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
Bitrue expands Bitcoin Runes Offerings with GPTV Listing and Staking Options
VICTORIA, Seychelles, May 3, 2024 /PRNewswire/ — Leading digital asset exchange Bitrue continues its community-driven approach with the listing of a new Bitcoin Runes token, GPTV•AI•PEPE•KING (GPTV). This follows the recent addition of several other Bitcoin Runes tokens to the platform, including SATOSHI•NAKAMOTO (SATOSHI), LOBO•THE•WOLF•PUP (LOBO), RSIC•GENESIS•RUNE (RSIC), and DOG•GO•TO•THE•MOON (DOG). Trading for the GPTV/USDT pair commenced on April 30th, 2024.
What is GPTV?
GPTV is the native token of AI PEPE KING, a project claiming to be the “largest AI Meme Community” with a presence on both the Polygon (AIPEPE) and Bitcoin Runes (GPTV) blockchains. Notably, AI PEPE KING secured a $10 million investment to develop AI-powered customer service tools leveraging the ChatGPT technology. Additionally, they are building a “Dream Lottery” system. Revenue generated from these products is earmarked for buybacks and burns of both AIPEPE and GPTV tokens, potentially influencing their long-term value.
Staking Opportunities with Attractive Yields
Bitrue is also offering users staking opportunities for those holding BTR, AIPEPE, RSIC, or DOG tokens. By staking their holdings, users can earn rewards in GPTV, with estimated annual percentage yield (APY) varying on the staked token, with BTR offering 22.15%, AIPEPE at 23.18%, RSIC boasting a higher 31.37%, and DOG coming in at 23.62%. These yields present a potentially lucrative opportunity for users to grow their cryptocurrency holdings, but also come with financial risk and the potential for investment to return much lower yields.
Bitrue’s Focus on Community Engagement
The listing of these Bitcoin Runes tokens is a testament to Bitrue’s commitment to its user base. The decision to add these tokens stemmed from a community poll conducted through an X poll on Bitrue’s X account. This highlights the exchange’s dedication to incorporating community feedback into its decision-making process, fostering a sense of collaboration and shared interest.
With the addition of GPTV and the introduction of staking opportunities, Bitrue continues to expand its offerings for users interested in the burgeoning world of Bitcoin Runes tokens. The exchange’s focus on community engagement further strengthens its position as a platform that prioritizes user input and satisfaction.
About Bitrue
Launched in July 2018, Bitrue is a diversified digital asset exchange that supports trading, loans and investments. Bitrue aims to utilize blockchain technology to bring financial opportunities to everybody regardless of their location or financial position. With offices in Asia and Europe, the business continues to develop new features at a rapid speed to fully service the new wave of the digital economy. More information is available at Bitrue’s website.
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Artificial Intelligence
5G Enterprise Market Projected to Reach $115.81 billion by 2030 – Exclusive Report by 360iResearch
PUNE, India, May 2, 2024 /PRNewswire/ — The report titled “5G Enterprise Market by Equipment (Distributed Antenna System, Radio Node, Service Node), Organization Size (Large Enterprises, SMEs), End User – Global Forecast 2024-2030” is now available on 360iResearch.com’s offering, presents an analysis indicating that the market projected to grow from a size of $17.30 billion in 2023 to reach $115.81 billion by 2030, at a CAGR of 31.20% over the forecast period.
“The Pivotal Role of 5G Technology in Enterprise Evolution”
The advent of 5G technology marks a transformative era for businesses worldwide, offering exceptional speed, reduced latency, and enhanced connectivity that promise to elevate operational efficiency and digital innovation across various sectors. From enabling precise real-time monitoring and predictive maintenance in manufacturing to advancing telemedicine and seamless data collaborations in healthcare, 5G stands as a cornerstone for future advancements. Its pivotal role is revolutionizing transportation by supporting autonomous vehicles and smart infrastructure, significantly elevating safety and efficiency. The surge in 5G enterprise adoption is fueled by the growing need for robust and swift network connections to accommodate an increasing array of Internet of Things (IoT) devices and applications. Challenges include the substantial upfront costs associated with 5G infrastructure and concerns over data security. The potential for 5G to spur innovation is immense, mainly through the development of 5G-as-a-Service (5GaaS) and its synergy with cutting-edge technologies such as edge computing and artificial intelligence. Regionally, North America is major in adoption, supported by significant telecom investments, while the European Union’s concerted efforts bolster 5G integration across industries. The Middle East’s ambitions to become a significant region globally in 5G through smart city and industrial automation investments distinguish it. In contrast, the APAC region’s rapid growth is supported by early adoption and extensive government support, particularly in South Korea, China, and Japan. Thus, 5G is set to redefine enterprise operations, driving innovation and enabling smart solutions globally, heralding a new chapter in digital transformation for industries worldwide.
