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Adagene Presents Preclinical Data from Lead SAFEbody™ Program, ADG126, at the American Association for Cancer Research (AACR) Annual Meeting 2021

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SAN FRANCISCO and SUZHOU, China, April 13, 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 updated preclinical data from its lead SAFEbody™ program, ADG126, are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2021.

“There is a critical unmet need for new anti-CTLA-4 therapies, and we are encouraged by the data generated to date, which demonstrate ADG126 has the potential to overcome the severe immune-mediated adverse reactions associated with the class,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “By leveraging our SAFEbody platform technology, designed to precisely and very efficiently mask the antibody binding interface and activate specifically within the tumor microenvironment, our preclinical data continues to highlight the opportunity to effectively deliver treatment; ADG126 has demonstrated superior systemic safety profile at efficacious dose levels with a significantly enlarged therapeutic index (TI). Our ongoing global Phase 1 trial is expected to provide clinical validation for our SAFEbody platform and our SAFEbody product candidate, ADG126. We have successfully finished DLT evaluation of 3 patients at 0.1 mg/kg of ADG126 and remain on track to report topline safety and efficacy data in the second half of 2021.”

A copy of the poster presentation, entitled “A Novel Anti-CTLA-4 Checkpoint Inhibitor Prodrug to Address On-target Off-tumor Toxicity for Cancer Immunotherapy,” is available on the AACR website and is also available for download via our website (https://www.adagene.com/).

The data presented show:

  • Notable Findings: ADG126 demonstrated an impressive safety margin while maintaining its potent antitumor activity.
  • Unique Epitope with Broad Species Cross-Reactivity: ADG126 targets a conserved epitope of CTLA-4 with broad species cross-reactivity and is an activatable prodrug for tumor suppression in multiple syngeneic mouse models in single and combination therapies.
  • Differentiated Mechanism of Action: Although the activated ADG126 is softer in blocking CTLA-4 binding with its ligands than ipilimumab, the activated ADG126 exhibited more potent antibody dependent cellular cytotoxicity (ADCC) in the tumor microenvironment.
  • Intra-Tumoral Treg Depletion: Treg cells in tumor tissues exhibited higher CTLA-4 expression than in peripheral tissues and were efficiently depleted upon treatment with ADG126 in the immune-competent mouse syngeneic colon tumor model.
  • Human T-Cell Activation in Vitro: Activated ADG126 potently enhanced T-cell activation, measured by IL-2 secretion, whereas the masked ADG126 did not.
  • In Vivo Monotherapy Antitumor Activity: ADG126 exhibited potent antitumor activity as a single agent in different immune-competent syngeneic mouse tumor models.
  • In Vivo Combination Antitumor Activity: ADG126 combined synergistically with other IO agents, such as anti-PD-1 antibody, to inhibit tumor growth in vivo. Combination therapy significantly slowed tumor growth and caused complete regression in 50% of Lewis lung cancer mouse models.
  • Safety and Tolerability: ADG126 was well tolerated in animals suggesting the potential for high therapeutic index. The highest non-severely toxic dose (HNSTD) was determined to be 200 mg/kg/dose, which is one of the highest reported HNSTD for anti-CTLA-4 antibodies.

About ADG126
ADG126 is a fully human antagonistic mAb targeting a novel epitope of CTLA-4 and has been shown to specifically deplete regulatory T-cells in tumors. ADG126 is Adagene’s lead SAFEbody™ product candidate. The SAFEbody technology, developed using Adagene’s AI-powered platform, enables binding of an antibody to a specific target only after conditional activation of the antibody in target tissues.

In preclinical studies, ADG126 was well tolerated in cynomolgus monkeys and demonstrated 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.

Unlike anti-PD-1/PD-L1 check point inhibitors, anti-CTLA-4 is known for its dose-dependent clinical response in single and combination therapies, which is severely limited by the narrow therapeutic window available to current anti-CTLA-4 therapies.  The large safety margin shown by ADG126 GLP toxicology studies of up to 200 mg/kg in targeting CTLA-4 will make it possible to dose patients for their optimal clinical benefits in single and combination therapies.

