Polymer protection for vaccines and drugs

TSUKUBA, Japan, Dec 9, 2022 - (ACN Newswire via SEAPRWire.com) - A biocompatible polymer could help deliver vaccines and drugs with reduced risk of the rare dangerous adverse reaction called anaphylaxis. Researchers at the National Institute of Advanced Industrial Science and Technology (AIST) in Japan have developed the polymer and performed preliminary tests, which they report in the journal Science and Technology of Advanced Materials.A liposome (left) containing a vaccine is commonly coated with polyethylene glycol (PEG) but it can trigger an allergic reaction to some recipients. A newly developed lipid (right) could serve as a safer, alternative liposome-coating while retaining the vaccine longer in the body.Until now, the polymer of choice for encasing and delivering vaccines has been poly(ethylene glycol) (PEG). This synthetic, flexible, water-soluble material has been used to surround some COVID-19 vaccines carried within the tiny spherical packages known as liposomes.Unfortunately, some recipients have suffered an anaphylactic reaction to PEG, in which the immune system mounts an allergic response to the foreign material. Symptoms of anaphylaxis range from minor skin irritations, to breathing difficulty, nausea and, in the worst cases, unconsciousness and sudden death.The alternative polymer is a form of fatty biomolecule called a lipid, and is conjugated to 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer.This new substance spontaneously binds to the outside of liposome particles when mixed with them in water. Crucially, the polymer is not recognized by the antibodies that the body can generate in response to PEG, and tests suggest it does not stimulate any other antibodies that could cause an allergic reaction. This should allow coated liposomes containing a vaccine to be retained in the body for a longer time without being cleared by the immune system, in addition to avoiding anaphylaxis."We have also found that the polymer avoids other interactions with proteins in the blood that might otherwise interfere with its effects, and it also prevents liposomes from aggregating together," says molecular engineer Yuji Teramura of the AIST team.Tests confirm the coated liposomes can remain stable in storage for 14 days, sufficient for real clinical applications."All the indications suggest that our technology should be suitable for delivering vaccines into patients who develop anaphylaxis in response to PEG," Teramura concludes.The polymer must now be thoroughly tested in various real vaccine applications. The team is moving into this next crucial phase of the development process, prior to eventual clinical trials in humans.Provided the animal and subsequent clinical trials go well, the technology should offer opportunities for delivering drugs into the body, in addition to vaccines. Delivery systems such as liposomes are sometimes needed to protect drugs from biochemical processes that might degrade them. This can ensure that they reach the target disease tissues while remaining in their active form.Further informationYuji TeramuraNational Institute of Advanced Industrial Science and Technology (AIST)Email: y.teramura@aist.go.jpAbout Science and Technology of Advanced Materials (STAM)Open access journal STAM publishes outstanding research articles across all aspects of materials science, including functional and structural materials, theoretical analyses, and properties of materials. https://www.tandfonline.com/STAMDr Yasufumi NakamichiSTAM Publishing DirectorEmail: NAKAMICHI.Yasufumi@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Gradiant, Global Water Solutions Provider, Awarded $20M in New Contracts in India

New projects deliver Gradiant's full-technology stack solutions to India's renewable energy and industrial clientsBOSTON, Nov 16, 2022 - (ACN Newswire via SEAPRWire.com) - Gradiant, a global solutions provider for advanced water and wastewater treatment, is pleased to announce awards of $20 million in new contracts in September and October 2022. The awards are for clients in the manufacturing of photovoltaic cells (or solar cells) renewable energy and industrial protective equipment. All three projects will be delivered as design-build contracts.One of the largest solar companies in India has partnered with Gradiant at a manufacturing site in the Western Region for ammonia and fluoride removal and wastewater treatment. The new facility will recover, neutralize, and treat complex wastewater rinse streams from photovoltaic cell production to levels that meet the client's sustainability goals and local discharge limits.Gradiant has also partnered with a leader in the renewable energy business for the design-build of two facilities for ultrapure water and wastewater treatment to support a new photovoltaic cell manufacturing site also in Western Region. The project will include Gradiant's patented RO InfinityTM membrane technology to treat industrial wastewater streams. The zero liquid discharge (ZLD) facility will reduce wastewater to only salt and solid wastes."We are experiencing strong growth in the India market across multiple strategic verticals," said Prakash Govindan, COO of Gradiant. "India was already one of the fastest growing economies in the world and is well positioned to gain as global companies review their sourcing and manufacturing footprints to de-risk and diversify their supply chains. We are also witnessing a clean energy transition in India, as the country builds out renewable energy infrastructure and its supply to the world. This local market has always been important to India, and Gradiant is ready to support our clients with advanced water solutions as they shift or double-down their local manufacturing operations."In addition to these renewable energy projects, Gradiant is working with a leading manufacturer of industrial protective equipment for their new facility in Southern India. Gradiant will deliver an effluent treatment and ZLD waste minimization system. The plant will feature Gradiant's Carrier Gas ExtractionTM (CGE) for ZLD and SmartOpsTM for AI-powered asset performance optimization, and a membrane biological reactor (MBR) for advanced wastewater treatment.Gradiant entered the India market in 2018 to engage with major international and domestic companies to solve their advanced water and wastewater challenges in water recycling, minimum and zero liquid discharge, and ultrapure water. Clients are served by in-country expertise from Gradiant's main office in Chennai while collaborating and leveraging global process and engineering resources. The India team is comprised of 80 expert engineers and staff today, with plans to increase headcounts across the country.About GradiantGradiant is a global solutions provider for advanced water and wastewater treatment. With a full suite of differentiated and proprietary end-to-end solutions, powered by the top minds in water, Gradiant serves its clients' mission-critical operations in the world's essential industries. Gradiant was founded at the Massachusetts Institute of Technology (MIT) and is uniquely positioned to address the world's increasing challenges created by industrialization, population growth, and water stress. Today, with over 450 employees, Gradiant operates from its global headquarters in Boston, regional headquarters and global technology labs in Singapore, and offices across twelve countries. For more information, please visit www.gradiant.com.Corporate Contact:Felix WangGradiant, VP of Marketingfwang@gradiant.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Revealing crystal structures robotically

