Artificial Intelligence
Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation
Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease¹; more than 147,000 breast cancer patients in Europe die annually from the disease²If approved by the European Commission, ORSERDU would be the first and only treatment specifically indicated for patients with ER+, HER2- advanced or metastatic breast cancer tumors that harbor ESR1 mutationsESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers, and are a known driver of resistance to standard endocrine therapy, making these tumors more difficult to treatFLORENCE, Italy and NEW YORK, July 21, 2023 /PRNewswire/ — The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ORSERDU® (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)–positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, Stemline and its affiliates will commercialize the product within Europe. ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations. ESR1 mutations are acquired mutations that develop as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
“Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options. ORSERDU may become the first product, if approved by the European Commission, indicated in ER+, HER2- advanced breast cancer with ESR1 mutations, which are a strong driver of resistance to treatment in up to 40% of patients in second line mBC. ORSERDU, if approved, will also provide a convenient daily oral treatment,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of today’s positive CHMP opinion as it reflects our commitment to developing innovative solutions that address the greatest unmet needs in cancer treatment, and brings us one step closer to providing an important new option to the patients and families impacted by ESR1-mutated, ER+, HER2- metastatic breast cancer.”
The positive CHMP opinion for ORSERDU is supported by data from the Phase 3 EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with elacestrant versus standard-of-care (SOC), defined as investigator’s choice of an approved endocrine monotherapy. The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
A post hoc subgroup analysis of the EMERALD PFS results, which were presented at the San Antonio Breast Cancer Symposium (SABCS) 2022, demonstrated that the duration of prior CDK4/6i treatment was positively associated with longer PFS on elacestrant but not with SOC. For patients with ESR1 mutations who were treated with CDK4/6i for ≥12 months prior to randomization on EMERALD, elacestrant achieved a median PFS of 8.6 months versus 1.9 months on SOC, with a 59% reduction in the risk of progression or death (HR=0.41 95% CI: 0.26-0.63).³
“As an oncologist, it is remarkable that we are on the cusp of having the first treatment option for patients with advanced or metastatic ER+, HER2- breast cancer harboring ESR1 mutations, which occur in up to 40% of patients in the metastatic setting,” said Giuseppe Curigliano, MD, PhD, Professor of Medical Oncology at the University of Milano and the Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy. “Elacestrant has demonstrated efficacy and a manageable safety profile, underscoring the potential benefit this therapy may soon bring to the patients we care for, and to the broader oncology community.”
Safety data were consistent with previously reported results. Serious adverse reactions reported in ≥ 1% of patients included nausea, dyspnoea, and thromboembolism (venous). The most common (≥ 10%) adverse reactions with ORSERDU were nausea, triglycerides increased, cholesterol increased, vomiting, fatigue, dyspepsia, diarrhoea, calcium decreased, back pain, creatinine increased, arthralgia, sodium decreased, constipation, headache, hot flush, abdominal pain, anaemia, potassium decreased, and alanine aminotransferase increased. The most common Grade ≥3 (≥2%) adverse reactions of elacestrant were nausea (2.7%), AST increased (2.7%), ALT increased (2.3%), anaemia (2%), back pain (2%), and bone pain (2%).
About the EMERALD Phase 3 Study (NCT03778931)
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC.
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.
The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc. The Menarini Group is now fully responsible for global registration, commercialization, and further development activities for elacestrant.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. (“Stemline”) a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the United States, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes Nexpovio® in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.
¹ Decision Resource Group / Clarivate Breast Cancer Landscape / Epidemiology – June 14, 2023
² International Agency for Research on Cancer, World Health Organization – Globocan – 2020
³ Bardia et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022. GS3-01
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Artificial Intelligence
HKPC and HP Launch Joint Technology Centre in Hong Kong on Advanced 3D Printing
HONG KONG, May 7, 2024 /PRNewswire/ — Hong Kong Productivity Council (HKPC) and HP signed a collaboration agreement (agreement) today to establish the HKPC-HP 3D Printing Technology Centre (Centre) in Hong Kong for application research development on additive manufacturing, also known as 3D printing. The Centre aims to become a pilot transformation base, applying advanced 3D printing technologies to empower various industries, sharpen their competitive edge, and foster the development of high-value strategic industrial chains. It will also accelerate Hong Kong’s pioneering effort in micro-factory and new industrialisation development, offering important references and inspiration worldwide in the pursuit of innovative and sustainable development.