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 data from the ADG126 preclinical studies and Phase I clinical trial, 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 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] 

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

First Comprehensive Report on Public Web Data Released by Bright Data

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Reveals necessity in every industry
NEW YORK, April 23, 2024 /PRNewswire/ — Released today, The State of Public Web Data Report 2024, details a comprehensive analysis on how organizations leverage public web data to drive innovation, enhance customer experience, and develop AI models.

Bright Data commissioned an independent third-party to carry out the first survey of this kind which details the emergence of public web data as the most valued data type. Nearly every organization surveyed uses and benefits from public web data through quicker decision-making, boosting revenue, and meeting customer needs.
The need for public web data in AI is clear in all industries, with more than half of respondents using public web data to build AI models for customer service or to meet internal needs such as fraud detection and risk assessment.
Although necessary to build AI machines, 72% of respondents are worried that public web data will no longer be accessible in the next 5 years. The lack of a legal framework to protect this data emerged as a top concern.
Other key insights from the report:
89% of respondents recognize public web data is crucial or very important to the global economy.82% of respondents say public web data is critical to the future of their organization.79% of respondents agree that large organizations and or big tech hide too much of their public web data.88% of respondents believe public web data is critical for the development of AI models.”Our findings reveal a clear consensus among industry leaders: leveraging public web data is key to unlocking growth and fostering innovation,” said Or Lenchner, CEO of Bright Data. “Public web data is not a ‘like to have,’ it’s a ‘must have’ to conduct business and maintain a competitive market. We understand from our own experience with 20,000 customers that once a business realizes the potential of public web data they will look to discover new ways to leverage this tool to lead against the competition.”
About Bright Data: Bright Data is the #1 web data platform. Fortune 500 companies, academic institutions, non-profits, and small businesses rely on Bright Data’s solutions to collect public web data in the most efficient, reliable, and flexible way to make faster, more informed business-critical decisions.
Contacts:[email protected]
Logo – https://mma.prnewswire.com/media/2276620/Bright_Data_logo__1044x234_Logo.jpg 

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OSIA becomes an official International Telecoms Union (ITU) standard

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ITU Standardization Sector (ITU-T) Recommendation X.1281 – APIs for interoperability of identity management systems
BRUSSELS, April 23, 2024 /PRNewswire/ — The Secure Identity Alliance (SIA) announced today that its OSIA specification, is recognized as international standard by the International Telecommunication Union’s Telecommunication Standardization Sector (ITU-T). This milestone establishes OSIA as official ITU standard (ITU-T Recommendation) for the global infrastructure of information and communication technologies (ICT).