TSUKUBA, Japan, Dec 2, 2022 - (ACN Newswire via SEAPRWire.com) - Researchers at the National Institute for Materials Science (NIMS) in Japan have automated a complex and labour-intensive process for analysing the results of X-ray diffraction studies, which are used to determine the structure of crystalline materials. The team described the development and application of their technique in the journal Science and Technology of Advanced Materials: Methods.By combining machine learning with robotic process automation, researchers automated a mathematical procedure that determines the structure of crystalline materials. (Credit: ktsdesign/123rf)X-rays fired at a crystal interact with the geometric arrangement of its particles and are diffracted in many directions in a complex pattern of rays that depends on the crystal's precise structure. Experts analyse the pattern and intensity of the diffracted X-rays to determine the crystal's internal arrangement. This is a powerful and widely used process for revealing the three-dimensional atomic structure of new materials.A well-established mathematical procedure, called Rietveld analysis, is used for interpreting X-ray diffraction data, but it is time-consuming and requires manual trial-and-error refinement of the results."To reduce human costs and resources, we have developed a robotic process automation (RPA) system that we apply to an existing Rietveld analysis program called RIETAN-FP," says Ryo Tamura of the NIMS team. "By using our new procedure, with the help of machine learning, we have succeeded in performing Rietveld analysis automatically," Tamura adds.The automation can be run on a personal computer and can reduce human error as well as greatly speed up the data analysis.Tamura explains that the field of materials science already relies on numerous graphical user interface (GUI) applications to calculate a material's properties, control experimental equipment, or analyse material data. He says that combining this new RPA and machine learning ability with these applications achieves a "closed loop" to automatically design and analyse materials with minimal human intervention.The researchers verified the accuracy of their procedure by analysing samples of powdered compounds whose crystal structures are already known. The ability to determine the structures from powdered samples is one of the great strengths of Rietveld analysis. It avoids the need to grow large single crystals, which can be extremely difficult to obtain for some materials."Automating Rietveld analysis brings a very powerful new tool into the entire field of materials science," Tamura concludes.The researchers are now working to further refine their procedure to make it suitable for more complex crystal structures. Another aim is to explore the use of their machine learning RPA strategy for more general applications in materials science. The possibilities include numerous simulation methods used for calculating material properties, and also applications for controlling experimental equipment. The success achieved thus far with X-ray diffraction could just be the start for Rietveld robotics.Further informationRyo Tamura National Institute for Materials ScienceEmail: tamura.ryo@nims.go.jpAbout Science and Technology of Advanced Materials: Methods (STAM Methods)STAM Methods is an open access sister journal of Science and Technology of Advanced Materials (STAM), and focuses on emergent methods and tools for improving and/or accelerating materials developments, such as methodology, apparatus, instrumentation, modeling, high-through put data collection, materials/process informatics, databases, and programming. https://www.tandfonline.com/STAM-MDr. Yasufumi NakamichiSTAM Methods Publishing DirectorEmail: NAKAMICHI.Yasufumi@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Gradiant, Global Water Solutions Provider, Awarded $20M inNew Contracts in India

New projects deliver Gradiant's full-technology stack solutions to India's renewable energy and industrial clientsBOSTON, Nov 16, 2022 - (ACN Newswire via SEAPRWire.com) - Gradiant, a global solutions provider for advanced water and wastewater treatment, is pleased to announce awards of $20 million in new contracts in September and October 2022. The awards are for clients in the manufacturing of photovoltaic cells (or solar cells) renewable energy and industrial protective equipment. All three projects will be delivered as design-build contracts.One of the largest solar companies in India has partnered with Gradiant at a manufacturing site in the Western Region for ammonia and fluoride removal and wastewater treatment. The new facility will recover, neutralize, and treat complex wastewater rinse streams from photovoltaic cell production to levels that meet the client's sustainability goals and local discharge limits.Gradiant has also partnered with a leader in the renewable energy business for the design-build of two facilities for ultrapure water and wastewater treatment to support a new photovoltaic cell manufacturing site also in Western Region. The project will include Gradiant's patented RO InfinityTM membrane technology to treat industrial wastewater streams. The zero liquid discharge (ZLD) facility will reduce wastewater to only salt and solid wastes."We are experiencing strong growth in the India market across multiple strategic verticals," said Prakash Govindan, COO of Gradiant. "India was already one of the fastest growing economies in the world and is well positioned to gain as global companies review their sourcing and manufacturing footprints to de-risk and diversify their supply chains. We are also witnessing a clean energy transition in India, as the country builds out renewable energy infrastructure and its supply to the world. This local market has always been important to India, and Gradiant is ready to support our clients with advanced water solutions as they shift or double-down their local manufacturing operations."In addition to these renewable energy projects, Gradiant is working with a leading manufacturer of industrial protective equipment for their new facility in Southern India. Gradiant will deliver an effluent treatment and ZLD waste minimization system. The plant will feature Gradiant's Carrier Gas ExtractionTM (CGE) for ZLD and SmartOpsTM for AI-powered asset performance optimization, and a membrane biological reactor (MBR) for advanced wastewater treatment.Gradiant entered the India market in 2018 to engage with major international and domestic companies to solve their advanced water and wastewater challenges in water recycling, minimum and zero liquid discharge, and ultrapure water. Clients are served by in-country expertise from Gradiant's main office in Chennai while collaborating and leveraging global process and engineering resources. The India team is comprised of 80 expert engineers and staff today, with plans to increase headcounts across the country.About GradiantGradiant is a global solutions provider for advanced water and wastewater treatment. With a full suite of differentiated and proprietary end-to-end solutions, powered by the top minds in water, Gradiant serves its clients' mission-critical operations in the world's essential industries. Gradiant was founded at the Massachusetts Institute of Technology (MIT) and is uniquely positioned to address the world's increasing challenges created by industrialization, population growth, and water stress. Today, with over 450 employees, Gradiant operates from its global headquarters in Boston, regional headquarters and global technology labs in Singapore, and offices across twelve countries. For more information, please visit www.gradiant.com.Corporate Contact:Felix WangGradiant, VP of Marketingfwang@gradiant.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

