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Adagene Announces Clinical Advancement for ADG116

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-NEObody™ product candidate ADG116 has been well tolerated in ongoing Phase 1 clinical trial- 
-Promising pharmacodynamic biomarker signals demonstrate clinical proof of mechanism-
-Poised for global expansion-

SAN FRANCISCO and SUZHOU, China, March 29, 2021 (GLOBE NEWSWIRE) — Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced the interim dose-escalation data up to 0.3 mg/kg in its ongoing Phase 1 clinical trial in Australia evaluating the safety and tolerability of ADG116 in patients with advanced/metastatic solid tumors. ADG116 is a fully human, anti-CTLA-4 monoclonal antibody (mAb), designed to target a unique conserved epitope of CTLA-4 and utilizes Adagene’s proprietary NEObody platform technology. ADG116 is designed to balance safety and efficacy through a novel mechanism of action; ADG116 maintains its original physiological function via partial blocking of CTLA-4 ligand binding, and in conjunction, depletes Treg in the tumor microenvironment via strong antibody-dependent cellular cytotoxicity (ADCC).

Interim data for the ongoing Phase 1 clinical trial:

  • Safety: Analysis of all safety data generated to date demonstrates that ADG116 has been well-tolerated in more than 10 patients with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 3 and Grade 4 toxicities have been observed.
  • Notable findings in pharmacodynamics: A dose-dependent change in CD8+ and CD4+ TEM / Treg ratios, important pharmacodynamic (PD) biomarkers indicating immune activation, was observed for patients dosed by ADG116. In particular, a patient, refractory to prior pembrolizumab therapy (> 25 cycles), demonstrated striking increases in T and NK cells, and CD8+ and CD4+ TEM / Treg ratios. The Grade 1 treatment-related pruritus of this patient is a clinical symptom consistent with immune-mediated action of ADG116 treatment.
  • Pharmacokinetics: The terminal half-life of ADG116 was within the normal range of IgG1 based antibodies.
  • Clinical proof of mechanism: The Phase 1 dose escalation data demonstrates the clinical proof of mechanism for ADG116 in targeting CTLA-4, consistent with preclinical observations for the potency of ADG116 starting from 0.03 to 0.3 mg/kg.

“We are encouraged by the positive PD marker signals and safety data,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “It is particularly striking to observe immune activation biomarkers at 0.03 mg/kg, especially in the patient refractory to prior pembrolizumab therapies. We believe ADG116 has the potential to overcome the limitations of anti-CTLA-4 checkpoint inhibitors, extending the market potential beyond current anti-CTLA-4 inhibitors in both monotherapy and combination settings. Our highly differentiated anti-CTLA-4 therapeutics hold the potential to improve the clinical benefits by expanding clonal diversity, infiltrating into cold tumors, and treating patients resistant/refractory to current immuno-therapies.”

“We look forward to developing a comprehensive clinical program to evaluate each of our anti-CTLA-4 assets,” continued Dr. Luo. “We will leverage the modality-specific features demonstrated in the preclinical setting, that enable high-fidelity translation into the clinic by targeting unique, highly conserved epitope of CTLA-4 with broad species cross-reactivity. We remain committed to maximizing the full potential of our unique anti-CTLA-4 approach.”

The progression of the Phase 1 dose-escalation trial to the 5th dose, a 0.3mg/kg dose level, builds on encouraging signs of PD markers, normal PK data, strong early clinical data, extensive preclinical and safety tolerability data and a successful Safety Review Committee meeting. Multiple clinical sites are currently open in Australia. In this ongoing Phase 1 clinical trial of ADG116 in patients with advanced/metastatic solid tumors, no dose-limiting toxicity (DLT), treatment-related serious adverse events (SAEs), colitis or hepatitis have been observed. With favorable clinical data to date, Adagene looks forward to expanding the ongoing global Phase 1 trial, with the acceptance of revised study protocol by FDA to expand the trial in the U.S. Adagene has also obtained confirmation from China NMPA to proceed with revised protocol submission at higher starting dose than that in the original submission. Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04501276.

About ADG116
ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using NEObody technology. ADG116 is a differentiated anti-CTLA-4 approach, which leverages Adagene’s Dynamic Precision technology to target a conserved epitope with broad species cross-reactivity for translational fidelity and a unique CTLA-4 mechanism of action. In preclinical studies, ADG116 was observed to have softer CTLA-4 ligand blocking and stronger ADCC for depleting regulatory T-cells than ipilimumab. In a head-to-head in vivo efficacy study, ADG116 was observed to have at least a five-fold greater preclinical antitumor activity in comparison with ipilimumab. In preclinical studies, ADG116 was well tolerated in rats and cynomolgus monkeys in four-week repeat-dose GLP toxicology studies at doses up to 30 mg/kg, and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent (showing initial response at 0.02mg/kg, and complete response at 0.1 mg/kg for tumor size of ~100mm3 in sensitive tumor models) and in combination with other therapies.

About Adagene
Adagene Inc. is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science.

For more information, please visit: https://investor.adagene.com.

Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding data from the ADG116 preclinical studies and Phase 1 clinical trial, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones, and commercialization of ADG116. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Investors Contact
Raymond Tam
Adagene
86-512-8777-3626
[email protected]

Bruce Mackle
LifeSci Advisors
646-889-1200
[email protected]

Media Contact
Annie Starr
6 Degrees
973-768-2170
[email protected]

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Artificial Intelligence

XtalPi Unveils XtalGazer: A Comprehensive AI-Driven Polymorph Selection Platform

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xtalpi-unveils-xtalgazer:-a-comprehensive-ai-driven-polymorph-selection-platform

CAMBRIDGE, Mass., March 28, 2024 /PRNewswire/ — XtalPi Inc., a leading global technology company in integrating artificial intelligence (AI) and robotics to advance the discovery of groundbreaking medicine and innovative materials, announced today the launch of its proprietary comprehensive solid form discovery and selection platform, XtalGazer. This advanced platform aims to significantly improve the polymorph selection process for the pharmaceutical industry by integrating AI- and automation-powered experimental and computational approaches.

XtalGazer provides a total solution for delivering high-quality polymorph screening and selection methods to expedite drug development and mitigate risks. It represents a paradigm shift in solid-state research, moving from the traditional trial-and-error approach to a data-driven, design-led methodology. The platform provides an expansive suite of foundational tools to accelerate polymorph discovery, characterization, and selection process, empowering pharmaceutical companies to conduct thorough research with less active pharmaceutical ingredient (API) in shorter development cycles.
A key component of XtalGazer is XtalCSP, a crystal structure prediction platform to perform global searches of crystal structures for target molecules and the other optional components in the corresponding searching space, offering a deep insight into possible stable forms. Furthermore, crystallization strategy recommendations will provide AI-backed experimental design to help avoid human bias. XtalGazer also utilizes MicroED to rapidly elucidate crystal structures from powder samples, reducing the need for growing single crystals.
XtalPi’s launch of XtalGazer marks another significant step in the company’s ongoing exploration of solid-state research. From crystal structure prediction platforms being one of the first products to launch at XtalPi, to today’s comprehensive polymorph selection platform, XtalPi will keep fulfilling its promise to solving challenging problems in this space. XtalPi will continue to deliver faster, more accurate, and more comprehensive approaches to building an ecosystem for the R&D process in solid-state, pre-formulation and crystallization.
For more information about XtalPi, please visit www.xtalpi.com.
About XtalPi:
XtalPi is an innovative technology company powered by artificial intelligence (AI) and robotics. Founded in 2015 on the MIT campus, XtalPi is dedicated to driving intelligent and digital transformation in the life science and new materials industries. With tightly interwoven quantum physics, AI, cloud computing, and large-scale clusters of robotic workstations, XtalPi offers a range of technology solutions, services, and products to accelerate and empower innovation for biopharmaceutical and new materials companies worldwide.
Media Contact: Vivienne [email protected]
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ICIS and Base Oil News Announce Partnership to Enhance Market Insights

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icis-and-base-oil-news-announce-partnership-to-enhance-market-insights

LONDON, March 28, 2024 /PRNewswire/ — ICIS, a global source of commodity intelligence, is pleased to announce a strategic partnership with Base Oil News, a premier news outlet founded by industry expert Iain Pocock that provides in-depth coverage of the base oils and lubricants market. This collaboration marks a significant milestone in the dissemination and exchange of critical market data and insights.

With more than two decades of journalism experience at Bloomberg, Reuters, and Argus Media, Iain Pocock brings unparalleled expertise to this partnership. His deep understanding of illiquid energy markets makes him a credible and influential figure in the industry. Since November 2023, Iain has been working closely with ICIS to share and exchange valuable data and insights, enhancing the services both platforms offer to the base oils and lubricants market.
Through the collaboration, Iain integrates ICIS’ extensive content and data resources in Base Oil News market coverage. In return, he contributes market insights to ICIS News, including expert and exclusive analysis of supply and demand dynamics, price margins, and other critical market drivers. This exchange ensures that subscribers of both ICIS and Base Oil News have access to the most comprehensive, timely, and accurate market information, empowering them to make informed decisions.
“It’s a very exciting partnership – where we leverage each other’s strengths and provide actionable insights to our customers,” said Iain Pocock, Founder of Base Oil News. “The market is the winner.”
“As ICIS is already the world’s most trusted pricing benchmark for base oils, this collaboration with Iain Pocock and Base Oil News provides an even stronger and deeper service to our customers,” said Stephen Burns, Editorial Director at ICIS. “Iain’s expertise and extensive industry connections are invaluable, and we have established a fruitful partnership that benefits the market at large.”
For the latest insights from Iain Pocock on ICIS News, visit ICIS News.  
About ICIS
ICIS – Independent Commodity Intelligence Services – helps businesses through seamlessly delivering data and analytics, across the chemical, fertilizer and energy markets. A trusted source and benchmark for price information and insight across key commodities markets worldwide. Our independent, transparent market intelligence informs thousands of quality decisions every day, taking the pressure out of negotiations and giving customers space for more innovative thinking, through published datasets including price assessments, price forecasts, supply and demand fundamentals and more.
Over 150 years of shaping the world by connecting markets to optimise the world’s valuable resources. With a global team of more than 600 experts, ICIS has employees based in London, New York, Houston, Karlsruhe, Milan, Mumbai, Singapore, Guangzhou, Beijing, Shanghai, Dubai, Sao Paulo, Seoul, Tokyo and Perth.
ICIS is part of RELX, a FTSE15 company with a market cap of £64bn and an employee base of over 30,000 experts across 40 countries.
About RELX
RELX is a global provider of information and analytics for professional and business customers across industries. The Group serves customers in more than 180 countries and has offices in about 40 countries. It employs approximately 30,000 people of whom almost half are in North America. RELX PLC is a London listed holding company which owns 52.9% of RELX Group. RELX NV is an Amsterdam listed holding company which owns 47.1% of RELX Group. The shares are traded on the London, Amsterdam and New York Stock Exchanges using the following ticker symbols: London: REL; Amsterdam: REN; New York: RELX and RENX. Total market capitalisation is approximately £64bn | €75bn | $81bn.
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Trianz Welcomes Israel Abraham as Vice President of Services for Extrica.ai – The Data to AI Platform

