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OncXerna Therapeutics Announces Upcoming ASCO Poster Featuring Data Showing the Phase 2 Glioblastoma Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide Met its Primary Endpoint

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Trial’s 73% twelve-month overall survival rate in newly diagnosed glioblastoma patients compares favorably to historical benchmark of 60%

Results show median progression-free survival of 6.9 months and median overall survival of 15.4 months

Treatment led to depletion of immunosuppressive myeloid-derived suppressor cells within the tumor microenvironment, suggesting bavituximab may synergistically combine with checkpoint inhibitors

WALTHAM, Mass., June 03, 2022 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced new clinical data from an investigator-sponsored Phase 2 trial evaluating bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients. The data, which show that the trial met its primary endpoint, will be featured in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place both virtually and in-person at the McCormick Place Convention Center in Chicago, Illinois.

Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor designed to reverse immune suppression. The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP)-funded Phase 2 investigator-sponsored trial that will be featured in the ASCO poster was an open-label, single-arm study in newly diagnosed IDH wild-type GBM patients that was designed to evaluate the safety and efficacy of bavituximab combined with chemoradiation and adjuvant temozolomide. Per the trial protocol, success on the primary endpoint was defined as a twelve-month overall survival rate (OS-12) of greater than or equal to 72% in evaluable patients.

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“Novel approaches are needed to treat GBM, as the current standard-of-care of chemoradiation and temozolomide has historically provided an OS-12 of only 60%,” said Elizabeth Gerstner, M.D., Mass General Cancer Center, the study’s lead investigator. “The Phase 2 results being presented at ASCO suggest bavituximab modulates the immunosuppressive GBM microenvironment, demonstrating its on-target effects. The OS-12 of evaluable patients exceeded both the study’s pre-specified criteria and the historical benchmark. Improved survival also correlated with positive changes in tumor immune cell gene expression and reductions in cerebral blood flow, which indicates that bavituximab was a contributor to treatment response and supports continued clinical evaluation in GBM.”

Key data and conclusions from the ASCO poster include:

Efficacy data in evaluable patients (N = 33, median age of 59)

  • OS-12: 73% (95% confidence interval: 59% – 90%)
  • Median progression-free survival (PFS): 6.9 months (95% confidence interval: 6.2 – 9.7 months)
  • Median overall survival (OS): 15.4 months (95% confidence interval: 13.3 – 23.6 months)
  • Disease control rate: 91% (30/33)
  • Overall response rate: 12% (4/33)

Safety findings:

  • The studied combination was generally well tolerated. There were eight grade 3 or 4 adverse events (AEs) and no grade 5 AEs observed.

Immune profile and MRI assessments:

  • A statistically significant reduction of pro-tumor, immunosuppressive, myeloid-derived suppressor cells (MDSCs) was observed post-treatment
  • Tumor samples from patients with longer PFS and OS showed a significantly positive shift in myeloid-related gene expression
  • The studied combination was shown to have anti-angiogenic effects as evidenced by a post-treatment decrease in relative cerebral blood flow

Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, commented, “Confirming the on-target effect of bavituximab in modulating the GBM immune microenvironment is a significant finding that suggests combining bavituximab with an immune checkpoint inhibitor is a reasonable potential next step in its development. Incorporating our Xerna™ TME panel prospectively in a future study may further enable us to understand which patients would most likely benefit from this treatment approach as well as bavituximab’s potential to significantly improve outcomes in a setting where new treatment options are desperately needed. We look forward to discussing these latest Phase 2 data with key thought leaders as we assess next steps for bavituximab in GBM.”

The Xerna TME Panel is OncXerna’s novel RNA gene expression-based diagnostic panel. It uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). By utilizing the Xerna TME Panel, OncXerna aims to match a specific patient’s tumor with the drugs best suited to treat that tumor.

The ASCO poster (# 368), entitled, Phase 2 Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide in Newly Diagnosed Glioblastoma, will be presented during the ASCO Annual Meeting’s “Central Nervous System Tumors” poster session, which is taking place on June 5, 2022, beginning at 8:00 a.m. CT (9:00 a.m. ET). Following its presentation at the conference, a copy of the poster will be available on the OncXerna website here.

