Artificial Intelligence

OncXerna Therapeutics Announces Final Results and New Xerna™ TME Panel Biomarker Data from a Phase 2 Trial of Bavituximab Plus Pembrolizumab in Patients with Previously Untreated Advanced Hepatocellular Carcinoma

Published

1 year ago

January 23, 2023

Bavituximab plus pembrolizumab combination achieved a 62.5% response rate in biomarker positive subgroup of hepatocellular cancer patients

Data reinforce the potential of Xerna TME Panel to substantially improve outcomes for patients

WALTHAM, Mass., Jan. 23, 2023 (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, announced final results from a Phase 2 trial of bavituximab plus pembrolizumab in patients with previously untreated advanced hepatocellular carcinoma and new biomarker data demonstrating that the Xerna™ TME Panel clearly identified trial participants more likely to benefit from treatment. The data were featured in a poster that was presented on January 20, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).

The biomarker results presented at ASCO GI are from a planned analysis of tumor biopsies using the Xerna TME Panel, a novel RNA expression-based diagnostic panel that uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). In the study featured in the ASCO GI poster, pre-treatment tumor biopsies were analyzed using the Xerna TME Panel and findings were correlated with objective tumor response to test the hypothesis that tumors with high immune scores (immune active or immune-suppressed TME subtypes [biomarker-positive]) are more likely to respond to bavituximab plus pembrolizumab than those with low immune scores (angiogenic or immune-desert TME subtypes [biomarker-negative]).

David Hsieh, M.D., Assistant Professor at University of Texas Southwestern Medical Center and lead investigator of the Phase 2 trial, commented, “Our newly reported clinical data in front-line liver cancer show a near doubling of response rate in the subset of patients classified as biomarker-positive by the Xerna TME Panel. The high response rate seen in these patients is rarely achieved in this challenging disease. Moreover, our patients are potentially more reflective of typical U.S.-based patients compared to those included in recent large, pivotal trials that enrolled the majority of their patients at sites outside of the U.S. We are therefore excited by the prospect of using this panel to optimize the care of patients with liver cancer.”

Key data featured in the ASCO GI poster are summarized below.

Best Overall Response N (%)	All Patients¹ N=28	Patients with Biomarker Data²
Best Overall Response N (%)	All Patients¹ N=28	All N=19	Biomarker + N=8	Biomarker – N=11
Complete response³	2 (7.1)	1 (5.3)	1 (12.5)	0 (0)
Partial response³	7 (25.0)	5 (26.3)	4 (50.0)	1 (9.1)
Stable disease	5 (17.9)	3 (15.8)	1 (12.5)	2 (18.2)
Progressive disease	14 (50.0)	10 (52.6)	2 (25.0)	8 (72.7)
Objective response rate	9 (32.1)	6 (31.6)	5 (62.5)	1 (9.1)
Disease control rate	14 (50.0)	9 (47.4)	6 (75.0)	3 (27.3)

¹Analysis based on evaluable patients per protocol. ²All patients with available biomarker results; 9 patients did not have tissue available for testing and biomarker status could not be determined. ³Responses were confirmed by radiographic assessment no sooner than 4 weeks from the time of initial response.

Hagop Youssoufian, M.D., Chief Medical Officer of OncXerna Therapeutics and Adjunct Professor of Medicine at Brown University, commented, “The Xerna TME Panel has demonstrated remarkable consistency in identifying patients who are more likely to benefit from targeted and immune therapies across several malignancies. Although this was a proof-of-concept study, the responses noted in the biomarker-positive subgroup of patients in this lethal disease indicate substantial activity by comparison to the most active and contemporary combination therapies. This is the latest example of OncXerna’s longstanding commitment to utilize the Xerna TME Panel to bring the right medicines to the right patients.”

A copy of the ASCO GI poster, entitled: “A phase II clinical trial of the phosphatidylserine targeting antibody, bavituximab in combination with pembrolizumab in patients with advanced hepatocellular carcinoma,” will be available on the OncXerna website following the conclusion of the ASCO GI Symposium.

About the Phase 2 Trial

The trial featured in the ASCO GI poster was an investigator-sponsored, Phase 2, single arm study conducted at the University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center. The trial evaluated the combination of bavituximab and pembrolizumab in previously untreated patients with advanced hepatocellular carcinoma (HCC). The primary objective of the study was to determine the overall response rate (ORR) of the studied combination in patients with advanced HCC. Results showed bavituximab plus pembrolizumab was well tolerated, with no new safety signals, and that the studied combination induced objective tumor response in a meaningful subset of trial participants. Analysis of tumor biopsies showed that the response rate was enhanced in Xerna TME biomarker positive patients, while higher progressive disease rates were observed in biomarker negative patients. For more information on the trial, see Clinicaltrials.gov Identifier: NCT03519997.