Download Sample Report @ https://www.360iresearch.com/library/intelligence/5g-enterprise
“5G’s Role in Advancing Industry 4.0 and Digital Innovations”
In today’s fast-evolving digital age, the seamless integration of cutting-edge technologies such as artificial intelligence (AI), the Internet of Things (IoT), and blockchain into everyday business operations is becoming increasingly crucial. This integration is driving a significant surge in the need for uninterrupted, high-speed network coverage across various sectors. As technologies become more affordable and their performance enhanced, their adoption in both private and public sectors is witnessing a remarkable increase, paving the way for innovative payment solutions and digital currencies. This transformation reshapes diverse commercial landscapes, including entertainment, journalism, advertising, and retail. Consequently, the demand for 5G connectivity is escalating, recognized for its capability to deliver speeds of 15 to 20 Gbps, connect a vast array of devices, and facilitate the creation of virtual networks tailored to specific needs. Moreover, as Industry 4.0 propels manufacturing into the digital era with its emphasis on automation and digital technologies, the role of 5G in supporting these advancements becomes indispensable. By enabling faster connectivity for AI, data analytics, IoT, blockchain, and machine learning applications, 5G is at the forefront of improving operational efficiency and flexibility in the manufacturing sector, setting the stage for the exponential growth of the 5G enterprise market.
“The Integral Role of Radio Nodes, DAS, and Service Nodes in Enhancing 5G Networks”
In the rapidly evolving world of 5G networks, the harmonious functioning of radio nodes, distributed antenna systems (DAS), and service nodes plays a pivotal role in ensuring uninterrupted, high-speed connectivity across diverse environments. Radio nodes, vital for facilitating direct communication between devices, including smartphones and tablets, ensure the seamless execution of critical radio functions such as modulation and demodulation. They shine especially in areas where a robust, reliable connection is paramount, catering to the needs of densely populated zones. DAS is used in complexes such as stadiums and large buildings, working behind the scenes to boost wireless coverage through a network of strategically placed antenna nodes. This ensures that every corner is connected, enhancing user experience in challenging architectural layouts. Meanwhile, service nodes are the backbone of network management, orchestrating essential functions, including user authentication and mobility management, enabling smooth delivery of services throughout the 5G ecosystem. These components overcome physical and technological hurdles and lay down the infrastructure critical for delivering the next generation of wireless connectivity.
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“Telefonaktiebolaget LM Ericsson at the Forefront of 5G Enterprise Market with a Strong 16.19% Market Share”
The key players in the 5G Enterprise Market include Huawei Technologies Co., Ltd., Deutsche Telekom AG, Nokia Corporation, Telefonaktiebolaget LM Ericsson, AT&T Inc., and others. These prominent players focus on strategies such as expansions, acquisitions, joint ventures, and developing new products to strengthen their market positions.
“Introducing ThinkMi: Revolutionizing Market Intelligence with AI-Powered Insights for the 5G Enterprise Market”
We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the 5G Enterprise Market. ThinkMi stands out as your premier market intelligence partner, delivering unparalleled insights with the power of artificial intelligence. Whether deciphering market trends or offering actionable intelligence, ThinkMi is engineered to provide precise, relevant answers to your most critical business questions. This revolutionary tool is more than just an information source; it’s a strategic asset that empowers your decision-making with up-to-the-minute data, ensuring you stay ahead in the fiercely competitive 5G Enterprise Market. Embrace the future of market analysis with ThinkMi, where informed decisions lead to remarkable growth.
Ask Question to ThinkMi @ https://app.360iresearch.com/library/intelligence/5g-enterprise
“Dive into the 5G Enterprise Market Landscape: Explore 181 Pages of Insights, 298 Tables, and 22 Figures”
PrefaceResearch MethodologyExecutive SummaryMarket OverviewMarket Insights5G Enterprise Market, by Equipment5G Enterprise Market, by Organization Size5G Enterprise Market, by End UserAmericas 5G Enterprise MarketAsia-Pacific 5G Enterprise MarketEurope, Middle East & Africa 5G Enterprise MarketCompetitive LandscapeCompetitive PortfolioInquire Before Buying @ https://www.360iresearch.com/library/intelligence/5g-enterprise
Related Reports:
5G Non-Terrestrial Network Market – Global Forecast 2024-20305G in Defense Market – Global Forecast 2024-20305G Satellite Communication Market – Global Forecast 2024-2030About 360iResearch
Founded in 2017, 360iResearch is a market research and business consulting company headquartered in India, with clients and focus markets spanning the globe.