New data extracted from old for materials databases

TSUKUBA, Japan, Nov 7, 2022 - (ACN Newswire via SEAPRWire.com) - A new approach uses data from one type of test on small metal alloy samples to extract enough information for building databases that can be used to predict the properties and potentials of new materials. The details were published in the journal Science and Technology of Advanced Materials: Methods.The scientists used computer simulations to build database of material properties.The Scientists found a way to use topography around indentation impression to predict other properties measured by a tensile or compression test.The test is called instrumented indentation. It involves driving an indenter tip into a material to probe some of its properties, such as hardness and elastic stiffness. Scientists have been using the data extracted from instrumented indentation to estimate the stress-strain curve of materials using computational simulations. This curve, and the data it provides, is important for understanding a material's properties. That data is also used for building massive materials databases, which can be used, in conjunction with artificial intelligence, for predicting new materials.A problem scientists face is that this approach for estimating material properties is limited when it comes to materials called 'high work-hardening alloys': metal alloys, like steel, that are strengthened through physical processes like rolling and forging. Only so much information can be estimated from the curve of these materials. To get the necessary additional information needed to determine their properties, more experiments would need to be done, which costs time, effort and money.Ta-Te Chen of the University of Tsukuba and Ikumu Watanabe of the National Institute for Materials Science in Japan have developed a new computational approach to extract that additional information from instrumented indentation tests on work-hardening alloys."Our approach builds on an already-existing model, making it ready for use in industry. It is also applicable to existing data, including hardness," says Watanabe.The approach involves combining the results from two computational models, the power-law and linear hardening models, which produce their own individual stress-plastic strain curves from information gathered from indentation tests. Combining the data from both curves provides the extra data that, when added to the original stress-strain curve, shows a more holistic picture of the work-hardening alloys' properties.The scientists validated their approach by using it on a high-work-hardening stainless steel.We have extended this approach to also evaluate mechanical properties at elevated temperatures, which can contribute to the development of high-temperature alloys," says Chen.Further informationIkumu WatanabeNational Institute for Materials ScienceEmail: WATANABE.Ikumu@nims.go.jpAbout Science and Technology of Advanced Materials: Methods (STAM Methods)STAM Methods is an open access sister journal of Science and Technology of Advanced Materials (STAM), and focuses on emergent methods and tools for improving and/or accelerating materials developments, such as methodology, apparatus, instrumentation, modeling, high-through put data collection, materials/process informatics, databases, and programming. https://www.tandfonline.com/STAM-MDr. Yasufumi NakamichiSTAM Methods Publishing DirectorEmail: NAKAMICHI.Yasufumi@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Hitachi Astemo develops Steer-by-Wire prototype with advanced steering and failsafe function

TOKYO, Oct 3, 2022 - (JCN Newswire via SEAPRWire.com) - Hitachi Astemo, Ltd.has developed a Steer-by-Wire prototype for vehicles, which actuates the tires not mechanically, but through the electric control of steering wheel inputs. The prototype not only realizes smooth, effortless steering wheel operation, but also redundancy through a fail-safe function that enables the continued operation in the event of a failure.Steer-by-Wire with redundancyIn anticipation of the evolution of autonomous driving, Hitachi Astemo and Hitachi, Ltd. are combining resources(1) to realize the practical application of a Steer-by-Wire that not only improves safety and comfort, but also realizes a greater degree of freedom in layout design, which is achieved by linking the steering system and wheel-turning system actuators using electrical signals.Normally, the driver infers the road surface condition from the steering reaction force of the steering wheel and use that information in operating the vehicle. With Steer-by-Wire, Hitachi Astemo leverages the advanced steering feel technology developed through the former Showa Corporation's many years of extensive research. In addition, Hitachi Astemo and Hitachi, Ltd. Research & Development Group have jointly developed a function that conveys when the vehicle body has not turned during inputs of the steering wheel. Furthermore, Hitachi Astemo is leveraging industry-leading skidding control technology developed by former Hitachi Automotive Systems, which suppresses external interference from road surface irregularities, such as wheel tracks on snowy roads, to minimize the need for steering corrections by the driver.To address the concern of Steer-by-Wire functionality in the event of failure, Hitachi Astemo's prototype has a failsafe function, which adopts a two-system approach for the power source and wire harness that connect the actuator on the steering side and actuator on the wheel turning side; triples both the circuits in the steering wheel angle sensor in the steering side actuator and circuits in the wheel turning side actuator; and controls the braking force of the four wheel brakes while linking it to the vehicle steering function. This enables continued operation even in the event of failure or circuit loss, thereby enhancing safety.Hitachi Astemo is committed to strengthening its business and delivering technological innovation through a strategic business portfolio, which consists of the Powertrain & Safety Systems business, Chassis business, Motorcycle business, Software business and Aftermarket business. Aiming for a better environment globally and growth around the pillars of "green," "digital," and "innovation," we will deliver highly efficient internal combustion engine systems; electric systems that reduce emissions; autonomous driving for improved safety and comfort; advanced driver assistance systems; and advanced chassis systems. Through such advanced mobility solutions, we will contribute to realizing a sustainable society and provide enhanced corporate value for our customers.(1) A device that converts power from motive force or driver operation into some kind of action.For more information, please visit the Hitachi Astemo website: www.hitachiastemo.com/en/ Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Novel patching material for bone defects

TSUKUBA, Japan, Jun 27, 2022 - (ACN Newswire via SEAPRWire.com) - Ceramics and metals have been used for a while as structural materials to repair bones and joints. In the past, scientists engineered bioinert materials, which do not bond to bones directly; bioactive materials that can bond to bones; and bio-absorbable materials that are categorized in bioactive materials but they are absorbed by the body over time and are replaced by advancing bone tissue. A new bio-responsive ceramic can be used to repair bone defectsWith an enzyme found in blood, different types of salts were converted to hydroxyapatite, a bone mineralNow, a fourth type of bone repairing materials has been found: a bio-responsive ceramic that interacts with an enzyme found in blood to be absorbed into the body at a precise and predictable rate.The research was done by Taishi Yokoi, an associate professor at the Institute of Biomaterials and Bioengineering at Tokyo Medical and Dental University, and his colleagues. The study was published in May in Science and Technology of Advanced Materials."Extending healthy life expectancy is an important issue for all of us," Yokoi says. "Bone repairing materials aid in the recovery of bone defects and help improve quality of life."At the heart of this discovery is a biological reaction: an enzyme called alkaline phosphatase (ALP), which is present in human serum and reacts with various phosphate esters to generate bone mineral known as hydroxyapatite.The scientists mimicked this process using a simulated body fluid that contained the enzyme ALP. They placed four different salts in a simulated body fluid containing or lacking the enzyme ALP. The salts were calcium salts of methyl phosphate (CaMeP), ethyl phosphate (CaEtP), butyl phosphate (CaBuP) and dodecyl phosphate (CaDoP). The phosphate component of each of these salts has an alkyl group at its end - a chain composed of hydrogen and carbon atoms - of differing lengths.The scientists found that the first three salts were converted to hydroxyapatite, but only in the presence of ALP. Interestingly, the length of the alkyl group on the phosphate ester determined the rate at which this reaction happens. With more research, the scientists think that this could allow greater control of the bone healing process in the body."We expect the findings of this study will be applied towards designing and developing novel bone-repairing materials with precisely controlled degradation and resorption rates inside the body," says Yokoi. Further informationTaishi YokoiTokyo Medical and Dental UniversityEmail: yokoi.taishi.bcr@tmd.ac.jpResearch paper: https://www.tandfonline.com/doi/full/10.1080/14686996.2022.2074801About Science and Technology of Advanced Materials (STAM)Open access journal STAM publishes outstanding research articles across all aspects of materials science, including functional and structural materials, theoretical analyses, and properties of materials. https://www.tandfonline.com/STAMMikiko TanifujiSTAM Publishing Director Email: TANIFUJI.Mikiko@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