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About the Phase 2 Trial

This study is one of three investigator-sponsored studies funded through a collaboration between the NCCN ORP and OncXerna Therapeutics. The investigator-sponsored study was led by Elizabeth Gerstner, M.D., Mass General Cancer Center. The Phase 2 trial was an open-label, single-arm study designed to evaluate the safety and efficacy of bavituximab with chemoradiation and adjuvant temozolomide in adult patients with newly diagnosed glioblastoma. The trial included 33 evaluable patients who were treated with bavituximab weekly, temozolomide daily, and chemoradiotherapy in accordance with hospital guidance. The primary endpoint of the trial was OS-12, with the trial’s pre-specified statistical analysis plan indicating an OS-12 greater than or equal to 72% would result in the null hypothesis being rejected. Secondary endpoints included progression-free survival, overall survival, radiographic response, and toxicity assessments. Exploratory assessments evaluated the immune profile in tumor tissue and peripheral blood mononuclear cells with treatment and the impact of treatment on relative cerebral flood flow. For more information, see ClinicalTrials.gov Identifier: NCT03139916.

About Bavituximab

Bavituximab is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs).  This biology is relevant across multiple types of solid tumors. A Phase 2 clinical trial is evaluating the combination of bavituximab with KEYTRUDA to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.  

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About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

About OncXerna Therapeutics

OncXerna Therapeutics is a clinical stage oncology company developing novel monoclonal antibodies to treat solid tumors. In combination with its innovative precision medicine platform, the Xerna TME Panel, OncXerna leverages artificial intelligence technologies and RNA expression-based biomarkers to match a specific patient’s tumor with the drugs best suited to treat that tumor. By integrating our novel Xerna TME Platform with our deep expertise in clinical development, we believe we can accelerate the development, approval and commercialization of drug product candidates and bring meaningful new treatments to patients as soon as possible.  Our current clinical pipeline includes the company’s lead product candidate, navicixizumab, which is a bispecific antibody that targets both VEGF and DLL4 to treat solid tumors and is currently entering a Phase 3 study for the treatment of advanced ovarian cancer. Another product candidate, bavituximab, is an investigational antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials to treat a specific subset of patients with advanced gastric cancer to improve their response to anti-PD-1 treatment. Navicixizumab and bavituximab are investigational agents that have not been approved and have not been demonstrated to be safe or effective for any use.  For more information, please visit oncxerna.com, or follow us on LinkedIn and Twitter.

About the National Comprehensive Cancer Network (NCCN)

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The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. Visit NCCN.org for more information on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and other initiatives. Follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg and Twitter @NCCN.

Investor and Media Contact:

Ashley R. Robinson
LifeSci Partners, LLC
[email protected]

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Artificial Intelligence

How AIoT shapes the future of mobility: Hikvision at ITS World Congress 2024

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HANGZHOU, China, Sept. 27, 2024 /PRNewswire/ — Hikvision made a significant impact at the ITS World Congress in Dubai with its captivating theme, “Embrace AIoT for safer, smarter, and greener mobility.” Its booth became a hub of innovation, where visitors explored AIoT solutions that are reshaping the transportation landscape, sparking deep conversations on the future of urban mobility.