The specification that is now an ITU-T Recommendation is: ITU-T X.1281 – APIs for interoperability of identity management systems.
ITU-T is the standardization arm of ITU, the United Nations specialized agency for ICT. The Secure Identity Alliance specifications were approved as official ITU-T Recommendations by ITU members including 193 countries and the world’s front-running ICT companies on 1st March 2024. The new ITU-T Recommendation is under the responsibility of ITU’s standardization expert group for security, ITU-T Study Group 17.
“We are very proud that the OSIA specification is recognized as an international standard by ITU-T. This milestone demonstrates the maturity of OSIA and its potential to foster interoperability and promote fairness in the identity management systems market,” said Debora Comparin, Chair of the OSIA Initiative.
Prof. Heung Youl Youm, Chairman of ITU-T Study Group 17, said, “The recognition of the OSIA specification as an official ITU-T Recommendation underscores its critical contribution to the advancement of global ICT infrastructure. We are thrilled about the ongoing collaboration between ITU-T SG17 and the SIA, aimed at developing standards for secure identity management.”
“As Editor of the OSIA standard in the ITU-T Study Group 17 Q10, I am pleased to have contributed to this successful recommendation by the ITU,” said Abbie Barbir, Rapporteur for ITU-T’s working group on ‘Identity management and telebiometrics architecture and mechanisms’ (Q10/17). “The collaboration with the SIA continues on OSIA and other structuring initiatives and standards development.”
Engr Abisoye Coker-Odusote, CEO, National Identity Management Commission (NIMC), Nigeria & Chair of the OSIA Advisory Committee, said, “As the Chair of the OSIA Advisory Committee, comprised exclusively of government representatives, we take great pride in our five years of collaboration guiding the working group in the development of the OSIA specification. OSIA establishes equal marketplace conditions, fosters collaboration, and ensures product compatibility post-mergers and acquisitions. The OSIA standardized interfaces drive innovation, enabling new local market models and reducing fraud within multiple ID systems. Additionally, OSIA addresses integrator/vendor lock-in, allowing governments to maintain control over their identity systems and pursue national development agendas seamlessly.”
“The Secure Identity Alliance has always supported standards and its members have contributed to thousands of standards globally, which are now used in the ICT market. Standards are key to unlock the full power of Identity to enable people, economy and society to thrive,” concluded Didier Trutt, Chairman of the SIA.
X.1281 is at publication stage and can be accessed here: https://www.itu.int/ITU-T/workprog/wp_item.aspx?isn=18778
OSIA v6.1.0. twin specification can be accessed here: https://osia.readthedocs.io/en/v6.1.0/index.html 
OSIA qualification programme can be accessed here: https://globalplatform.org/osia-qualification-program/
For more information on the Secure Identity Alliance and the OSIA Initiative, visit http://www.secureidentityalliance.org and www.osia.io
For more information on ITU-T SG 17 visit https://www.itu.int/en/ITU-T/studygroups/2022-2024/17/Pages/default.aspx.
About the Secure Identity Alliance:
Secure Identity Alliance (SIA) is a global non-profit association that serves as the voice for public and private actors and organizations active in the secure identity ecosystem and adjacent industries. SIA’s mission is to unlock the full power of identity so that people, economy, and society thrive. The association supports the development of the activities of its members across four broad pillars: Identity for Good, Outreach, Open Standards Development and Industry Services and Solutions. www.secureidentityalliance.org
About OSIA:
A digital public good, OSIA is an open standard set of interfaces (APIs) that enables seamless connectivity between building blocks of the identity management ecosystem – independent of technology, solution architecture or vendor.  More information at www.osia.io
Follow the Secure Identity Alliance at on X @secureidentity1 and LinkedIn at https://www.linkedin.com/company/secure-identity-alliance/ 
About ITU-T SG 17
The ITU Telecommunication Standardization Sector (ITU-T) is one of the three Sectors (branches) of the International Telecommunication Union (ITU). It is responsible for coordinating standards for telecommunications and Information Communication Technology such as X.509 for cybersecurity, Y.3172 and Y.3173 for machine learning, and H.264/MPEG-4 AVC for video compression, between its Member States, Private Sector Members, and Academia Members.
Logo: https://mma.prnewswire.com/media/2394623/OSIA_Logo.jpg
 

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SciBase will present at the Redeye Medtech Event on April 24th

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STOCKHOLM, April 23, 2024 /PRNewswire/ — SciBase Holding AB (“SciBase”) (STO: SCIB), a leading developer of augmented intelligence-based solutions for skin disorders will participate at the Redeye Medtech event.

On April 24 at CET 9.50 CEO Pia Renaudin will present the latest developments in SciBase at Redeye. The presentation is live broadcasted and can be followed at https://www.redeye.se/events/974326/redeye-theme-medtech-2 where the replay and the presentations will be available afterwards.
For additional information, please contact:Pia Renaudin, VD, tel. +46732069802, e-mail: [email protected]
Certified Advisor (CA):Vator SecuritiesTel: +46 8 580 065 99Email: [email protected]
About SciBase:
SciBase is a global medical technology company, specializing in early detection and prevention in dermatology. SciBase develops and commercializes Nevisense, a unique point-of-care platform that combines AI (artificial intelligence) and advanced EIS technology to elevate diagnostic accuracy, ensuring proactive skin health management.
Our commitment is to minimize patient suffering, allowing clinicians to improve and save lives through timely detection and intervention and reduce healthcare costs.
Built on more than 20 years of research at Karolinska Institute in Stockholm, Sweden, SciBase is a leader in dermatological advancements.
The company has been on the Nasdaq First North Growth Market exchange since June 2, 2015. Learn more at www.scibase.com. All press releases and financial reports can be found here: http://investors.scibase.se/en/pressreleases
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/scibase/r/scibase-will-present-at-the-redeye-medtech-event-on-april-24-th-,c3966053
The following files are available for download:
https://mb.cision.com/Main/12371/3966053/2751965.pdf
Redeye presentation
 

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