Eisai Contributes to the Science of Cancer Medicine at ASCO 2022

TOKYO, May 27, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7. Notable presentations include a poster discussion of safety and efficacy data (NCT03386942; Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942; Abstract: #3090)."Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai's first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."New research from the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, includes subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (RCC) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (EC). A poster discussion will evaluate the impact of subsequent therapies in patients with advanced RCC receiving the combination (NCT02811861; Abstract: #4514); while a poster presentation will discuss the efficacy of next line therapy after treatment with lenvatinib plus pembrolizumab in advanced EC (NCT03517449; Abstract: #5587)."The combination of lenvatinib plus pembrolizumab has helped to expand physicians' arsenal of treatment options for patients living with advanced renal cell carcinoma and advanced endometrial carcinoma around the world," said Richard C. Woodman, MD, Chief Clinical Officer, Oncology Business Group at Eisai. "Our data at ASCO 2022 demonstrate our commitment to continuing to investigate the combination through post-hoc analyses with the goal of providing healthcare professionals with tools to support them in making better-informed treatment decisions for their patients."In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co- development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 20 trials have been initiated under the LEAP clinical program, which is evaluating the combination across more than 10 different tumor types.In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating farletuzumab ecteribulin in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.For more information, visit www.eisai.com/news/2022/pdf/enews202241pdf.pdf.Media Inquiries:Public Relations DepartmentEisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Machine learning speeds up search for new sustainable materials

TSUKUBA, Japan, May 25, 2022 - (ACN Newswire via SEAPRWire.com) - Researchers from Konica Minolta and the Nara Institute of Science and Technology in Japan have developed a machine learning method to identify sustainable alternatives for composite materials. Their findings were published in the journal Science and Technology of Advanced Materials: Methods.Researchers are looking for sustainable options, such as recyclable materials or biomass, to substitute the constituent materials in composites which are used in various applications including electrical and information technologies.Composite materials are compounds made of two or more constituent materials. Due to the complex nature of the interactions between the different components, their performance can greatly exceed that of single materials. Composite materials, such as fibre-reinforced plastics, are very important for a wide range of industries and applications, including electrical and information technologies.In recent years, there has been increasing demand for more environmentally sustainable materials that help reduce industrial waste and plastic use. One way to achieve this is to substitute the constituent materials in composites with recyclable materials or biomass. However, this can reduce performance compared to the original material, not only due to the features of the individual constituent materials, such as their physicochemical properties, but also due to the interactions between the constituents."Finding a new composite material that achieves the same performance as the original using human experience and intuition alone takes a very long time because you have to evaluate countless materials while also taking into account the interactions between them," explains Michihiro Okuyama, assistant manager at Konica Minolta, Inc.Machine learning offers a potential solution to this problem. Scientists have proposed several machine learning methods to conduct rapid searches among a large number of materials, based on the relationship between the materials' features and performance. However, in many cases the properties of the constituent materials are unknown, making these types of predictive searches difficult.To overcome this limitation, the researchers developed a new type of machine learning method for finding alternative materials. A key advantage of the new method is that it can quantitatively evaluate the interactions among the component materials to reveal how much they contribute to the overall performance of the composite. The method then searches for replacement constituents with similar performance to the original material. The researchers tested their method by searching for alternative constituent materials for a composite consisting of three materials - resin, a filler and an additive. They experimentally evaluated the performance of the substitute materials identified by machine learning and found that they were similar to the original material, proving that the model works."In developing alternatives, that make up composite materials, our new machine learning method removes the need to test large numbers of candidates by trial and error, saving both time and money." says Okuyama.The method could be used to quickly and efficiently identify sustainable substitutes for composite materials, reducing plastic use and encouraging the use of biomass or renewable materials.Further informationMichihiro OkuyamaKONICA MINOLTA, INC.Email: michihiro.okuyama@konicaminolta.comAbout Science and Technology of Advanced Materials: Methods (STAM Methods)STAM Methods is an open access sister journal of Science and Technology of Advanced Materials (STAM), and focuses on emergent methods and tools for improving and/or accelerating materials developments, such as methodology, apparatus, instrumentation, modeling, high-through put data collection, materials/process informatics, databases, and programming. https://www.tandfonline.com/STAM-MDr. Masanobu NaitoSTAM Methods Publishing DirectorEmail: NAITO.Masanobu@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ASEAN Ceramics Thailand 2022

Southeast Asia’s leading international exhibition of machinery, technology and materialsfor manufacturing advanced ceramics. BANGKOK, Mar 31, 2022 – (ACN Newswire) – ASEAN Ceramics 2022 is all set to take place from 30th November – 2nd December 2022 in Thailand. Messe Munchen, through their Southeast Asian operation, MMI Asia, announced its collaboration with AES (Asian Exhibition Services) on 15th September 2021, to take ASEAN Ceramics to a new international level of excellence in the two key markets for the region — Thailand and Vietnam. Through shared expertise and synergies, the first edition of this partnership would establish itself as the most pivotal event for the industry in Southeast Asia, with a common goal to enhance the visibility of advanced ceramic products and technology. The exhibition and conference will continue to alternate between Thailand and Vietnam every year. Over the course of 3 days, over 100 exhibitors and 4000 visitors are expected from across the world, who will share their products and technologies, extending from classic ceramics through industrial ceramics, ceramic engineering to technical ceramics and powder metallurgy. The event will provide an extensive engagement in ASEAN for global participants who would be able to leverage on Messe Munchen’s strengths through the Ceramitec (Munich) network and Indian Ceramics Asia. Alongside the exhibition, ASEAN Ceramics will also host a conference over three days led by a series of presentations and panel discussions by renowned speakers on several topics, ranging from new research to global innovation trends and their impact on the world ceramics industry. The conference would strive to amalgamate the knowledge of current and developing ceramic technology, analytics, and product design and keep high level plenary sessions intensely thought provoking. Our special focus will be on sustainability, shift towards circular economy in ceramics, advanced ceramic battery production, 3D printing, durability, green energy, energy-efficiency, digitalization and ongoing research and innovation et al. ASEAN Ceramics 2022 will promote industry knowledge, collaboration and growth through an exchange of ideas, fostering relationships, bringing new technologies and solutions and opening markets further. The exhibition and conference provide the ASEAN region access to the world’s most advanced technologies, equipment, solutions, knowledge and best practices in the ceramics industry. Since its inception in 2013, the exhibition has provided an exceptional platform for industry leaders to come together, interact, network and share their expertise with prominent decision makers – while strengthening their foothold on one of world’s most dynamic regions for the ceramics industry. About MMI Asia Pte Ltd MMI Asia, established in 1992 is a wholly owned subsidiary of one of the world’s largest and leading exhibition organizers, Messe Munchen GMBH (MMG). MMG is the owner andorganizer of the world’s leading ceramics trade fair, Ceramitec, organized every two years in Munich. More information available on:ASEAN Ceramics: www.aseanceramics.comMMI Asia Pte Ltd: www.mmiasia.comCeramitec: www.ceramitec.comIndian Ceramics Asia: www.indian-ceramics.com