Road safety revolution: harnessing AIoT for secure transportation
Hikvision’s commitment to road safety was on full display at its booth through the impressive array of AIoT solutions designed to create secure and reliable traffic environments. The company’s technology provides 24/7 traffic monitoring, ensuring continuous oversight of motor vehicles, non-motorized vehicles, pedestrians and environmental factors. This comprehensive, real-time information collection enables traffic managers to prevent accidents and enhance road safety. Among the showcased products was the 20 MP IR ANPR Checkpoint Capture Unit, renowned for its high-definition capture capabilities, bolstering traffic safety measures.
A standout innovation was the integration of advanced radar and camera technologies, ensuring uninterrupted, comprehensive detection even in adverse weather conditions. The Radar-Video Fusion Incident Detection Cameras, featured prominently in the product experience area, enable early detection and warning of potential hazards. They are particularly effective in challenging situations such as curved roads, blind spots at intersections, and obstacles beyond visual range.
Attendees also engaged with onboard monitoring products on the simulated bus, including dome network cameras, which is designed to enhance passenger safety. Driving assistance products, such as the Driver Status Monitor (DSM), were demonstrated to mitigate unsafe driving behaviors and ensure safer journeys.
Urban mobility redefined: smart traffic innovations
In the realm of smarter mobility, Hikvision showcased its multidimensional sensing technology, which integrates visible light sensors, infrared sensors, radar, and sonar. This technology expands perception capabilities, significantly improving traffic management and situational awareness. The use of AI-powered comprehensive sensing elevates incident monitoring and violation detection to unprecedented levels of accuracy and efficiency.
A major attraction was the Radar-Video Fusion TandemVu PTZ Camera, which integrates millimeter-wave radar with high-resolution cameras for extensive traffic detection and data analysis. AI-based algorithms combine these two systems to enhance target information, detecting up to 16 types of incidents. This leads to the development of a large-scale fusion model that merges spatial physical data with image semantic information. The result is ultra-long-range perception, achieving over 95% accuracy in vehicle trajectory detection. This robust system improves traffic violation management and optimizes traffic flow, significantly enhancing road efficiency.
At the simulated bus station, visitors observed how AI-assisted people counting automated the collection of passenger flow statistics at peak stop hours and bus line frequency during busy periods. Paired with smart bus stop digital signage, the solution improves bus service quality, operational efficiency, passenger experience, and overall public transport effectiveness.
Sustainable transportation: leading the charge for greener cities
Hikvision’s commitment to sustainable urban mobility was evident through its innovative green wave technology and eco-friendly checkpoint solutions. Green wave technology efficiently manages traffic flow to reduce congestion and lower carbon emissions, aligning with global sustainability goals. Visitors were particularly impressed by a case study showcasing a green wave solution implemented in Zhoushan, China. Over a stretch of 21 kilometers and 34 intersections, this main road cut travel times by 50%.
The use of DarkFighterX technology in checkpoint cameras also received significant attention. This technology senses both visible and invisible light, resulting in more accurate and realistic images. It enhances traffic violation enforcement efficiency while minimizing the need for high ambient light levels, thus reducing light pollution. The 9M DarkfightX ANPR Checkpoint Camera exemplified this dedication to environmental stewardship.
Frank Zhang, President of Hikvision MEA, remarked, “Hikvision supports sustainable urban planning by empowering traffic departments to address congestion and transportation challenges.” He further emphasized, “Our system’s openness fosters a secure and reliable platform for developing smart and green cities. Additionally, our solar technology is extensively utilized in remote areas, while our smart street lighting solutions reduce energy consumption by 20-30%, promoting intelligent urban transportation and advancing global sustainability objectives.”
Hikvision’s presence at the ITS World Congress in Dubai underscored its leadership in integrating AIoT technologies to drive safer, smarter, and greener mobility solutions. The engaging presentations and advanced product demonstrations captured significant attention from industry partners and customers, reaffirming the company’s role as a pioneer in shaping the future of urban transportation. As the world moves towards more intelligent and sustainable transportation systems, Hikvision remains at the forefront, embracing AIoT to create a safer, smarter, and greener future for all.
To find out more about Hikvision’s advanced traffic and public transport solutions, please explore the Hikvision official website.
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Anti-Drone Market worth $7.05 billion by 2029 – Exclusive Report by MarketsandMarkets™

