another Phase 1 clinical trial of TG4050 is enrolling patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) who have received an adjuvant therapy after surgery. This multicenter, open label, randomized two arms trial will include patients in the UK and in France. Patients will receive either TG4050 monotherapy after completion of the adjuvant therapy or in combination with the standard of care at the time of recurrence. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. In France, the trial is being conducted by Pr. Delord at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie; in the UK, the trial is coordinated by Pr. Ottensmeier from Southampton University. Both studies are sponsored by Transgene and are co-financed by Transgene and NEC. About TG4050 TG4050 is an individualized immunotherapy based on Transgene’s myvac™ technology and powered by NEC’s artificial intelligence. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences. TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed for each patient and can be produced in a very short time frame. About myvac™ myvac™ is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac™-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded an “Investment for the Future” funding from Bpifrance for the development of its platform myvac™. TG4050 is the first myvac™-derived product being evaluated in clinical trials. About NEC’s Neoantigen Prediction System NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house major histocompatibility complex (MHC) binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient. About Transgene Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s clinical-stage programs are TG4001, a therapeutic vaccine against HPV-positive cancers, TG6002, an oncolytic virus for the treatment of solid tumors, and TG4050, the first individualized therapeutic vaccine based on the myvac™ platform. With its proprietary platform Invir.IO®, Transgene also builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: Follow us on Twitter: @TransgeneSA About NEC Corporation NEC Corporation is a leader in the integration of IT and network technologies that benefit businesses and people around the world. The NEC Group globally provides “Solutions for Society” that promote the safety, security, efficiency and equality of society. Under the company’s corporate message of “Orchestrating a brighter world,” NEC aims to help solve a wide range of challenging issues and to create new social value for the changing world of tomorrow. For more information, visit NEC at Disclaimer This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Document de Référence, available on the AMF website ( or on Transgene’s website ( Forward-looking statements speak only as of the date on which they are made and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. View source version on Transgene: Lucie Larguier Director Corporate Communications & IR +33 (0)3 88 27 91 04 NEC Corporation AI Drug Development Division Email: Media: Citigate Dewe Rogerson David Dible/Sylvie Berrebi + 44 (0)20 7638 9571 NEC Corporation: Joseph Jasper +81-3-3798-6511 Source: Transgene View this news release online at:
