Artificial Intelligence
Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
– New IND Expands Liver Disease Pipeline for CRV431 –
– IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular Carcinoma Treatment –
– New IND Provides for Complementary Therapeutic Approach of Treating NASH and Liver Cancer with a Single Once-a-Day Oral Agent –
EDISON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (“HCC”).
On July 29, 2019, Hepion received FDA authorization of an IND to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed Phase 1 studies in healthy volunteers and, more recently, announced positive data from its Phase 2a ‘AMBITION’ trial in subjects with presumed F2 and F3, where CRV431 was well tolerated, and all primary endpoints were met. A larger Phase 2b NASH study of over 300 subjects with paired liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated in 2022. ASCEND-NASH will evaluate CRV431’s effects on the histologic endpoints of liver steatosis and fibrosis over 12 months dosing.
“Liver cancer is the sixth most prevalent cancer worldwide and is the second most common cause of cancer death,”1 commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “The most common form of liver cancer is HCC, which comprises about 90% of all liver cancers. Major risk factors associated with development of HCC include NASH, liver fibrosis and cirrhosis, viral hepatitis, chronic alcohol consumption, and metabolic syndrome. As the global prevalence of NASH is increasing, the incidence of HCC arising from NASH is also increasing. Approximately 25% to 30% of NASH-related HCC develops in the absence of cirrhosis and, therefore, occurs without many of the symptomatic warning signs of this aggressive form of cancer. An orally administered drug that simultaneously targets NASH and HCC would offer an advantageous therapeutic strategy to patients suffering these potentially life-threatening conditions. CRV431’s novel potential stems from its pleiotropic pharmacologic activities and from its ability to target the liver, allowing for a drug candidate ideally suited for the treatment of liver disease.”
Dr. Hobbs continued, “Another potentially important benefit is the patient experience while taking CRV431. Most cancer drugs are delivered by injection and are associated with significant side effects. In contrast, CRV431 is orally administered and has been shown to be well tolerated in clinical trials to date. We are optimistic that CRV431 may provide significant anti-cancer effects without imposing additional challenges and distress often associated with cancer drugs.”
Robert Foster, PharmD, PhD, Hepion’s CEO, said, “Increased cyclophilin isoform expression has been associated with negative outcomes in HCC. Importantly, CRV431 potently inhibits many of these isoforms in humans. Cyclophilins are enzymes that regulate many molecular and cellular activities that become dysregulated both in NASH and HCC. These dysregulated activities can lead to aberrations in signal transduction pathways, cell proliferation, cell death, extracellular environment including increased fibrosis, energy metabolism, inflammation, and immunity. Therapeutic intervention with CRV431 administration may reduce the pathologic potential associated with heightened cyclophilin activities in NASH and HCC, potentially allowing for a return to a healthier state.”
Dr. Foster continued, “CRV431 has shown anti-tumor activity in multiple animal studies, and our research team has been intensively investigating the specific mechanisms that have produced these outcomes. Our investigations have revealed interesting direct and indirect effects of CRV431 on cancer cells and tumors. For example, gene expression analyses have demonstrated CRV431’s ability to attenuate drug-resistance pathways and Wnt-β-catenin-Myc signaling, the latter being mutationally over-activated in 30% to 50% of human HCC tumors. We recently also found that CRV431 increased lymphocyte infiltration into liver tumors in a manner similar to an immune checkpoint inhibitor, also known as an anti-PD-1 antibody, which is considered to be an important anti-tumor approach. We believe that the wide array of pharmacologic activities offered by CRV431 in the treatment of NASH and HCC should bode well for the further clinical development in both important indications.”
Reference
1Hepatocellular Carcinoma. Nature Reviews Disease Primers 7, 7 (2021).
About Hepion Pharmaceuticals
The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]
Artificial Intelligence
Overseas Expansion Strategy of K-OTT Introduced in France, KOCCA holds the ‘2024 Korea-France Content Forum’
– The ‘Korea-France Content Forum’ held to establish the Foundation for K-OTT’s oversea expansion
PARIS, May 24, 2024 /PRNewswire/ — The Ministry of Culture, Sports and Tourism (Minister Yu In-chon) and the Korea Creative Content Agency (President, Jo Hyun-rae, hereafter KOCCA) held the ‘2024 Korea-France Content Forum’ on May 24th during the Korea Expo in Paris, France.
The ‘2024 Korea-France Content Forum’ featured a keynote session (K-OTT’s Strategies in Global market) presenting K-OTT’s strategies for international expansion and a roundtable session (Strategies in the Era of Streaming) discussing the growth of OTT platforms and collaborative approaches with production companies.
The forum featured participation from various industry leaders including Kun hee Park (CEO, Wavve Americas), Sangjin Lee (Head of content IP Business, LG U+), Seung ae Sohn (Executive Director, Showbox), Ji ae Sohn (Ambassador for Cultural Cooperation), Moonju Kim (General Director, France Business Center, KOCCA), Isabelle Degeorges (President, Gaumont Television France) which produced the French Netflix original series, participated.
