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Adagene Announces Clinical Trial Collaboration With Merck to Advance Two Anti-CTLA-4 Monoclonal Antibody Programs (ADG116 and ADG126) in Combination Therapy with KEYTRUDA® (pembrolizumab)

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SAN FRANCISCO, July 22, 2021 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced that it has entered into the clinical trial collaboration and supply agreement with Merck (known as “MSD” outside the United States and Canada), the leader among top immuno-oncology (IO) drugs on the market. The agreement includes two open-label, dose escalation and expansion clinical studies to evaluate Adagene’s anti-CTLA-4 monoclonal antibody (mAb) product candidates, ADG116 and ADG126, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced/metastatic solid tumors.

“This collaboration with Merck and the advancement of our global clinical studies represent an important milestone in our comprehensive CTLA-4 clinical development program,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “Our AI driven platforms have generated two highly differentiated CTLA-4 targeting molecules, ADG116 and ADG126. ADG116, our NEObody™ CTLA-4 candidate, is designed with strong antibody-dependent cellular cytotoxicity (ADCC) and softened T cell activation which combined, leading to increased potency with an improved safety profile. Our SAFEbody™ candidate ADG126 effectively limits on-target off-tumor toxicities in normal tissues and is designed for a superior systemic safety profile at efficacious dose levels with a significantly enhanced therapeutic window to overcome existing issues associated with current anti-CTLA-4 therapies.”

Dr. Luo continued, “Although we believe that ADG116 and ADG126 have great promise as single agents, combining with KEYTRUDA may unleash the potential of dual PD-1/CTLA-4 blockade, overcoming the safety profile limitations seen historically with this combination while also modulating different T cell populations to drive new immune functions and synergies not achievable through conventional monotherapies. Our extensive preclinical and early strong clinical data support this strategy, and we look forward to combining our anti-CTLA-4 therapeutics with anti-PD-1 checkpoint inhibitors such as KEYTRUDA to fulfill the potential of this combination therapy approach. We are fortunate to have the opportunity to explore this combination with Merck and tackle two of the most potent immunotherapy targets.”

“We are extremely pleased to partner with Merck to explore the therapeutic potential of ADG116 and ADG126 in combination with KEYTRUDA, as this collaboration represents an important milestone for Adagene, and for patients with advanced/metastatic solid tumors,” said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. “ADG116 program is at the 3 mg/kg dose level now which is where the commercial CTLA-4 therapy had been approved previously in mono and combination for specific indications. We expect to see differentiation going forward of our programs.”

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

About CTLA-4 Clinical Development Program

ADG 116-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG116 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. The study will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG116 in combination with KEYTRUDA with dose escalation planned for up to 10 mg/kg. The study builds on encouraging signs of pharmacodynamic (PD) markers, favorable pharmacokinetic (PK) profile, strong early clinical data of the ADG116-1003 trial, extensive preclinical and safety tolerability data and successful Safety Review Committee meetings. In the ADG116-1003 trial, ADG116 has been well tolerated in 17 patients, with no dose-limiting toxicities or unexpected safety signals. No drug related Grade 2, Grade 3 or Grade 4 toxicities have been observed. Dosing for three additional patients has been completed in the 3 mg/kg cohort, for a total of 17 patients treated to date.

ADG 126-P001: The Phase 1, open-label, dose escalation and cohort expansion study of ADG126 combined with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple sites in Asia and the United States. It will evaluate the safety, tolerability, and recommended Phase 2 dose for ADG126 in combination with KEYTRUDA with dose escalation planed for up to 10 mg/kg. The study builds on encouraging preclinical data, demonstrating ADG126 was well tolerated at doses up to 200 mg/kg, with an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD-1 and other therapies. In the ADG126-1001 trial, dose limiting toxicity (DLT) evaluation has been completed in six patients in the 0.1 and 0.3 mg/kg cohorts.

About Adagene
Adagene Inc. (Nasdaq: ADAG) 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 the therapeutic potential of ADG116 and/or ADG126 in combination with pembrolizumab to treat patients with advanced/metastatic solid tumors, data from the ADG116 and/or ADG126 clinical trials, clinical development plans of ADG116 and/or ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of ADG126. 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 the potential failure of the combination of ADG116 and/or ADG126 and pembrolizumab to demonstrate safety and/or efficacy in the Phase 1 open-label, dose escalation and expansion studies; the clinical results for Adagene’s 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:
Tony Russo
Russo Partners LLC
212-845-4251
[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

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

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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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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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