About Bavituximab

Bavituximab is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials. 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. 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.

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 precision medicine oncology company developing novel therapies to treat solid tumors. Utilizing its innovative precision medicine platform (Xerna™), 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 the Xerna 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. OncXerna’s lead product candidate, navicixizumab, is a bispecific antibody that inhibits both DLL4 and VEGF and is currently being studied in ovarian cancer, triple negative breast cancer, and colorectal cancer. Another product candidate, bavituximab, is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials. 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.

Investor and Media Contact:

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

Related Topics:AI Artificial Intelligence Machine learning

Up Next

Elevator Safety System Global Market Report 2022: Stringent Regulations and Standards on Elevator Safety Drives Adoption

Don't Miss

Evaluating Perceptions and the Use of Immersive Technologies and the Metaverse

GlobeNewswire

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

Greater efforts urged on sci-tech cooperation

Published

26 mins ago

April 26, 2024

CISION (PR Newswire)

greater-efforts-urged-on-sci-tech-cooperation

BEIJING, April 26, 2024 /PRNewswire/ — A news report from China Daily:

Greater efforts are needed to strengthen international cooperation in science and technology, explore ways of jointly solving important global issues through technological innovation, and develop new quality productive forces, said officials, experts and company executives on Thursday in Beijing.
Addressing the opening ceremony of the 2024 Zhongguancun Forum, Vice-Premier Ding Xuexiang said China is willing to work with the international community to practice the concept of open, fair, just and nondiscriminatory international sci-tech cooperation, and to jointly build a global sci-tech community.
The country will explore a new model regarding mutually beneficial global cooperation in sci-tech innovation, and will break down barriers restricting the flow of knowledge, technology, talent and other innovative factors, to jointly create an open innovation ecosystem.
Yin Li, secretary of the Communist Party of China Beijing Municipal Committee, said the capital will ramp up efforts to improve its innovation capacities, accelerate the building of world-leading science and technology parks, increase investment in basic research and make breakthroughs in core technologies in key fields.
Data from the Ministry of Science and Technology showed that China’s research and development investment exceeded 3.3 trillion yuan ($455.4 billion) in 2023, up 8.1 percent year-on-year, and the spending on fundamental research reached 221.2 billion yuan, an increase of 9.3 percent over the previous year.
China’s strength in scientific and technological innovation has taken a major leap in recent years. Marco Aleman, assistant director-general of the World Intellectual Property Organization, said China is a powerhouse of innovation that contributes to global growth and sustainable development.
According to WIPO, the country stands as a global innovation leader, ranking 12th in the Global Innovation Index 2023, and it owned 24 of the top 100 science and technology clusters globally by the end of last year, ranking first in the world for the first time.
Quarraisha Abdool Karim, president of the World Academy of Sciences, said ensuring a sustainable future through partnership and cooperation creates an opportunity for all participants to explore new pathways toward achieving the United Nations’ Sustainable Development Goals.
Lei Jun, founder and CEO of Chinese tech company Xiaomi Corp, said the company will continue to step up investment in R&D and strive for breakthroughs in core technologies.
Photo – https://mma.prnewswire.com/media/2398374/Visitors_interact_a_humanoid_robot_opening_2024_Zhongguancun_Forum_Beijing.jpg

View original content:https://www.prnewswire.co.uk/news-releases/greater-efforts-urged-on-sci-tech-cooperation-302128473.html

Artificial Intelligence

Web O.No: Metaverse and Web 3.0 stunted by internet chaos, warn 87% of business leaders

Published

26 mins ago

April 26, 2024

CISION (PR Newswire)

Forrit report uncovers the internet is at breaking point, thanks to open source vulnerabilities, siloed web management systems, and poor website governance.
LONDON, April 26, 2024 /PRNewswire/ — A new study launched by Forrit, the next-generation, global content management system (CMS) provider, reveals that 89% of senior marketers and tech leaders are optimistic that Web 3.0 and the metaverse have the potential to revolutionise the way we interact with the web. However, the report, titled Web O.No: your business’ bleak online future and how to avoid it uncovered that 87% believe the current state of the internet will stunt these innovations – and none of the respondents have websites that are currently equipped for this transformative new internet era.

