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
Complyport’s new AI tool – ViCA.Chat – set to revolutionise compliance support services
LONDON, June 14, 2024 /PRNewswire/ — ViCA.Chat, the Virtual Compliance Assistant powered by AI technology, is set to transform regulatory compliance consulting. Developed by ComplyMAP Group’s AI engineers and Complyport’s compliance consulting teams, ViCA redefines compliance support services and propels governance, risk and compliance consulting into a new era of innovation.
Offering real-time assistance across a vast array of UK and EU regulatory frameworks, ViCA delivers unparalleled efficiency, detail and precision in disentangling and dealing with complicated regulatory frameworks.
The key differentiator of ViCA is its specialised and purposely constructed unique databases that leverage Complyport’s 22 years of regulatory expertise, combined with tailored AI training tools, enabling ViCA to operate as an experienced compliance consultant. A dedicated human support team continuously improves and updates ViCA’s knowledge and responses through a feedback loop process and quality assurance sessions. This powerful symbiosis of AI and human expertise sets ViCA apart and ensures businesses have the latest regulatory information instantaneously and seamlessly.
As a result, ViCA’s specialised regulatory database goes beyond readily available online resources which feature into traditional AI tools. ViCA offers exclusive insights, proprietary regulatory interpretations, historical data, bespoke and purposely structured compliance documentation and templates. With advanced scraping capabilities, ViCA also extracts relevant data from selected websites and publicly available information, ensuring an up-to-date and comprehensive understanding of compliance requirements across industries.
From agile fintech startups to established law firms, financial institutions, regulatory bodies, insurance providers, as well as compliance consultants, ViCA seamlessly adapts to unique compliance needs. Its user-friendly interface ensures navigating and analysing regulatory data is swift and intuitive, streamlining the compliance workflow.
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Artificial Intelligence
LoRa and LoRaWAN IoT Market worth $32.7 billion by 2029- Exclusive Report by MarketsandMarkets™
CHICAGO, June 14, 2024 /PRNewswire/ — The LoRa and LoRaWAN IoT Market is expected to reach USD 32.7 billion by 2029 from USD 8.0 billion in 2024, at a Compound Annual Growth Rate (CAGR) of 32.4 % during 2024–2029, according to a new report by MarketsandMarkets™.
Browse in-depth TOC on “LoRa and LoRaWAN IoT Market”
320 – Tables 58 – Figures294 – Pages
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Scope of the Report
Report Metrics
Details
Market size available for years
2018-2029
Base year considered
2023
Forecast period
2024–2029
Forecast units
Value (USD Billion)
Segments Covered
Offering, Network Deployment, Application, End User, and Region
Region covered
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
List of Companies in LoRa and LoRaWAN IoT
The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US).
The LoRaWAN ecosystem influences development of tools, software libraries, and cloud-based platforms that streamline the creation, deployment, and management of IoT solutions. Continuously evolving, this ecosystem boasts a burgeoning array of vendors providing LoRa-compliant devices, gateways, and network management solutions. This vibrant competition within the ecosystem propels innovation while driving down costs for end-users. Moreover, the development of interoperable solutions fosters seamless integration and deployment of LoRaWAN networks, simplifying the implementation process for businesses and organizations. As the ecosystem continues to expand and mature, it empowers developers, system integrators, and IoT enthusiasts to unleash their creativity, accelerate time-to-market, and unlock the full potential of LoRaWAN technology in diverse applications and industries.
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Based on network deployment, the public network segment to hold the largest market size during the forecast period.
The robust security features integrated into public LoRaWAN networks play a significant role in driving the growth and adoption of LoRaWAN technology in the market. End-to-end encryption ensures that data transmitted between devices and gateways is protected from unauthorized access or interception, safeguarding sensitive information such as sensor readings, location data, and command messages. Message integrity checks verify the integrity of data packets, detecting any tampering or alteration during transmission and ensuring data authenticity and reliability. Additionally, mutual authentication mechanisms establish trust between devices and gateways, verifying the identity of both parties before allowing communication to occur. These security measures provide organizations and end-users with confidence in the integrity and confidentiality of their data, mitigating concerns related to data privacy, cybersecurity threats, and regulatory compliance. As a result, implementing robust security features in public LoRaWAN networks enhances trust and credibility in the technology, driving increased adoption and market growth as organizations seek reliable and secure connectivity solutions for their IoT deployments.