ATAC and Toyota Establish New Initiative to Support the Social Implementation of Innovative Technologies Begin Collaborations with Universities

Toyota City, Japan, Mar 14, 2022 - (JCN Newswire via SEAPRWire.com) - Society is changing at unprecedented speeds, as exemplified by carbon neutrality initiatives and the advance of digital transformation, and there are similarly unprecedented expectations for innovative technologies. The fusion of technologies across industry boundaries is becoming increasingly important, as is already happening in the digital domain.For these reasons, there is a growing need to create vast, virtuous cycles by nurturing the seeds of outstanding technologies in society, linking them to economic value, and recycling them into new technologies that will inspire further innovations.Aware of such a need, Advanced Technology Acceleration Corporation (ATAC) and Toyota Motor Corporation (Toyota) launched a new joint initiative in May 2021, entitled Innovative Technology Acceleration Platform (ITAP), with the goal of contributing to the research, development, and social implementation of outstanding technologies in Japan.ATAC is a company that takes a hands-on approach in supporting the commercialization of advanced technologies, such as incubating startups and engaging in industry-academia collaborations through its extensive networks with universities and research organizations and knowledge of technology incubation. Toyota is engaged in cutting-edge technological research in the field of mobility and beyond, and boasts expertise and networks cultivated through TPS and other manufacturing processes.ITAP fuses the knowledge and networks of the two companies with the goal of providing extraordinarily dynamic and agile support for the exploration, social implementation, and commercialization of innovative technologies. The Platform will provide support to universities, research organizations, and tech startups in wide-ranging fields, including carbon neutrality, materials, robots, human augmentation(1), energy, semiconductors, AI, and digital.ATAC and Toyota have signed a basic agreement to collaborate in technology incubation with the University of Tokyo's School of Engineering, Tokyo Institute of Technology, and Nagoya University. Comments from the signatories of the three universities are given below:Takao Someya, Dean of the Graduate School of Engineering, the University of TokyoThe Faculty of Engineering and the Graduate School of Engineering are actively collaborating with various industries to contribute both to the resolution of social issues and the development of highly skilled engineers capable of resolving them. I have great expectations for ITAP, a joint initiative of ATAC and Toyota; by working together with ITAP, I hope to further accelerate the use of engineering knowledge in creating value.Kazuya Masu, President of Tokyo Institute of TechnologyFor industry and academia to conduct incubation activities that leverage their respective knowledge and expertise, it is important that both sides amass experience working together across a number of actual cases. ATAC has the know-how for commercializing advanced technologies, while Toyota is a driving force for commercialization in wide-ranging fields; I have great hopes that, through ITAP, they will actively promote these incubation activities.Akihiro Sasoh, Director of Academic Research & Industry-Academia-Government Collaboration, Nagoya UniversityIt is my understanding that the role of academia in supporting startups is to nurture ventures leveraging entrepreneurship education and research seeds. ITAP provides various supports for advanced technological research and social implementation from seed stage. I have very high expectations of ITAP's activities as a new form of collaboration between industry and academia.ATAC is a hands-on incubation company for advanced technologies. Going forward, it intends to identify the potential of various technologies, fully utilize the industry networks of the IGPI Group, and carry out the research & development, social implementation, and commercialization of such technologies.Toyota's Mission is "Producing Happiness for All." It seeks to achieve its mission by promoting research into advanced technologies with an increasingly diverse range of partners, including universities and research organizations, in the field of mobility and beyond.(1) Human augmentation refers to the technological alteration of the human body to enhance physical or mental capabilities.(2) One of the investors that can consider participation in fundraising of startups under ITAP activities. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma

TOKYO, Mar 7, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada)'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These results were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021, and published in the New England Journal of Medicine in January 2022.(1)In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p LENVIMA plus KEYTRUDA was previously approved under accelerated approval process in Taiwan, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation based on data from the Study 111/KEYNOTE-146 trial. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from Study 309/KEYNOTE-775. Endometrial cancer is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium.(3) Worldwide, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers in 2020.(4) In Taiwan, there were more than 2,700 new cases of uterine body cancer and nearly 400 deaths from the disease in 2018.(5) The five-year relative survival rate for metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.(6) Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals. *In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A. About LENVIMA (lenvatinib mesylate)LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it has been approved in combination with KEYTRUDA as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy and with radically unresectable or metastatic renal cell carcinoma. About Study 309/KEYNOTE-775 TrialThe approval was based on data from Study 309/KEYNOTE-775 (ClinicalTrials.gov, NCT03517449), a Phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. The primary efficacy outcome measures were OS, and PFS as assessed by blinded independent central review (BICR) according to RECIST v1.1. Patients were randomized 1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks) or investigator's choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). Treatment with LENVIMA plus KEYTRUDA continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for KEYTRUDA, a maximum of 24 months. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.In Taiwan, Eisai's pharmaceutical sales subsidiary Eisai Taiwan Inc. is marketing Lenvima and is co-commercializing it with a local branch of Merck & Co., Inc., Kenilworth, N.J., U.S.A. (1) V. Makker. et al. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. The New England Journal of Medicine. bit.ly/3HPQ59b(2) The information listed in Taiwanese Package insert(3) American Cancer Society, "Causes, Risks, Prevention." Endometrial Cancer. bit.ly/3HNy6jy(4) International Agency for Research on Cancer, World Health Organization. "Corpus uteri Fact Sheet." Cancer Today, 2020. bit.ly/35tT3TP(5) Taiwan Cancer Registry 2018 Report.(6) American Cancer Society, "Survival Rates for Endometrial Cancer." bit.ly/3hLZe8iMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

NEC Releases New iPASOLINK VR4 and 25Gbps Capable iPASOLINK EX Advanced Dual to Support Increased Capacity for 5G Networks