As we near the 31st anniversary of the World Wide Web’s entry into the public domain, UK business decision-makers unanimously agreed that “the Internet today is a mess,” citing security flaws, vulnerabilities with open source web management systems, ungoverned websites, and multiple layers of legacy CMS systems.
Despite the report focusing on heavily regulated industries, financial services, utilities, and the legal sector, over half of the respondents (57%) revealed they have website security flaws. They also admitted customers would lose trust if they were exposed. Security vulnerabilities were most prevalent among those who run their websites on open source solutions, rising to 79% in this group. Expert respondents underscored the specific risk of open source plug-ins. Created by multiple third-party developers, they leave websites open to malicious compromise.
Beyond cyber-attacks, the report highlights the heightened risk of outages, dysfunctional interfaces, and hazardous content hidden within neglected pages of reputable websites. The latter is a risk for those operating multiple website management (CMS) systems – a common practice among the participants. Shockingly 44% admitted they don’t have control of the website content as a direct result of this practice.
With the internet spiralling out of control, Forrit labels this chaotic online future Web O.No.
Peter Proud, CEO and Founder, Forrit, explains the role of composable CMS platforms in putting the brakes on this doomsday scenario, “Forget Web 3.0, we’re heading towards Web O.No – a grim reality of an internet unfit for purpose unless we act now. It’s time to stop layering on outdated, vulnerable web management systems, which exacerbate the problem. Embracing a next-generation composable web management platform would introduce a new era of security, flexibility, and scalability for the internet, empowering businesses to embrace the future.”
The respondents reinforced this sentiment, with 89% asserting that composable architecture would empower their organisation to future-proof their digital infrastructure. This includes granting them the flexibility to adopt AI into the website—a capability that is inhibited by their current web management system, according to 72% of respondents.
Gary Roberts, CRO, Forrit, underscores this significance: “Your website management platform (CMS) should be an enabler of digital innovation, not a barrier. Embracing composable web architecture removes the current barriers, providing a clear pathway to the future – whether that’s the metaverse, Web 3.0, or any other pioneering tech advancement as yet undiscovered.”
Click here to download Forrit’s report – Web O.No: your business’ bleak online future and how to avoid it.
About ForritUK-based, global content management system provider, Forrit, has been helping large businesses in highly-regulated industries keep their web estate secure, simple-to-scale and easy-to-manage, for the last 10 years.
Our mission? To allow IT and marketing to manage their digital estate in perfect harmony. Through Forrit’s intuitive UI, low code CMS and content management configuration platform (Service Delivery Hub), the CMO and CTO can take joint control of their web estate.
An Azure-native solution, through which businesses can leverage any and all Azure Cloud Services, including AI-powered translation and automated migration, Forrit CMS is future proof and can be scaled or de-scaled as needed.
Sound technical? Not at all. Forrit’s platform requires no prior Azure knowledge or technical expertise to get everything needed from it. The plus to this, the strain is taken off the IT team, and the marketing team can create unrivalled digital experiences and manage content with ease.
With enterprise-grade security to top it off, Forrit’s cloud-native CMS helps businesses simplify their workflows, streamline their marketing efforts and scale at speed, securely.
About the researchCensuswide conducted the research with 505 UK IT and marketing decision-makers between 01.03.24 and 12.03.24. Censuswide abides by and employs members of the Market Research Society, which is based on the ESOMAR principles, and is a member of The British Polling Council.

View original content:https://www.prnewswire.co.uk/news-releases/web-ono-metaverse-and-web-3-0-stunted-by-internet-chaos-warn-87-of-business-leaders-302127761.html

Artificial Intelligence

Identity Governance & Administration Market Projected to Reach $24.42 billion by 2030 – Exclusive Report by 360iResearch

Published

6 hours ago

April 26, 2024

CISION (PR Newswire)

PUNE, India, April 25, 2024 /PRNewswire/ — The report titled “Identity Governance & Administration Market by Component (Services, Solution), Modules (Access Certification & Compliance Control, Access Management, Identity Lifecycle Management), Organization Size, Deployment, Vertical – 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 $8.46 billion in 2023 to reach $24.42 billion by 2030, at a CAGR of 16.34% over the forecast period.