By offering, the services segment is expected to hold a higher growth rate during the forecast period.
IoT service providers are pivotal in driving adoption by developing vertical-specific solutions finely tuned to the distinct needs of industries like agriculture, healthcare, logistics, and smart cities. In agriculture, for instance, IoT services offer solutions for precision farming, crop monitoring, and livestock management, enabling farmers to optimize irrigation, monitor soil health, and enhance yields. Similarly, IoT services facilitate remote patient monitoring, asset tracking, and inventory management in healthcare, improving patient care, reducing costs, and ensuring compliance with regulatory standards such as HIPAA. In logistics, IoT services provide real-time tracking of shipments, fleet management, and predictive maintenance, enhancing supply chain visibility, efficiency, and reliability. For smart cities, IoT services offer solutions for traffic management, waste management, energy optimization, and public safety, transforming urban infrastructure and enhancing the quality of life for residents. By addressing industry-specific challenges, compliance requirements, and use cases, vertical-specific IoT solutions deliver tangible business value, driving adoption and fueling the growth of the IoT services market across diverse sectors.
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Asia Pacific is expected to hold a higher growth rate during the forecast period.
In the Asia Pacific region, where agriculture serves as a cornerstone of many economies, adopting IoT technologies, particularly LoRa and LoRaWAN, is revolutionizing traditional farming practices. LoRaWAN’s long-range connectivity and low-power consumption make it well-suited for deployment in rural agricultural settings, where access to reliable connectivity may be limited. Through LoRa-based IoT solutions, farmers can implement precision agriculture techniques to address pressing challenges such as water scarcity, soil degradation, and unpredictable weather patterns. LoRa-enabled sensors facilitate real-time monitoring of soil moisture levels, temperature, and humidity, allowing farmers to optimize irrigation schedules and conserve water resources. Remote sensing technologies powered by LoRaWAN enable farmers to gather actionable insights on crop health, pest infestations, and nutrient deficiencies, facilitating timely interventions and improving overall crop management practices. Furthermore, LoRa-based crop analytics platforms provide farmers with data-driven decision support tools, helping them optimize planting strategies, improve yield forecasting, and mitigate the impact of climate change on agricultural productivity. By harnessing the power of LoRa and LoRaWAN IoT solutions, farmers in the Asia Pacific region can increase yields, conserve resources, and enhance resilience to environmental challenges, driving the adoption and growth of the LoRaWAN IoT market in the agricultural sector.
Top Key Companies in LoRa and LoRaWAN IoT Market:
The major vendors covered in the LoRa and LoRaWAN IoT Market are The Bosch Group (Germany), Cisco (US), Orange SA (France), Comcast Corporation (US), Semtech (US), NEC Corporation(Japan), Tata Communications (India), AWS (US), Advantech (Taiwan), SK Telecom (South Korea), Murata (Japan), Kerlink (France), Actility (France), Digi International (US), MultiTech (US), Ezurio (US), Sensoterra (Netherlands), Nwave Technologies (US), RAKwireless (China), TheThings.io (Spain), Datacake (Germany), Milesight (China), LORIOT (Switzerland), Exosite (US), Orbiwise (Switzerland), Netmore Group (Sweden), and Radio Bridge Inc (US). These players have adopted various growth strategies, such as partnerships, agreements and collaborations, new product launches, enhancements, and acquisitions to expand their footprint in the LoRa and LoRaWAN IoT Market.
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Artificial Intelligence
Scoring a Seat at UEFA EURO 2024™ with Top-Performing AI-Powered TOSHIBA TV Lineup
HONG KONG, June 14, 2024 /PRNewswire/ — Football fans are in for a treat as they gear up for UEFA EURO 2024™ with Toshiba TV’s top-performing Gaming TV Z670. As the OFFICIAL TV OF UEFA EURO 2024™, Toshiba TVs present immersive viewing of the football game by their AI-powered TV lineup. To celebrate the brilliant moments it can bring, Toshiba TV are gifting USD100 Amazon Gift Card via their social platform! By simply like, follow and comment on @ToshibaTVGlobal, fans can boost their chances of scoring this prize.
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