The Centre will be located in the HKPC Building, being the first in Asia to be equipped with both HP’s research version of “Metal Jet” and “Multi Jet Fusion” industrial 3D printers. HP will bring advanced equipment and talent to support the operations of the Centre, and HKPC will contribute expertise in raw material development, process development, and smartification. Market research data estimate that the value of the 3D printing industry will reach US$186.4 billion by 2033, a significant increase from US$27.7 billion in 2023, indicating the immense market potential.
Clean, digitally powered 3D printing generates minimal waste and a minimal carbon footprint. This aligns with global goals of achieving green and sustainable development, while also promoting long-term economic growth through sustainable industries. At the same time, advanced 3D printing provides significant opportunities in strategic industries, such as healthtech, critical components, electronics, and more. In the future, the Centre, with its focus on customisation and precision, can be a game-changer in meeting the demand for hard-to-source parts, complex structures, patient-specific implants, and other tools. This will enable enterprises, especially small and medium enterprises (SMEs), to leverage advanced 3D printing technology and produce high-value, customised goods that can respond to market-specific demands in real-time, offering new levels of flexibility and efficiency that conventional factories are unable to meet.
In the ceremony, Professor Dong SUN, JP, Secretary for Innovation, Technology and Industry, HKSAR Government, said, “3D printing enables the development of more micro-factories in Hong Kong. Compared to the traditional one, micro-factories require less land and materials, generate higher efficiency but less waste. This best suits Hong Kong’s condition, where land resources are limited and labour costs are relatively high. The establishment of this 3D printing technology centre is undoubtedly a good answer to show how we make use of state-of-the-art technology to promote advanced manufacturing and new industrialisation in Hong Kong. I am confident that Hong Kong’s manufacturing industry will reach new heights, and ‘Made in Hong Kong’ will continue to be a reputable and brilliant international brand. I look forward to more representative technology companies from all around the globe, such as HP to team up with our I&T quangoes, such as HKPC, bringing talents, technologies and machinery to Hong Kong to redefine Hong Kong’s manufacturing industry and drive high-quality economic growth.”
Hon Sunny TAN, Chairman of HKPC, said, “We’re very pleased to form this research collaboration with HP, underscoring the confidence that global technology firms have in Hong Kong’s strengths in innovation. As an international innovation and technology centre, Hong Kong can be a paragon of the micro-factory city of the future that provides Hong Kong’s answer to develop new productive forces and set a fine example in Asia and across the globe to pursue innovation-driven, sustainable development. Hong Kong’s unique conditions make it particularly suitable for the development of micro-factories. The vibrant ecosystem in Hong Kong, combined with the robust supply chains in the Guangdong-Hong Kong-Macao Greater Bay Area, will provide an excellent pilot transformation base for the development of micro-factories, with significant implications for economies in Asia and worldwide.”
Mr Ramon PASTOR, Global Head of 3D Metals at HP Personalisation & 3D Printing, said, “It’s truly exciting to witness the launch of this collaborative effort between HKPC and HP, which aligns perfectly with our vision of leveraging Additive Manufacturing to drive industrialisation. This initiative not only showcases our dedication to technological advancement but also our shared vision for propelling industry innovation forward. HP believes in the immense potential of Hong Kong’s technology sector. We are also glad to bring in Pro-Technic Machinery Ltd. (Pro-Technic) to provide local support for our collaboration with HKPC.”
The Centre is planned to open in September, serving as a networking hub to promote closer collaboration among academia, research institutions and industries, empowering diverse sectors to grasp market trends. In addition to application development, the Centre will also provide consultancy and training services, driving advancements and propelling the 3D printing industry, as well as other industries utilising 3D printing technologies, forward.