Strategy announcement by Wavve Americas (KOCAWA), the first K-OTT’s launched in Europe
During the Keynote Session, Park Kun Hee – CEO of Wavve Americas, the first domestic OTT Platform to launch services in Europe, Took the stage to discuss the international expansion strategy of KOCOWA, which started offering services in 39 countries including Europe since April of this year. Following this, Lee Sangjin, Head of Content IP Business of LG U+, presented the expansion strategy of LG U+ Mobile TV, encompassing diverse original content.
During the round-table session, participants shared thoughts and solutions regarding the survival strategies of local OTT platforms and production companies amidst the rapid waves of change brought about by the emergence of global OTT platforms.
In particular, through this forum, we were able to observe the proactive implementation of IP protection policies by local production companies in France, aimed at sustainable content creation. Isabelle Degeorges, CEO of Gaumont Television France, noted, “With the introduction of the European Audiovisual Media Services Directive (AVMSD), platforms and production companies can share IPs three years after supplying the content.” Kim Moon-joo, Director of the Korea Creative Content Agency’s France Business Center, participated as a panelist, introducing policies aimed at enhancing the competitiveness of K-OTT and fostering collaboration with production companies.
Park Kun Hee, CEO of Wavve Americas, who participated in the event, stated, “It was a meaningful opportunity to introduce our platform locally in Europe in line with KOCOWA’s expansion into the region”. Additionally, Kyoungbon Koo, Director Broadcasting & Video Content Division at KOCCA commented, “It was a meaningful occasion to not only introduce K-OTT’s strategies to Europe but also to exchange ideas on collaboration between Korea and France. We will continue to focus on activating various forms of collaboration with major international partners in the future”.
KOCCA supports the overseas expansion of excellent domestic OTT content and platforms through the newly established Local OTT Specialized Support Program this year. This initiative aims to enhance the competitiveness of domestic OTT platforms and content by adapting to the changing industrial environment.
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Artificial Intelligence
IoT Node and Gateway Market worth $604.7 billion by 2029 – Exclusive Report by MarketsandMarkets™
CHICAGO, May 24, 2024 /PRNewswire/ — The IoT Node and Gateway market is projected to grow from USD 424.6 billion in 2024 and is estimated to reach USD 604.7 billion by 2029; it is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.3% from 2024 to 2029 according to a new report by MarketsandMarkets™. The growth of the IoT Node and Gateway market is driven by the Provision of increased IP address space through IPv6, Emergence of 5G technology, and Increasing need for data centers.
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Browse in-depth TOC on “IoT Node and Gateway Market”
410 – Tables70 – Figures390 – Pages
IoT Node and Gateway Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 424.6 billion
Estimated Value by 2029
$ 604.7 billion
Growth Rate
Poised to grow at a CAGR of 7.3%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By Hardware, End-use Application and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Requirement for wireless spectrum and licensed spectrum
Key Market Opportunities
Accelerated IoT adoption in healthcare sector
Key Market Drivers
Rising use of wireless smart sensors and networks
By Hardware, the Logic Devices are projected to grow at a high CAGR of IoT Node and Gateway market during the forecast period.
Logic devices can adapt to changing requirements even after deployment. As new features or functionalities are needed, the logic within the device can be reprogrammed to accommodate these changes, extending the useful life of the product and reducing the need for hardware revisions. The integration of FPGA technology into IoT devices further enhances these advantages. The integration of FPGAs into IoT nodes and gateways empowers manufacturers to develop highly optimized, customizable, and scalable solutions that meet the diverse needs of IoT applications. Tesla’s Full Self-Driving (FSD) computer utilizes FPGAs to handle complex neural network computations for autonomous driving algorithms. This allows them to potentially improve their FSD capabilities through software updates that reconfigure the logic within the FPGAs.
BFSI segment in IoT Node and Gateway Market is projected to grow at a highest CAGR during the forecast period.
BFSI sector can use IoT technology to provide more convenient solutions for customers. IoT can be used to perform data collection in real time and for instant communication between devices. For instance, it can facilitate cashless payments using an RFID scanner to identify products in the shopping cart and mobile wallet. The adoption of mobile point of sale (mPOS) systems and kiosks is fundamentally reshaping the landscape of the BFSI market. mPOS facilitates transactions anytime, anywhere, benefiting unbanked populations and enabling temporary service points for events. Kiosks offer convenient banking functionalities, reducing wait times and freeing up staff for complex inquiries. These technologies drive cost savings by requiring less investment and automating routine tasks, allowing resources to be reallocated strategically. They provide rich data for personalized services, fraud detection, and operational optimization. mPOS systems and kiosks promote financial inclusion by extending services to remote areas, fostering economic activity and well-being.
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North America accounts for the largest share in IoT Node and Gateway Industry.