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DELRAY BEACH, Fla., Sept. 27, 2024 /PRNewswire/ — The global anti-drone market was valued at USD 2.16 billion in 2024 and is projected to reach USD 7.05 billion by 2029; it is expected to register a CAGR of 26.7% during the forecast period according to a new report by MarketsandMarkets™. Increasing government spending on counter-drone technologies, rising incidence of critical infrastructure security breaches by unauthorized drones, and surge in adoption of aerial remote sensing technologies to safeguard critical infrastructure are attributed to the demand for anti-drone.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=177013645
Browse in-depth TOC on “Anti-Drone Market” 178 – Tables61 – Figures253 – Pages
Anti-Drone Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 2.16 billion
Estimated Value by 2029
$ 7.05 billion
Growth Rate
Poised to grow at a CAGR of 26.7%
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 System Type, Application, Platform type, Vertical, and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Vulnerability to hacking
Key Market Opportunities
Emphasis on improving unmanned aircraft systems technology
Key Market Drivers
Growing number of illicit activities
By System Type: Hybrid systems to account for the larger market share in the forecasted year.
The hybrid segment accounted for the largest share of the anti-drone market in 2029. The trends of integrating multiple anti-drone technologies are rising since they are most effective in detecting, tracking, and neutralizing drone threats. These systems merge electronic, kinetic, and lasers, providing a comprehensive defense solution against UAVs. Hybrid systems use electronic, kinetic, and laser-based countermeasures to offer optimum protection against drones. These systems are designed to detect, track, identify, categorize, and mitigate drones at operational wide ranges ranging from a few km up to tens of km.
By Platform: The ground-based segment accounted for the largest market share in the forecast year.
The ground-based segment will hold a major share of the anti-drone market in 2029. Many ground-based anti-drone systems use several electronic technologies, such as radar, IR sensors, acoustic systems, and RF & GNSS jammers. MESA radar solutions are used mostly for counter-UAS purposes, protecting critical infrastructure, military camps, and other security-sensitive sites from unauthorized drones. One such solution is EchoGuard, a ground-based airspace management solution that contains a software-defined 3D radar that can be specific to the site. This system can identify single or multiple off-chance drones, including swarms in unauthorized areas. They provide accurate and sustained airspace surveillance for the field of view (FOV) they are configured, and both human and AI-monitored visual checks. The system can be easily transported and integrated directly with the command-and-control centers or another identification sensor for portable use, and multiple units of the system can be combined to cover vast areas or lengths of borders. Major providers of ground-based counter-drone systems include companies like EchoDyne Corporation, DeTect, Meteksan Defense, and WhiteFox Defense. Acoustics-based Discovair G2 utilizes patented microphone arrays. With 128 interconnected microphone elements, the Discovair sensor units can establish azimuth and elevation to the target in real-time using advanced digital signal processing.
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By Region: Americas are expected to hold the largest share of the anti-drone market during the forecast period.
Americas is expected to capture the largest share in the anti-drone industry during the forecast period. The growth can be attributed to protecting crucial infrastructure in the region. Governments, particularly in the US, invest in anti-drone systems for military bases, borders, and critical infrastructure. For Instance, in April 2023, RTX secured a USD 237 million contract from the US Army to provide Ku-band Radio Frequency Sensors (KuRFS) and Coyote effectors. These systems are designed to detect and neutralize unmanned aircraft systems (UAS). The contract includes stationary and mobile systems and a specified quantity of effectors, all aimed at enhancing the Army’s operations within the US Central Command region.
Key Players-
The key companies offering anti-drone companies include RTX (US), Lockheed Martin Corporation (US), Leonardo S.p.A. (Italy), Thales (France), and IAI (Israel).
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Browse Adjacent Market: Semiconductor and Electronics Market Research Reports &Consulting
Related Reports: 
Drone Sensor Market Size, Share, Industry Growth & Trends by Sensor Type, Platform (VTOL Type, Fixed Wing Type, Hybrid Type), Application (Navigation, Collision Detection & Avoidance, Data Acquisition, Motion Detection, Power Monitoring), End Users and Region – Global Forecast to 2029
Smart Agriculture Market Size, Share, Statistics and Industry Growth Analysis Report by Offering (Hardware, Software, Services), Agriculture Type, Farm Size (Large, Medium, Small), Application (Precision Farming, Livestock Monitoring) and Region (America, Europe, Asia Pacific, Row) – Global Forecast to 2028
About MarketsandMarkets™
MarketsandMarkets™ has been recognized as one of America’s best management consulting firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.
Earlier this year, we made a formal transformation into one of America’s best management consulting firms as per a survey conducted by Forbes.
The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the ‘GIVE Growth’ principle, we work with several Forbes Global 2000 B2B companies – helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.
Contact: Mr. Rohan SalgarkarMarketsandMarkets™ INC. 1615 South Congress Ave.Suite 103, Delray Beach, FL 33445USA: +1-888-600-6441Email: [email protected] Our Web Site: https://www.marketsandmarkets.com/Research Insight: https://www.marketsandmarkets.com/ResearchInsight/anti-drone-market.aspContent Source: https://www.marketsandmarkets.com/PressReleases/anti-drone.asp
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CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

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CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest addition to its enterprise software platform.
KING OF PRUSSIA, Pa., Sept. 27, 2024 /PRNewswire/ — CluePoints continues to transform clinical trial review and leverage its industry-leading software to enhance the interrogation, analysis and presentation of data with the launch of its latest application, Medical & Safety Review (MSR).

The tool simplifies and streamlines the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history. This not only improves efficiency and communication in medical oversight, but also elevates patient safety, differentiating MSR as a smarter and unique solution.
Designed by, and for Medical and Safety Reviewers, MSR converts the manual analysis of patient outcomes, which can be prone to inefficiency and error, into an accurate, efficient process. MSR tackles time-consuming study preparation for specific visualizations by featuring a comprehensive standard visualization library as well as the ability to copy and reuse dashboards across different studies, enabling the identification of outlying values, change tracking, and improved communication for smarter clinical trials.
Other benefits of MSR include:
Enhanced medical review efficiency and reduced human errors via automated checksReduced time spent by clinical and data management teams in reviewing dataImproved collaboration with integrated review workflows across departmentsEnsured record quality and accountability with comprehensive change trackingDriving faster decision making with the proactive detection of trends and safety issuesEnsuring regulatory compliance with rule-based detection and user assignmentsAndy Cooper, Chief Executive Officer at CluePoints, commented, “We are thrilled to announce the launch of Medical & Safety Review to our growing product offerings. MSR is the latest application addition to the CluePoints platform, which includes products such as Risk-Based Quality Management (RBQM) and our Site Profile & Oversight Tool (SPOT). Together, they provide a comprehensive approach to clinical trial optimization, enhancing data integrity, ensuring regulatory compliance, and accelerating drug development. The creation of MSR ensures a more streamlined review process while prioritizing patient safety at every step and empowers medical teams to swiftly identify outliers, track data changes, and improve communication.”
To learn more about CluePoints’ award-winning solutions, please visit www.cluepoints.com
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
 

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