TOKYO, Mar 2, 2022 - (JCN Newswire via SEAPRWire.com) - NEC Corporation (TSE: 6701), a leading provider of wireless solutions, today announced the global release of its new iPASOLINK VR4 for telecommunications providers looking to expand network capacity and also announced the global release of its 25Gbps capable iPASOLINK EX Advanced Dual for optical fiber replacement and flexible deployment planning for leading operators expanding into 5G networks.iPASOLINK VR4 with new MC-AV cardNEC's iPASOLINK microwave and millimeter radio products are well known and trusted for their reliability and performance by operators who require high availability and high-capacity operations across a wide range of network applications and environmental conditions. The new iPASOLINK VR4 includes support for the NEC Multi-Traffic Aggregation (MTA) feature with the ability to achieve a more wide-band interface and higher density implementation. The new iPASOLINK VR4 features a new MC-AV card that comes standard with Adaptive Modulation Radio (AMR) and supports channel widths up to 80 / 112 MHz and 4096 QAM for operators wanting to add higher capacity links and to maintain high availability. The new MC-AV also adds MTA functionality, an advanced wireless aggregation technology that allows milli-meter Wave (mmW) and microwave radio links to be combined to form even higher capacity multiband links. The MTA feature can combine up to 10 channels of microwave and mmW band radio, for a total combined capacity of 10 Gbps. To support the increased radio capacity that the new iPASOLINK VR4 can deliver, NEC has also increased the front panel Ethernet port speeds by adding support for four 10Gbps SFP Ethernet interfaces, making it possible to support the MTA radio capacity and meet the demands of operators who need higher speed ports to address wider and more complex network topologies. The new SFP ports support industry standard 10GBase-SR/LR SFP 10Gbps transceivers. The iPASOLINK EX Advanced Dual E-Band radio now adds support for 25GbE interfaces in a dual transceiver single box solution, lowering the total cost of ownership (TCO) for network operators, simplifying cable management and increasing link capacity and availability for operators. The iPASOLINK EX Advanced Dual's built-in 20Gbps wireless transceiver can be combined with other iPASOLINK products, including split mount and all-outdoor radio equipment using the Multi-Traffic Aggregation function to provide a true 25Gbps radio link. The 25GbE interface ensures that there is no need for a complex LAG interface with multiple cables to deliver traffic to the interconnected network infrastructure. In addition to the capacity increase, NEC has also improved the RF performance of the iPASOLINK EX Advanced Dual, increasing the transmit power by 3dB, to achieve the industry's highest power level. The additional TX power makes it possible to extend the transmission distance and improve availability, which are key issues in E-Band radio applications. As part of the RF improvements NEC has also added support for 1.5 GHz channel-widths making more efficient use of precious spectrum resources and increasing the flexibility of network design. iPASOLINK EX Advanced Dual supports standard Ethernet technology-compliant interfaces, which support both 5G backhaul networks and future 5G fronthaul networks. Moreover, the new iPASOLINK can also be deployed as an alternative to fiber or fiber backup applications for internet service providers (ISP), enterprises, and markets for municipalities, universities, schools and hospitals (MUSH). "NEC will continue to provide innovative products that meet the needs of our customers. An important factor in 5G networks that are now being implemented is to provide high-density, simple and fast transport," said Yukio Hioki, General Manager, Wireless Solutions Division, NEC Corporation. "In addition, in order to aggregate radios of various bands and realize flexible channel arrangement, it is important that many band options are available and that the optimum radio-head can be selected. NEC is pleased that this not only avoids excessive capital investment, but also reduces unnecessary waste, reduces the environmental burden, and contributes to the sustainable activities of our customers."Note:The iPASOLINK EX Advanced Dual part of this press release is based on results obtained from a project commissioned by the New Energy and Industrial Technology Development Organization (NEDO).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. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Shonan Kamakura Advanced Medical Center Begins Treatment with Hitachi’s First Dedicated Compact Proton Therapy System

TOKYO, Feb 2, 2022 - (JCN Newswire via SEAPRWire.com) - Hitachi, Ltd. (TSE: 6501) has announced that "Shonan Kamakura Advanced Medical Center" at Shonan Kamakura General Hospital of Tokushukai Medical Group, where Hitachi's compact proton therapy system (hereafter, "the system") has been installed, has commenced treatment with the system on 31 January 2022. This is the first order for Hitachi's dedicated compact proton therapy system.Proton Therapy SystemShonan Kamakura Advanced Medical Center is a medical facility providing comprehensive cancer treatment, including advanced radiotherapy, built adjacent to the site of Shonan Kamakura General Hospital by Tokushukai Group Medical Corporation, which operates approximately 400 medical facilities and nursing homes throughout Japan. Until now, there have been no proton therapy facilities in Kanagawa Prefecture, where the center is located, but the compact proton therapy system, with its reduced footprint, makes it possible to install a proton therapy facility on a limited site close to the city center.Features of the installed systemIn response to the growing worldwide demand for smaller proton therapy systems, Hitachi has developed the proton therapy system, which is specifically designed for a single treatment room. The system is a compact proton therapy system which, by optimizing the layout of the machine, reduces the installation area to about 70% of that of conventional solutions, making it possible to install the system on a limited site in an urban area and reducing the cost and time involved in its installation. It is equipped with advanced technologies such as spot scanning irradiation technology, which allows the proton beam to be delivered according to the shape of the cancer, a 360degree rotating gantry with cone-beam CT(1) for high-precision positioning, and Real-time image Gated Proton Therapy (RGPT)(2), making it both compact and highly functional.Hitachi is committed to accelerating the global development of particle therapy system and contributing to cancer treatment around the world, as well as to further expanding its healthcare services.(1) Cone beam CT provides three-dimensional anatomical images of patients, at isocenter immediately prior to being treated. Information on the location of bone is obtained from traditional orthogonal x-rays and the motion of tumors is captured by RGPT. These are then combined with the ability to identify healthy tissue surrounding a tumor, particularly the location and shape of soft tissue, via Cone beam CT.(2) RGPT allows real-time beam irradiation to the tumor while compensating for movement associated with respiration. This technology was collaboratively developed between Hokkaido University and Hitachi, and supported by the Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST) of the Japan Society for the Promotion of Science.Overview of Particle TherapyParticle Therapy is an advanced type of cancer radiotherapy. Protons extracted from hydrogen atoms, or carbon ions are accelerated up to 70% of the speed of light. This energy is concentrated directly on the tumor while minimizing radiation dose to surrounding healthy tissue. Particle therapy improves the quality of life for cancer patients since the patient experiences no pain during treatment and the procedure has very few side effects compared to that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment.About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company's website at https://www.hitachi.com. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai: Lenvima (Lenvatinib) in Combination with Keytruda (Pembrolizumab) Approved in Taiwan for the First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