The North American IoT market is poised to grow, driven by government efforts to transition cities into smart urban centers. The growing need for sophisticated IoT solutions, fueled by the widespread availability of high-speed data, will further propel market expansion in this region. Furthermore, North America’s dynamic IoT node and gateway ecosystem features established players like Intel Corporation (US), Texas Instruments Incorporated (US), Dell (US), and Cisco Systems (US), driving competition, innovation, and affordability. Increasing research and development at industry levels is broadening the application areas of IoT in various industries, such as retail, consumer electronics, automotive and transportation, and healthcare, especially in the US. The increased demand for effective solutions and focus on early, accurate, and fast diagnosis of diseases has led to huge investments in technological developments in the healthcare sector.
Key Players
Key companies operating in the IoT Node and Gateway companies are Intel Corporation (US), Qualcomm Technologies, Inc. (US), Texas Instruments Incorporated (US), STMicroelectronics (Switzerland), Microchip Technology Inc. (US), Huawei Technologies Co., Ltd. (China), NXP Semiconductors N.V. (Netherlands), Cisco Systems, Inc. (US), Hewlett Packard Enterprise Development LP (US), TE Connectivity Ltd (Switzerland), Advantech Co., Ltd. (Taiwan), Dell Technologies (US), among others.
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Related Reports:
IoT Technology Market by Node Component (Sensor, Memory Device, Connectivity IC, Processor, Logic Devices), Software Solution (Remote Monitoring, Data Management), Platform, Service, End-use Application, Geography – Global Forecast to 2029
Industrial IoT Market Size, Share & Industry Growth Analysis Report by Device & Technology, Connectivity Type, Software, Vertical (Manufacturing, Energy, Oil & Gas, Healthcare, Retail, Transportation, Metals & Mining, Agriculture), and Geography – Global Growth Driver and Industry Forecast to 2026
Internet of Robotic Things Market (IoRT) by Component (Sensor, Power, Control), Service (Professional, Managed), Platform (Device, Application, Network), Software (Analytics, Data, Security, Monitoring, Bandwidth), Application – Global Forecast to 2022
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Artificial Intelligence
atNorth Wins ‘Colocation Provider of the Year’ and ‘Digital Infrastructure Project of the Year’ at Industry Award Events
AtNorth recognized at the Electrical Review & Data Centre Review Awards and the Tech Capital Awards.
REYKJAVÍK, Iceland, May 24, 2024 /PRNewswire/ — atNorth, the leading Nordic colocation, high-performance computing, and artificial intelligence service provider has today announced further acknowledgement in the industry as it wins two significant awards.
The business has been awarded the `Colocation Provider of the Year’ award at the Electrical Review & Data Centre Review Awards. atNorth has undertaken a significant expansion strategy in recent years, that has ensured that the business can offer high performance infrastructure at speed and scale. This award reflects the business’ growth journey as it continues to innovate and adapt to technological advancements and client requirements.
atNorth has also won the `Digital Infrastructure Project of the Year’ at the Tech Capital Awards for its work with client, Shearwater Geoservices. The global marine imaging and processing leader achieved a 92% reduction in CO2 output and an 85% reduction in cost by moving a portion of its UK HPC infrastructure to one of atNorth’s Icelandic data center sites.
Fueled by the abundant renewable power sources of the Nordics, atNorth`s services deliver performance and efficiency for high density workloads in a sustainable way that enables clients to decarbonize their IT footprint and reduce overall costs.
Winners are voted for by a panel of industry experts for both awarding bodies in a process that aims to recognize the outstanding achievements within the digital infrastructure industry.
“We are thrilled to receive these acknowledgments for our data center services”, says Eyjólfur Magnús Kristinsson, CEO at atNorth. “atNorth has experienced significant growth over the last couple of years and this industry recognition is a testament to our dedication to delivering excellence across the board. We are determined to continue decarbonizing the world’s most demanding workloads in an efficient, sustainable, and cost-effective way.”
The news follows atNorth’s announcements of colocation clients Crusoe, BNP Paribas and Advania. The business has also received recent recognition from multiple other awarding bodies including; the Datacloud Global Awards, the Energy Awards, TechRound’s Sustainability60 and the UK Green Business Awards.
About atNorth
atNorth is a leading Nordic data center services company that offers sustainable, cost-effective, scalable colocation and high-performance computing services trusted by industry-leading organizations. The business acquired leading High-Performance Computing (HPC) provider, Gompute, in 2023 enabling a compelling full stack offering tailored to AI and other critical high-performance workloads.
With sustainability at its core, atNorth’s data centers run on renewable energy resources and support circular economy principles. All atNorth sites leverage innovative design, power efficiency, and intelligent operations to provide long-term infrastructure and flexible colocation deployments. The tailor-made solutions enable businesses to calculate, simulate, train and visualize data workloads in an efficient, cost-optimized way.
atNorth is headquartered in Reykjavik, Iceland and operates seven data centers in strategic locations across the Nordics, with additional sites to open in Helsinki, Finland and in Denmark in Q4 2024, as well as its tenth site ready for operation in Kouvola, Finland in 2025.
For more information, visit atNorth.com or follow atNorth on LinkedIn or Facebook.
Press Contact:Caroline BruntonKite Hill PR for atNorth+44 (0) 7796 274 [email protected]
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