About Hong Kong Productivity Council
The Hong Kong Productivity Council (HKPC) is a multi-disciplinary organisation established by statute in 1967, to promote productivity excellence through relentless drive of world-class advanced technologies and innovative service offerings to support Hong Kong enterprises. Being a key enabler of Industry 4.0 and Enterprise 4.0, HKPC strives to facilitate new industrialisation in Hong Kong, as well as bolstering Hong Kong to be an international innovation and technology centre and a smart city. The Council offers comprehensive innovative solutions for Hong Kong industries and enterprises, enabling them to achieve resources and productivity utilisation, effectiveness and cost reduction, and enhance competitiveness in both local and overseas marketplace. The Council partners and collaborates with local industries and enterprises and world-class R&D institutes to develop applied technology solutions for value creation. It also benefits a variety of sectors through product innovation, technology transfer, and commercialisation, bringing enormous business opportunities ahead. HKPC’s world-class R&D achievements have been widely recognised over the years, winning an array of local and overseas accolades.
In addition, HKPC offers SMEs and startups immediate and timely assistance in coping with the ever-changing business environment, and strengthens talent nurturing and Hong Kong’s competitiveness with FutureSkills training for enterprises and academia to enhance digital capabilities and TechEd competencies.
For more information, please visit HKPC’s website: www.hkpc.org/en.
About HP
HP Inc. (NYSE: HPQ) is a global technology leader and creator of solutions that enable people to bring their ideas to life and connect to the things that matter most. Operating in more than 170 countries, HP delivers a wide range of innovative and sustainable devices, services and subscriptions for personal computing, printing, 3D printing, hybrid work, gaming, and more. For more information, please visit: http://www.hp.com.
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Artificial Intelligence
ShipFlex from Locus Expands Global Carrier Network to Over 160 Carriers, Enhancing Multi-Carrier Parcel Management Capabilities
SAN FRANCISCO, May 7, 2024 /PRNewswire/ — Locus.sh, a global AI-powered integrated logistics management SaaS company, announced its global carrier network for ShipFlex (its innovative multi-carrier parcel management solution) now has over 160 carriers. This significant expansion reflects ShipFlex’s continued commitment to redefining flexibility and efficiency in logistics for shippers globally.
“By efficiently broadening our carrier network globally, ShipFlex stands out as a marketing-leading offering that has the agility to cater to shippers’ fulfillment needs across diverse geographies, industries, fulfillment models, and fleet types, among other variables crucial to shippers,” said Nishith Rastogi, Founder and CEO of Locus.
For retail, manufacturing, and consumer packaged goods (CPG) companies that outsource their deliveries, ShipFlex stands out as a powerful ally as it optimizes fulfilmment operations across captive, contracted, outsourced and even hybrid fleets. “These sectors prize end-to-end optimization of operations and costs to deliver exemplary customer experiences. By automating decision-making around selecting third-party delivery providers, ShipFlex empowers shippers to meet both current and future demands efficiently across diverse fleet types used by these industries,” added Rastogi.
ShipFlex automates multi-carrier deliveries tailored to specific business constraints regarding cost, speed, and efficiency. The platform simplifies the logistics of sourcing additional capacity and assigning shipments, all from a single dashboard.
The solution enhances dispatch flexibility with its capacity to integrate various carriers easily. It provides end-to-end visibility of the order journey, including real-time status updates and customer notifications, ensuring a top-notch post-purchase experience and minimizing delivery re-attempts.
About Locus
Locus’ order-to-delivery AI-powered dispatch and transport management software helps enterprises transform their logistics from cost centers to revenue generators through advanced optimization algorithms and intuitive workflow automation. Backed by GIC Singapore, Tiger Global, and Qualcomm Ventures, it has helped 200+ global customers across industries – Unilever, Nestle, BlueDart-DHL, etc. – execute over 1 billion deliveries across USA, Southeast Asia, the Middle East, and the Indian subcontinent.
www.locus.sh
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Artificial Intelligence
Metacon and Siemens enter into collaboration for the manufacture of systems for green hydrogen production
STOCKHOLM, May 7, 2024 /PRNewswire/ — Metacon AB (publ) and Siemens AB have signed a Memorandum of Understanding to enter into a partnership with the aim of accelerating the manufacturing of hydrogen production systems in Sweden, for the European market.