TOKYO, Jan 31, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia.The approval is based on results from the CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination for the first-line treatment of patients with advanced RCC. These results were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.(1) In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the primary efficacy outcome measure of progression-free survival (PFS), as well as the key secondary efficacy outcome measures of overall survival (OS) and objective response rate (ORR) versus sunitinib. For PFS, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; pWorldwide, it is estimated there were more than 430,000 new cases of kidney cancer diagnosed and more than 180,000 deaths from the disease in 2020.(3) In Taiwan, there were more than 1,400 new cases and more than 600 deaths in 2018.(4) Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC.(5) Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases.(6) Approximately 30% of patients with RCC will have metastatic disease at diagnosistreatment for localized RCC.(7),(8). The prognosis for these patients is poor as survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 12% for patients diagnosed with metastatic disease.(8)Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals. *In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A.About LENVIMA (lenvatinib mesylate)LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.About CLEAR/KEYNOTE-581 TrialThe approval was based on data from the CLEAR (Study 307)/KEYNOTE-581 trial (ClinicalTrials.gov, NCT02811861), a Phase 3, multicenter, open-label, randomized trial conducted in 1,069 patients with advanced RCC with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting. Patients were enrolled regardless of PD-L1 tumor expression status. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Randomization was stratified by geographic region (North America and Western Europe vs. "Rest of the World") and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favorable vs. intermediate vs. poor). The primary efficacy outcome measure was PFS based on Blinded Independent Central Review (BICR) using RECIST 1.1, and PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumor expression status. Key secondary efficacy outcome measures were OS and ORR. Patients were randomized 1:1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). Treatment continued until unacceptable toxicity or disease progression as determined by investigator and confirmed by BICR using RECIST 1.1. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. KEYTRUDA was continued for a maximum of 24 months; however, treatment with LENVIMA could be continued beyond 24 months. Assessment of tumor status was performed at baseline and then every eight weeks.About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co- commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.In Taiwan, Eisai's pharmaceutical sales subsidiary Eisai Taiwan Inc. is marketing Lenvima and is co-commercializing it with a local branch of Merck & Co., Inc., Kenilworth, N.J., U.S.A.(1) Motzer R. et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. The New England Journal of Medicine.(2) The information listed in Taiwanese Package insert(3) International Agency for Research on Cancer, World Health Organization. "Kidney Fact Sheet." Cancer Today, 2020. bit.ly/3D0XjVA(4) Taiwan Cancer Registry Report.(5) American Cancer Society. Key Statistics About Kidney Cancer, bit.ly/3xwCY9i.(6) Padala, S. A., Barsouk, A., Thandra, K. C., Saginala, K., Mohammed, A., Vakiti, A., Rawla, P., & Barsouk, A. (2020). Epidemiology of Renal Cell Carcinoma. World Journal of Oncology, 11(3), 79-87. https://doi.org/10.14740/wjon1279.(7) Thomas A. Z. et al. The Role Of Metastasectomy In Patients With Renal Cell Carcinoma With Sarcomatoid Dedifferentiation: A Matched Controlled Analysis. The Journal of Urology. 2016 Sep; 196(3): 678-684. bit.ly/3obtpcF(8) Shinder B. et al. Surgical Management of Advanced and Metastatic Renal Cell Carcinoma: A Multidisciplinary Approach. Frontiers in Oncology. 2017; 7: 107. bit.ly/3IPFonTMedia Inquiries:Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Eisai: Results From Pivotal Phase 3 Study 309/KEYNOTE-775 Trial of LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Advanced Endometrial Carcinoma

TOKYO, Jan 20, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine. The pivotal study evaluated the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting.The publication includes previously reported data that was first presented in an oral plenary session at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer.(1) Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Objective response rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication."While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients.""The Phase 3 Study 309/KEYNOTE-775 trial demonstrates the ongoing commitment that Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the LENVIMA plus KEYTRUDA combination."The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which LENVIMA plus KEYTRUDA is not approved in the U.S.Based on the results from the Phase 3 Study 309/KEYNOTE-775 trial, LENVIMA plus KEYTRUDA has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. LENVIMA plus KEYTRUDA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.(1) Eisai co., Ltd. Home page. "LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study". https://www.eisai.com/news/2021/news202116.htmlEisai Co., Ltd.Public Relations:+81-(0)3-3817-5120Investor Relations:+81-(0) 70-8688-9685Merck & Co., Inc., Kenilworth, N.J., U.S.A.Media RelationsMelissa Moody: +1-(215) 407-3536Nikki Sullivan: +1-(718) 644-0730Investor RelationsPeter Dannenbaum: +1- (908) 740-1037Raychel Kruper: +1-(908) 740- 2107For more information, visit https://www.eisai.com/news/2022/news202207.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Tiny electric generators could accelerate wound healing

TSUKUBA, Japan, Jan 18, 2022 - (ACN Newswire via SEAPRWire.com) - Tiny dressings that generate electricity in response to movement could accelerate wound healing and tissue regeneration. Scientists in Taiwan reviewed the latest advances and potential applications of wound healing technology in the journal Science and Technology of Advanced Materials."Piezoelectric and triboelectric nanogenerators are excellent candidates for self-assisted wound healing due to their light weight, flexibility, elasticity and biocompatibility," says bioengineer Zong-Hong Lin of the National Tsing Hua University in Taiwan.The natural wound healing process involves complex interactions between ions, cells, blood vessels, genes and the immune system; with every player triggered by a sequence of molecular events. An integral part of this process involves the generation of a weak electric field by the damaged epithelium - the layer of cells covering tissue. The electric field forms as a result of an ion gradient in the wound bed, which plays an important role in directing cell migration and promoting blood vessel formation in the area.Scientists discovered in the mid- to late-1900s that stimulating tissue with an electric field could improve wound healing. Current research in this field is now focused on developing small, wearable, and inexpensive patches that aren't encumbered by external electrical equipment.This has led to research on piezoelectric materials, including natural materials like crystals, silk, wood, bone, hair and rubber, and synthetic materials such as quartz analogs, ceramics and polymers. These materials generate an electric current when exposed to mechanical stress. Nanogenerators developed using the synthetic materials are especially promising.For example, some research teams are exploring the use of self-powered piezoelectric nanogenerators made with zinc oxide nanorods on a polydimethylsiloxane matrix for accelerating wound healing. Zinc oxide has the advantage of being piezoelectric and biocompatible. Other scientists are using scaffolds made from polyurethane and polyvinylidene fluoride (PVDF) due to their high piezoelectricity, chemical stability, ease of manufacturing and biocompatibility. These and other piezoelectric nanogenerators have shown promising results in laboratory and animal studies.Another type of device, called a triboelectric nanogenerator (TENG), produces an electric current when two interfacing materials come into and out of contact with each other. Scientists have experimented with TENGs that generate electricity from breathing movements, for example, to accelerate wound healing in rats. They have also loaded TENG patches with antibiotics to facilitate wound healing by also treating localized infection."Piezoelectric and triboelectric nanogenerators are excellent candidates for self-assisted wound healing due to their light weight, flexibility, elasticity and biocompatibility," says bioengineer Zong-Hong Lin of the National Tsing Hua University in Taiwan. "But there are still several bottlenecks to their clinical application."For example, they still need to be customized so they are fit-for-size, as wound dimensions vary widely. They also need to be firmly attached without being negatively affected or corroded by the fluids that naturally exude from wounds."Our future aim is to develop cost-effective and highly efficient wound dressing systems for practical clinical applications," says Lin.Further informationZong-Hong LinNational Tsing Hua UniversityEmail: linzh@mx.nthu.edu.twResearch paper: https://www.tandfonline.com/doi/full/10.1080/14686996.2021.2015249About Science and Technology of Advanced Materials (STAM)Open access journal STAM publishes outstanding research articles across all aspects of materials science, including functional and structural materials, theoretical analyses, and properties of materials. https://www.tandfonline.com/STAMDr. Yoshikazu ShinoharaSTAM Publishing DirectorEmail: SHINOHARA.Yoshikazu@nims.go.jpPress release distributed by Asia Research News for Science and Technology of Advanced Materials. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