TG4050将治疗性疫苗接种移入数字化时代:将 Transgene 在病毒载体方面的专长与 NEC 尖端的人工智能能力结合起来 新的免疫疗法通过产生针对高度特异性肿瘤突变的免疫反应,完全适合每个个体 第一个病人在梅奥诊所和图卢兹 Oncoile 两个第一阶段试验中登记 STRASSBOURG , France &东京--(商业前景)----监管新闻: Transgene ( Paris : TNG )( Euronext Paris : TNG ),一家设计和开发治疗癌症的基于病毒的免疫疗法的生物技术公司,和 NEC 公司( NEC ; TSE :6701),一家领先的 IT 和网络技术,今天宣布第一个病人已经参加了第一次人体试验,评估 TG4050,一种基于 myvac ™技术的个体化治疗疫苗,由 NEC 尖端的人工智能能力提供动力。在这些第一阶段的试验中, TG4050被用于头颈癌患者,他们在手术后有很高的复发风险,在手术和辅助治疗后有卵巢癌患者。 Transgene 高度创新的 myvac ™技术允许在很短的时间内产生基于病毒的免疫疗法,同时编码由 NEC 的 NeoAnt 预测系统识别和选择的患者特异性突变。 TG4050已经被设计成针对多达30个病人特异性新抗原(癌细胞突变)。他们选择使用 NEC 的 NeoAnt 预测系统,这是一种先进的人工智能技术,已经应用于肿瘤领域。该预测系统基于20多年人工智能领域的专业知识,并接受了专有免疫数据的培训,使其能够准确地优先选择和选择最具免疫原性的序列。 Transgene 利用其在通过 myvac ™进行病毒矢量化方面的专长,将选定的新抗原序列纳入改良疫苗病毒 Ankara ( MVA )病毒载体的基因组中。本公司还设立了独特的内部良好生产实践( GMP )单位,专门生产本新型治疗性疫苗临床开发所需的 TG4050个性化批次产品。 “由于每个病人的癌症都是独一无二的,我们开发了一种治疗方法,将他们的实体肿瘤的基因特征转化为一种强大的特异性抗癌武器。TG4050是基于 MVA 病毒载体,该病毒载体已被证明具有生物活性,并有能力引发对肿瘤抗原的免疫反应。我们与 NEC 的合作确保 TG4050受益于其在人工智能领域的世界领先的专业知识及其独特的算法,该算法用于选择多达30个病人特异性抗原,使这种新型疫苗能够诱导强烈的免疫反应。Transgene 董事长兼首席执行官 Philippe Archinard 解释说:“我们相信, TG4050是免疫治疗和大数据科学的十字路口,它将预示着对抗癌症的新时代的开始。” “我们很高兴让我们的第一个病人参加这些试验,并看到 TG4050提前到诊所。这是另一个更接近实现 AI 驱动的个性化免疫治疗为每个病人。我们与 Transgene 的独特合作使我们能够利用其重要的临床开发技术和经证明的病毒载体交付平台。我们希望 TG4050能为全世界的患者带来显著的改变,” NEC 公司高级副总裁 OsamuFujikawa 说。 TG4050的一期临床试验是在手术和一线化疗后招募卵巢癌患者。这个多中心的一臂试验将在美国和法国招募病人。试验的终点包括治疗性疫苗的安全性、可行性和生物活性。梅奥诊所的免疫学家和医学肿瘤学家 MatthewBlock 博士正在美国进行试验;在法国,试验将由马丁内斯博士在图卢兹- Oncoile 和 Pr 进行。居里学院的勒图尔纳。 TG4050的另一期临床试验是为接受手术后辅助治疗的头颈部新诊断的、局部晚期的人乳头状瘤病毒(HPV)阴性鳞状细胞癌( SCCHN )患者进行登记。这一多中心,开放标签,随机两项武器试验将包括患者在英国和法国。患者将接受 TG4050单一治疗完成后,辅助治疗或结合标准的护理时,复发。试验的终点包括治疗性疫苗的安全性、可行性和生物活性。在法国,审判由 Pr 进行。Delord at Touluse-Oncoile and by Pr 。英国居里研究所的 Le Touneau ,该试验由 Pr 协调。来自南安普顿大学的 Ottensemeier 。 这两项研究均由 Transgene 资助,由 Transgene 和 NEC 共同资助。 约 TG4050 TG4050是一种基于 Transgene 的 myvac ™技术的个体化免疫疗法,由 NEC 的人工智能提供支持。这种基于病毒的治疗性疫苗编码由 NEC 的新抗原预测系统识别和选择的新抗原(病人特异性突变)。该预测系统基于20多年人工智能领域的专业知识,并接受了专有数据的培训,使其能够准确地优先选择和选择最免疫基因序列。 TG4050的目的是刺激患者的免疫系统,以诱导 T 细胞反应,能够识别和破坏肿瘤细胞基于自己的新抗原。这种个体化免疫疗法是为每个病人开发的,可以在很短的时间内产生。 关于 myvac ™ myvac ™是一个基于病毒载体( MVA )的个体化免疫治疗平台,已由 Transgene 开发,以针对实体肿瘤。myvac ™衍生产品旨在刺激患者的免疫系统,利用患者自身癌症特有的基因突变识别和摧毁肿瘤。Transgene 建立了集生物工程、数字化改造、矢量化技术和独特制造能力于一体的创新网络。Transgene 已从 Bpifrance 获得“未来投资”资金,用于开发其平台 myvac ™。TG4050是第一个在临床试验中被评估的 myvac ™衍生产品。 关于 NEC 的新抗原预测系统 NEC 的新抗原预测利用其专有的人工智能( AI )技术,如基于图的关系学习,结合其他数据来源,发现候选的新抗原目标。NEC 综合评价候选新抗原,主要集中在其内部主要组织相容性复合体( MHC )结合亲和力预测训练的公共和专有数据集。这使得 NEC 能够有效地优先考虑在单个病人中识别的大量候选新抗原。 关于 Transgene Transgene ( Euronext : TNG )是一家公开上市的法国生物技术公司,专注于设计和开发治疗癌症和传染病的靶向免疫疗法。Transgene 的程序利用病毒载体技术,目的是间接或直接杀死受感染或癌细胞。公司的临床阶段计划是 TG4001,一种治疗 HPV 阳性癌症的疫苗, TG6002,一种用于治疗实体瘤的溶瘤病毒,和 TG4050,第一个基于 myvac ™平台的个体化治疗疫苗。 拥有专有平台 Invir 。IO ®, Transgene 还基于其在病毒载体工程方面的专长设计了新一代多功能溶瘤病毒。 有关 Transgene 的更多信息可查阅: 。 关注 Twitter :@ TransgeneSA 关于 NEC 公司 NEC 公司在 IT 和网络技术的集成方面处于领先地位,这些技术有利于世界各地的企业和个人。全球 NEC 集团提供“社会解决方案”,促进社会的安全、安全、效率和平等。NEC 的目标是帮助解决一系列具有挑战性的问题,为未来不断变化的世界创造新的社会价值。有关详细信息,请访问 NEC 网站 。 免责声明 本新闻稿包含前瞻性陈述,该等陈述存在众多风险及不明朗因素,可能导致实际结果与预期结果出现重大差异。任何这些风险的发生都可能对公司的活动、观点、财务状况、结果、监管部门与发展阶段的协议以及发展产生重大负面影响。本公司产品商业化的能力取决于但不限于以下因素:阳性的临床前数据可能不能预测人体临床结果、临床研究的成功、获得融资的能力和/或产品制造、开发和商业化的合作伙伴关系;以及政府监管机构的营销批准。有关可能导致公司实际业绩、财务状况、业绩或业绩与前瞻性陈述中的风险和不确定性的讨论,请参见 R é f é rence 文件中的风险因素(“风险因素”)一节。可在 AMF 网站( )或 Transgene 网站( )上查阅。前瞻性陈述仅在作出之日才会发表, Transgene 不承担更新这些前瞻性陈述的义务,即使将来有新的信息。 查看 businesswire 上的源代码。com : Transgene : Lucie Larguier 公司传讯及 IR 总监 +33(0)388279104 投资关系@ NEC 公司 AI 药物发展科 电子邮件:联系人@ 媒体: 城市大门 Dewe Rogerson David Dible / Sylvie Berrebi +44(0)2076389571 genere @ NEC 公司: 约瑟夫·贾斯珀 j-jasper @ +81-3-3798-6511 来源: Transgene 在线查看本新闻稿,网址为: en