We are a dynamic, nimble company that believes in carving ambitious, purposeful goals and achieving them with the backing of our greatest asset — our people.
Quick on our feet, we have our ear to the ground when it comes to market intelligence and volatility. Our market intelligence is diligent, real-time and tailored to your needs, and arms you with all the insight that empowers strategic decision-making.
Our clientele encompasses about 80% of the Fortune Global 500, and leading consulting and research companies and academic institutions that rely on our expertise in compiling data in niche markets. Our meta-insights are intelligent, impactful and infinite, and translate into actionable data that support your quest for enhanced profitability, tapping into niche markets, and exploring new revenue opportunities.
Contact 360iResearchMr. Ketan Rohom360iResearch Private Limited,Office No. 519, Nyati Empress,Opposite Phoenix Market City,Vimannagar, Pune, Maharashtra,India – 411014.Email: [email protected]: +1-530-264-8485India: +91-922-607-7550
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Artificial Intelligence
SimSpace Welcomes Matt Knutsen as New Chief Revenue Officer to Spearhead Expansion Plan
SimSpace strengthens their leadership team, appointing Knutsen to drive revenue growth for the company as it expands further into the public sector
BOSTON, May 2, 2024 /PRNewswire/ — SimSpace, the US-based industry leader in AI-Powered cyber ranges, announced today the appointment of Matt Knutsen as its new Chief Revenue Officer (CRO). Matt will champion SimSpace’s global sales and revenue growth strategy. He will drive expansion initiatives and foster strategic partnerships to stress test businesses’ and state agencies’ people, processes and technologies against the most advanced adversaries.
With more than 20 years of experience in the field, Matt most recently held the position of CRO at cyber training provider Immersive Labs, where he increased revenue growth by over 4000% and attracted over $180M in investment. He also launched the company into new markets, expanding the team across Australia, Europe, the Middle East, New Zealand and the US. The combination of Matt’s wealth of experience and his in-depth industry knowledge make him well-equipped to lead SimSpace’s next phase of growth.
As nation-state attacks rise in frequency, and AI drives a new wave of severe cyberattacks, companies also have to navigate uncertain economic conditions. SimSpace empowers organizations to cut unnecessary spending through stack optimization, allowing CISOs to maximize their ROI and effectiveness of their technology stack. Knutsen’s influence in the field will propel the SimSpace Platform to new heights, advancing access for companies and governments that need to optimize their cybersecurity defenses and safeguard their critical infrastructure from an increasingly volatile threat landscape.
Matt Knutsen is the most recent addition to SimSpace’s Executive Leadership Team, following Clint Sand’s appointment as Chief Product Officer in February 2024. His appointment underscores SimSpace’s continued growth trajectory, headed by the $45M they secured in funding from L2 Point Management, bringing the total capital raised over the past year to $70M. The company has also bolstered their presence in the public sector, marked by their recent partnership with Carahsoft and their multi-year contract with Florida to enhance the state’s cybersecurity preparedness. SimSpace’s high fidelity cyber ranges and simulations will enable state agencies and programs like Cyber Florida to rehearse and respond to cyberattacks.
Commenting on Matt’s arrival, SimSpace CEO William Hutchison said, “Matt is a seasoned executive, who has accumulated years of knowledge on cybersecurity best practices and established himself as a leading authority in cyber range exercises. His industry influence, strategic vision and conviction in the importance of cybersecurity preparedness will shape the future success of the company at this crucial time of expansion. With Matt leading our revenue organization, we have full confidence in our capacity to deepen our valued partnerships and build strong, new connections which will further elevate SimSpace’s position as a trusted cybersecurity partner.”
Matt Knutsen, Chief Revenue Officer commented, “I’m looking forward to bringing a proactive approach to cybersecurity risk management to even more private and public sector organizations. I’ve already been impressed by SimSpace’s high-fidelity cyber range simulations, both on and off premise. It’s a great time to be joining the company and I’m excited to build upon SimSpace’s recent rapid growth with even more partnerships.”
About SimSpace
SimSpace is the global leader in AI-Powered cyber ranges, founded by experts from U.S. Cyber Command and MIT’s Lincoln Laboratory to respond to a new era of unprecedented cyber threats. Having raised nearly $70 million in funding over the past year, the company’s Platform enables the most sophisticated enterprises, governments, and critical national infrastructure organizations to find intelligence-driven answers to the most vexing security, governance, training, and cyber readiness questions. SimSpace provides high-fidelity cybersecurity simulations, training, and safe live-fire exercises to Fortune 2000 financial, retail, insurance, and other commercial markets. SimSpace’s Platform results in an average reduction in cyber operational costs of 30% and a 40% reduction in breaches.
For more information, please visit: www.SimSpace.com.
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