At the beginning of the year, Metacon announced that the company has been granted exclusive rights for the manufacture of complete electrolysis plants based on the partner PERIC’s world-leading technology for pressurized alkaline electrolysis modules (stacks). One of the key components of PERIC’s alkaline technology is efficient and proven 5 MW modules with over 10 years of operating data. Metacon also has access to the 10 MW module that PERIC recently launched and which today, in terms of power and production, is one of the world’s largest. The rights apply to most European countries and mean that Metacon can start from a proven technology that has been developed and refined for over 60 years, and make the adaptations required to match the requirements for safety and automation found in European standards for hydrogen production. With the exclusive right, Metacon now aims to become one of the market leaders in Europe for this type of large-scale hydrogen plants.
The joint MoU means that Siemens will become a technology partner to Metacon to contribute with its solid experience in delivering products, solutions and services in automation, power distribution, electrification, instrumentation, building technology and drives. Siemens will also be able to contribute with its wide range of digital services and software for optimisation, standardisation and simulation during both the manufacturing and operational phases of hydrogen plants.
“Hydrogen is an important piece of the puzzle in the industrial, energy and transport sectors to become CO2 neutral, and is the focus of Siemens’ global investment in Power-to-X. The partnership with Metacon marks a milestone in our quest to create a more sustainable world by, among other things, developing innovative solutions for the energy sector,” says Mikael Kraft, Head of Factory Automation and Sales at Siemens Digital Industries.
“Metacon has big plans for the investment in the manufacture and sale of large-scale electrolysis plants to, among others, the basic industry, the wind power sector and the transport sector in Europe. I have a hard time imagining a better partner on such a journey than Siemens. With its world-leading portfolio of technology, expertise and long-standing experience of similar projects, this partnership gives us the opportunity to both accelerate and optimize central parts of our unique Gigafactory project,” says Christer Wikner, CEO and President, Metacon.
For further information, please contact Christer Wikner, by phone 0707-647389 or e-mail [email protected]
About Metacon
Metacon AB (publ) develops and manufactures energy systems for the production of fossil-free “green” hydrogen. The products in the Reforming business area are based, among other things, on a patented technology that generates hydrogen through so-called catalytic steam reforming of biogas or other hydrocarbons. The development of Metacon’s reforming products is done within the wholly owned subsidiary Metacon S.A in Patras, Greece. The business is focused on catalytic process chemistry and advanced reformers for high-efficiency hydrogen production.
Metacon also offers complete electrolysis plants and integrated refueling stations for green hydrogen, a large and globally growing area for the production of green hydrogen. Electrolysis is a process of driving a chemical reaction to split water by adding electricity. If the electricity used is non-fossil, the hydrogen will also be fossil-free and climate-neutral. Green hydrogen can be used in sectors such as transport, basic industry and the real estate sector, with a better environment and climate as a result. www.metacon.com
About Siemens
Siemens AG (Berlin and Munich) is a technology company with a focus on industry, infrastructure, transport and healthcare. From more resource-efficient factories, resilient supply chains, and smarter buildings and grids, to cleaner and more convenient transportation and advanced healthcare, the company is developing technologies to create real value for customers and users. By combining the real and digital worlds, Siemens empowers its customers to transform their businesses and markets, helping them transform the lives of billions of people. Siemens owns a majority stake in the listed company Siemens Healthineers, a global leading medical device provider that is shaping the future of healthcare.
In the 2023 financial year ended September 30, 2023, the Siemens Group generated revenues of €77.8 billion and net profit of €8.5 billion. As of September 30, 2023, the company had approximately 320,000 employees worldwide. During the same period, Siemens in Sweden generated revenues of SEK 6.9 billion and employed approximately 1,500 people. For more information, see www.siemens.com and www.siemens.se.
For more information see:www.metacon.com | X: @Metaconab | LinkedIn: www.linkedin.com/company/metaconab
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