TOKYO and KENILWORTH, N.J., Nov 29, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p "This approval is welcome news for patients in Europe, and is based on the first Phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "Regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in KEYTRUDA plus LENVIMA that demonstrated a 38% reduction in risk of death compared to chemotherapy alone." "Until recently, women in Europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options," said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The approval of LENVIMA plus KEYTRUDA in this setting reflects the progress that we have made in our collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. in developing solutions for those diagnosed with difficult-to-treat cancers. We thank the patients, families and healthcare providers who made this milestone possible." In the Study 309 trial, the most common adverse reactions of these patients (>/=20%) for LENVIMA plus KEYTRUDA* were hypertension (63%), diarrhoea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), decreased weight (35%), arthralgia (33%), proteinuria (29%), constipation (27%), headache (27%), urinary tract infection (27%), dysphonia (25%), abdominal pain (23%), asthenia (23%), palmar-plantar erythrodysaesthesia syndrome (23%), stomatitis (23%), anaemia (22%), and hypomagnesaemia (20%). This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA is now approved by the European Commission for two different types of cancer: for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation and for the first-line treatment of adult patients with advanced renal cell carcinoma. *According to the information listed in the SmPC (Summary of Product Characteristics)For more information, visit https://www.eisai.com/news/2021/news202193.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma

TOKYO and KENILWORTH, N.J., Nov 29, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA (KISPLYX in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus, KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the first-line treatment of adult patients with advanced RCC.The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32- 0.49]; p"A key focus of our collaboration with Eisai is to advance our clinical development program to evaluate the potential of KEYTRUDA plus LENVIMA to improve responses across different types of cancer, including renal cell carcinoma," said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "Today's approval of KEYTRUDA plus LENVIMA brings a new treatment option to patients with advanced renal cell carcinoma in Europe, and further validates our efforts to research this promising combination of an immunotherapy and tyrosine kinase inhibitor for some of the most difficult-to- treat cancers.""Renal cell carcinoma is the most common type of kidney cancer in both men and women, marking the significance of the European approval for the LENVIMA plus KEYTRUDA combination," said Corina Dutcus, M.D., Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "We remain committed to continuing to explore this combination therapy with the goal of improving care for people living with cancer. The participation of many patients, families and healthcare providers made this approval possible, for which we are very grateful."In the CLEAR/KEYNOTE-581 trial, the most common adverse reactions (≥30%) for LENVIMA plus KEYTRUDA* were diarrhoea (61.8%), hypertension (51.5%) fatigue (47.1%), hypothyroidism (45.1%), decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%), and arthralgia (32.4%).This approval allows marketing of LENVIMA plus KEYTRUDA in all 27 EU member states plus Iceland, Liechtenstein, Norway and Northern Ireland. LENVIMA plus KEYTRUDA is now approved by the European Commission for two different types of cancer: for the first-line treatment of adult patients with advanced renal cell carcinoma and for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum- containing therapy in any setting and who are not candidates for curative surgery or radiation. *According to the information listed in the SmPC (Summary of Product Characteristics)About CLEAR/KEYNOTE-581 TrialThe approval was based on data from the CLEAR(Study 307)/KEYNOTE-581 trial (ClinicalTrials.gov, NCT02811861), a Phase 3, multicenter, open-label, randomized trial conducted in 1,069 patients with advanced RCC with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting. Patients were enrolled regardless of PD-L1 tumor expression status. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Randomization was stratified by geographic region (North America and Western Europe vs. "Rest of the World") and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favorable vs. intermediate vs. poor). The primary efficacy outcome measure was PFS based on Blinded Independent Central Review (BICR) using RECIST 1.1, and PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumor expression status. Key secondary efficacy outcome measures were OS and ORR.Patients were randomized 1:1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). Treatment continued until unacceptable toxicity or disease progression as determined by investigator and confirmed by BICR using RECIST 1.1. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. KEYTRUDA was continued for a maximum of 24 months; however, treatment with LENVIMA could be continued beyond 24 months. Assessment of tumor status was performed at baseline and then every eight weeks.About Renal Cell Carcinoma (RCC)1,2,3,4,5,6Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In Japan, there were more than 25,000 new cases and 8,000 deaths in 2020. In Europe, it is estimated there were more than 138,000 new cases of kidney cancer diagnosed and more than 54,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis. Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients diagnosed with metastatic disease.About LENVIMA (lenvatinib); available as 10mg and 4mg capsulesLENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRalpha), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti- angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it is approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.About KEYTRUDA (pembrolizumab) Injection, 100mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry's largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.Eisai's Focus on CancerEisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.About EisaiEisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society's toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s Focus on CancerOur goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Kenilworth, N.J., U.S.A., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.About Merck & Co., Inc., Kenilworth, N.J., U.S.A.For over 130 years, Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Kenilworth, N.J., U.S.A. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases - as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USAThis news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2020 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).(1) International Agency for Research on Cancer, World Health Organization. "Kidney Fact Sheet." Cancer Today, 2020. bit.ly/3D0XjVA.(2) International Agency for Research on Cancer, World Health Organization. "Japan Fact Sheet." Cancer Today, 2020. bit.ly/32LnzH7 .(3) American Cancer Society. Key Statistics About Kidney Cancer. bit.ly/3xwCY9i.(4) Seattle Cancer Care Alliance. "Kidney Cancer Fact." bit.ly/3o1PIBL(5) Richard E. et al. Renal Cell Carcinoma: Diagnosis and Management. American Family Physician. 2019 Feb 1;99(3):179-184. bit.ly/3FPRZG4 (6) Cancer. Net. "Statistics, 2021." Kidney cancer. bit.ly/3riwN7S Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)