“Navigating Global Identity Governance With Key Strategies for Digital Security and Compliance”
Identity governance and administration (IGA) has emerged as a critical policy-driven approach aimed at fortifying digital identities within organizations, ensuring that proper access is provided to the right individuals for valid reasons. Across the globe, the demand for IGA solutions is on the rise, driven by the need to tackle sophisticated cyber threats, comply with stringent data protection laws, and adapt to the digitization wave sweeping through industries. Challenges include integrating these solutions with pre-existing IT frameworks, primarily in organizations reliant on legacy systems. The North American market, led by the United States and Canada, is at the forefront of this expansion, embracing technological advancements and stringent regulatory standards. Meanwhile, the Europe, Middle East, and Africa (EMEA) region is navigating its unique landscape, with the EU focusing heavily on compliance through GDPR and the Middle East and Africa gradually recognizing the value of digital security. The Asia-Pacific region is witnessing a significant uptrend in IGA solutions adoption, spurred by digital transformation initiatives and cybersecurity awareness, with China and India playing pivotal roles. This global perspective highlights the universal importance of IGA in today’s digital era, highlighting the critical balance between innovation, security, and regulatory compliance in safeguarding digital identities.
Download Sample Report @ https://www.360iresearch.com/library/intelligence/identity-governance-administration
“Navigating the New Normal With The Crucial Role of Identity Governance in Securing Hybrid Work Environments”
As businesses globally embrace the fusion of remote and traditional office work, the need for secure, hybrid workspaces becomes paramount. The shift toward flexible working models, accelerated by the COVID-19 pandemic, highlights the importance of cybersecurity and accessibility in ensuring operational continuity and a better work-life balance. Identity governance & administration (IGA) systems emerge as essential tools within this evolving work landscape. They enable organizations to manage digital identities and access rights effectively, safeguarding sensitive data against unauthorized access across diverse working environments. By ensuring that only credentialed employees can access critical information, regardless of their physical location, IGA solutions stand at the forefront of maintaining cybersecurity compliance and operational integrity. This development signifies a growing demand for robust identity governance frameworks, ensuring businesses remain resilient and secure in remote work and beyond.
“Elevating Security and Efficiency in Organizations through Specialized Identity Governance & Administration Services”
Managed and professional services provide organizations with the specialized expertise necessary for optimizing the performance and security of identity governance & administration (IGA) systems, eliminating the need for such in-depth knowledge internally. Businesses benefit from advanced skills that enhance system functionality and safeguard sensitive data by outsourcing specific IGA tasks. From the initial stages of integration and implementation, ensuring seamless incorporation with existing infrastructures, to ongoing support and maintenance for consistent system reliability and up-to-dateness, these services form the foundation of effective IGA strategies. Furthermore, training and consulting play a pivotal role, equipping companies with the understanding and capability to utilize their IGA systems to the fullest. IGA solution is a critical technological tool designed to streamline the management of user access rights across organizations, bolstering security, operational efficiency, and compliance with regulatory standards. This comprehensive approach to IGA facilitates a more secure, efficient, and compliant organizational environment, empowering businesses to focus on core objectives and ensure their data remains protected.
Request Analyst Support @ https://www.360iresearch.com/library/intelligence/identity-governance-administration
“International Business Machines Corporation at the Forefront of Identity Governance & Administration Market with a Strong 7.09% Market Share”
The key players in the Identity Governance & Administration Market include Broadcom, Inc., SAP SE, Oracle Corporation, Microsoft Corporation, International Business Machines Corporation, 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 Identity Governance & Administration Market”
We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Identity Governance & Administration 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 Identity Governance & Administration 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/identity-governance-administration
“Dive into the Identity Governance & Administration Market Landscape: Explore 197 Pages of Insights, 654 Tables, and 26 Figures”
PrefaceResearch MethodologyExecutive SummaryMarket OverviewMarket InsightsIdentity Governance & Administration Market, by ComponentIdentity Governance & Administration Market, by ModulesIdentity Governance & Administration Market, by Organization SizeIdentity Governance & Administration Market, by DeploymentIdentity Governance & Administration Market, by VerticalAmericas Identity Governance & Administration MarketAsia-Pacific Identity Governance & Administration MarketEurope, Middle East & Africa Identity Governance & Administration MarketCompetitive LandscapeCompetitive PortfolioInquire Before Buying @ https://www.360iresearch.com/library/intelligence/identity-governance-administration
Related Reports:
Privileged Identity Management Market – Global Forecast 2024-2030Identity & Access Management Professional Services Market – Global Forecast 2024-2030Digital Identity Solutions 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
To learn more, visit 360iresearch.com or follow us on LinkedIn, Twitter, and Facebook.
Logo: https://mma.prnewswire.com/media/2359256/360iResearch_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/identity-governance–administration-market-projected-to-reach-24-42-billion-by-2030—exclusive-report-by-360iresearch-302126089.html