Month: 2024-11

Strasbourg, France & Tokyo, Japan, Nov 8, 2024 - (JCN Newswire via SeaPRwire.com) - Transgene (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, network and AI technologies, today announced 24.1 month median follow-up data from the ongoing randomized Phase I trial of TG4050 in the adjuvant treatment of head and neck cancers. The data will be presented in a poster at the Society for ImmunoTherapy of Cancer (SITC) 2024 Annual Meeting, November 9.TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.After a median follow up of 24.1 months, all 16 patients who received TG4050 as adjuvant immunotherapy after completion of an adjuvant standard of care remain disease-free and have not relapsed. Out of the 16 patients in the control observation arm, 3 patients have relapsed. There remains a high medical need for these head and neck cancer patients, as approximately 30% of them are expected to experience a relapse within 24 months after standard surgery and adjuvant chemoradiotherapy.Immune responses targeting selected neoantigens were identified in 100% of patients who received TG4050, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. An analysis over 7 months also shows that immune responses are sustained, during the induction and boost periods.All treatment-related adverse events continue to be mild to moderate.Pr. Le Tourneau, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator, said: "It is highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months. There remains a significant unmet need in head and neck cancer patients in the adjuvant setting. TG4050 has demonstrated its potential to prime an adaptive immune response against tumor antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma."Dr. Emmanuelle Dochy, Chief Medical Officer of Transgene, added: "We are very encouraged to observe that all the patients treated with our neoantigen cancer vaccine TG4050 remain disease-free after a median follow-up of 24.1 months. Looking at these results and at the long-lasting immune response, we are confident that TG4050 has the potential to benefit these patients, who still face a significant risk of relapse with current therapies. A Phase II part of our trial is currently enrolling patients internationally, with the aim of further confirming these promising findings."Motoo Nishihara, Corporate EVP, and CTO, at NEC, added: "These results illustrate the power of our collaboration with Transgene and our ability to develop a personalized approach to cancer patient treatment using our proprietary artificial intelligence and machine learning models. We have built a strong and compelling clinical data set to support the benefits of TG4050 as an individualized immunotherapy, and we remain committed to bringing novel AI-based treatments to patients across the globe."The SITC poster can be viewed in-person during the poster presentation at the SITC 2024 meeting and can be accessed on Transgene’s website on November 9.Building on these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer NCT04183166), which is currently enrolling patients in a Phase II part.Poster detailsAbstract Number: 650Title: Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma (HNSCC)Presenting Author: C. Le Tourneau – Institut CuriePoster Presentation Day: November 9About myvac®myvac® is a viral vector (MVA—Modified Vaccinia Ankara) 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 to recognize and destroy tumors using their 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 "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. Click here to watch a short video on myvac®.About TG4050TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. 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 and produced for each patient.About the clinical trialTG4050 is being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. In the Phase I part, thirty-two evaluable patients have been included in this trial under way internationally. The Phase II part is currently enrolling patients.About TransgeneTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The Company’s clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac® platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir. IO® viral backbone.With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.With its proprietary platform Invir. IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.Additional information about Transgene is available at: www.transgene.frFollow us on social media: X (formerly Twitter): @TransgeneSA—LinkedIn: @TransgeneAbout NEC’s Neoantigen Prediction SystemNEC’s neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T-cell response. With NEC OncoImmunity now on board, NEC continues to strengthen its top-class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide.For more information, visit NEC at www.nec.com.For additional information, please also visit NEC OncoImmunity at https://www.oncoimmunity.com/About NEC CorporationNEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of “Orchestrating a brighter world.” NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential.For more information, visit NEC at https://www.nec.com and NEC’s AI Drug Development Business at https://www.nec.com/en/global/solutions/ai-drug/ DisclaimerThis 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 Universal Registration Document, available on the AMF website (https://www.amf-france.org) or on Transgene’s website (www.transgene.fr). 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. Copyright 2024 JCN Newswire via SeaPRwire.com.