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SANTA CLARA, Calif., March 28, 2024 /PRNewswire/ — Digital transformation technology & services company Trianz is pleased to announce the appointment of Israel Abraham as Vice President of Extrica Platform Services.

Trianz has embarked on a transformative journey, redefining its value proposition with an ‘IP Led’ model, with a commitment to deliver the fastest time to value, lowest human dependence, and highest ROI. Central to this approach are our hyper-automated platforms, Concierto.Cloud, Extrica.AI, and Pulse, driving industry-leading transformations in cloud, data and analytics, AI, and the digital workplace.
Israel Abraham is a very well-known pioneer and industry leader in AI, data management, and analytics systems, with over three decades of experience. He joins as the services leader for Extrica- the Trianz Data to AI platform, which productizes data, provides data a face and purpose, and accelerates time to insights and AI by 50% or more. In the role of Extrica Services leader, Israel will lead the shaping, visioning, and delivery of Extrica.ai based enterprise wide datamesh, BI, and AI solutions for customers worldwide.
“We are thrilled to welcome Israel Abraham to the Trianz family,” said Sri Manchala, CEO of Trianz and author of Crossing the Digital Faultline. “He is a leader in modernization as well as conceptualization of data platforms anew. Israel’s prior background in the industry with financial services and insurance giants underscores our commitment to securing top-tier talent that brings real-world experiences and needs to our technology platforms. As we continue to broaden our footprint in the digital transformation space, Israel’s visionary leadership and practical experience will serve as the cornerstone in accelerating insights and AI to deliver transformative value to our clients.”
Having played pivotal roles in highly reputed and large organizations such as Liberty Mutual Insurance, MassMutual, Safeco, and CNA Insurance, Israel has garnered recognition as a seasoned leader in big data and AI cloud implementations. His accolades include the prestigious 2014 Ventana Research IT Innovation Award, the 2009 Informatica MDM Innovation Award, and three filed Data Engineering patents in the last four years.
“Trianz has been at the forefront of digital innovation, and Extrica.ai is a paradigm shifting data to AI platform that completely changes how analytics and AI are delivered- much faster, taking business ahead of change. I am excited to scale the adoption of the Extrica platform, which has attracted attention from giants across the industry and hyperscalers,” said Israel Abraham. “I look forward to engaging with customers, bringing my own experiences, and collaborating with the talented team at Trianz to further enhance the capabilities of the Extrica Platform Services to transform data & AI strategies, execution, and outcomes for customers.”
About Trianz
Trianz is a leading-edge technology platforms and services company that accelerates digital transformations at Fortune 100 and emerging companies worldwide in data & analytics, digital experiences, cloud infrastructure, and security. Our ‘IP Led Transformations’ approach, informed by insights from a recent global study spanning 20+ industries and 5000+ companies, addresses challenges posed by the rapid pace of AI-driven transformation, digital talent scarcity, and economic uncertainty. Our IP and platforms, including Concierto, Extrica, and Pulse, revolutionize cloud adoption, data analytics, and AI insights, empowering organizations to navigate the complexities of digital transformation seamlessly.
Founded in California and with an organization of over 2,000 associates across the United States and India, Trianz is a Premier Partner of AWS, consistently rated #1 by clients for value delivery over the past five years. Trianz has been ranked as one of the best Consulting Firms by Forbes and has been certified as a Great Place to Work for three years in a row. To learn more about Trianz, email [email protected] or visit www.trianz.com.
Watch Trianz CEO Sri Manchala’s insightful interview with Bloomberg on Partner | Crossing The Digital Faultline & Leading Towards Transformative Success – YouTube and delve deeper into his book Crossing the Digital Faultline at Crossing the Digital Faultline | Trianz.
Trianz Media [email protected] +1-408-387-5800
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View original content:https://www.prnewswire.co.uk/news-releases/trianz-welcomes-israel-abraham-as-vice-president-of-services-for-extricaai–the-data-to-ai-platform-302102589.html

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