TOKYO, Nov 7, 2024 - (JCN Newswire via SeaPRwire.com) - Hitachi High-Tech Corporation ("Hitachi High-Tech") and The University of Tokyo ("UTokyo") have been conducting joint research ("this research") into practical applications of high-resolution Laser-PEEM(1) developed by UTokyo in the semiconductor manufacturing process. This research will be presented at MNC 2024 (International Microprocesses and Nanotechnology Conference 2024), which will be held in Kyoto Prefecture from November 12 to 15, 2024.Overview of Laser-PEEMLaser-PEEM can be faster image analysis compared to SEM(2) used in the semi-conductor wafer manufacturingprocess, and observation of the chemical information of materials and the non-destructive observation of three-dimensional structures on the nano-level used high- resolution technology developed by UTokyo. In this research, we conducted trials on the application of Laser-PEEM in the semiconductor field and have verified its effectiveness.We will continue to conduct research in collaboration with UTokyo by understanding the needs of semiconductor manufacturers to help resolve issues in the manufacturing and shipping processes.(1) Laser-PEEM: Laser-Photo Emission Electron Microscope(2) SEM: Scanning Electron MicroscopeBackgroundAs semiconductor device performance has improved with the progress that's been made in miniaturization and high integration, at present, nano-level circuit patterns are being formed using extreme ultraviolet (EUV) lithography. Asdevices become increasingly miniaturized and highly integrated, changes in 3D processing precision of circuit patternsand localized material properties in the manufacturing process have come to have a greater impact on device performance than ever before. For this reason, multi-point and varied inspections and measurements are becoming essential, and the need for improved inspection throughput is expected to continue to increase going forward.Hitachi High-Tech has been conducting joint research with UTokyo since 2020, which developed the high-resolutionLaser-PEEM technology, with the aim of resolving further issues facing customers by leveraging Hitachi High-Tech's expertise in supporting semiconductor manufacturing through high reproducibility and throughput.Details of This Research's Trials Using the Features of High-resolution Laser-PEEM1. Quick nano-scale observationLaser-PEEM irradiates the entire observation target with a laser instead of an electron beam, and obtains the observedimage by capturing the electrons emitted from the observation target with a camera. This research has verified that, using this method, it is possible to obtain a wider area of high-resolution data at once, thereby contributing tosubstantially shortening the inspection process compared to a SEM, which scans using an electron beam.2. Enables the observation of various chemical information of materialsThe semiconductor manufacturing process consists of three main processes: resist coating, exposure, and development. In order to inspect the shape of circuit patterns, we currently inspect the uneven patterns formed on thewafer surface after development. It is believed that yield could be improved if it were possible to inspect what are called latent image patterns, which are formed immediately after exposure and are chemically etched with no irregularities on the actual surface. In this research, we applied Laser-PEEM to latent image pattern observation anddemonstrated that it was possible to observe them at high resolution and with high throughput. This functionality is a technique that was not possible with SEMs, and we anticipate this could lead to the creation of new inspection markets going forward.3. Enables non-destructive observation of nanostructuresLaser-PEEM is capable of sensing at depths of approximately 10 to 100 nanometers, and we have demonstrated that it is able to "look through" and see whether defects are present in wafers and what caused them in a non-destructive manner. This makes it possible for the previous work of processing wafers to analyze the cause of faults to now be carried out non- destructively. We also expect to see more advances in moving to three-dimensions going forward,thereby contributing to reducing the workload involved in processing, as well as more accurate analysis.Future OutlookBy providing inspection and measurement equipment using electron beam technology and optical technology, Hitachi High-Tech continues to respond to our customers' various processing, measurement and inspection needs in the development and mass production of semiconductor devices. Looking to the future, the combination of this high-resolution technology developed by UTokyo and Hitachi High-Tech's automation and stabilization technology, together with an extensive customer network, will open up new possibilities for applying high-resolution Laser-PEEM in inspections and measurements in the cutting-edge semiconductor manufacturing processes.In addition, we anticipate that Laser-PEEM, which enables the acquisition of even more information from theobservation target, will contribute not only to the semiconductor field, but also to a wide range of industries andfundamental scientific research. As such, we will continue our research in the application of technology toward resolvinga wide range of social issues.We will continue to provide innovative and digitally enhanced solutions to our products for the upcoming technology challenges, and create new value together with our customers, as well as contributing to cutting-edge manufacturing.Related InformationToday, November 7, 2024, the Materials Innovation Research Center (MIRC), the University of Tokyo Collaborative Research Organization, the Institute for Solid State Physics, and the Graduate School of Frontier Sciences have issued a press release related to this research. Please see the link below for details.www.issp.u-tokyo.ac.jp/maincontents/news2.html?pid=24999 (Japanese only)About Hitachi High-TechHitachi High-Tech, headquartered in Tokyo, Japan, is engaged in activities in a broad range of fields, including manufacture and sales of clinical analyzers, biotechnology products, radiation therapy systems, semiconductor manufacturing equipment, analytical instruments, and analysis equipment. Also, we provide high value-added solutions in industrial fields such as mobility, connected, environment and energy, etc. Through business based on our core Observation, Measurement and Analysis technologies, we will contribute to the realization of a sustainable society by solving social issues.The company's consolidated revenues for FY2023 were approx. JPY 670.4 billion. For further information, visit www.hitachi-hightech.com/global/en/Contact:Makoto SakakibaraOpen Business Promotion Dept., Business Strategy Planning Div.,Nano-Technology Solution Business Group, Hitachi High-Tech CorporationEmail: makoto.sakakibara.yf@hitachi-hightech.com Copyright 2024 JCN Newswire via SeaPRwire.com.