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Adagene Announces Publication at ASCO of Interim Monotherapy Dose Escalation Data Showing Compelling Safety Profile of Anti-CTLA-4 SAFEbody® ADG126, with Repeat Dosing Across Dose Levels

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       – First clinical data demonstrating potential of SAFEbody technology platform to create best-in-class therapeutics –

       – Additional data from ongoing ADG126 clinical program to be presented in second half of 2022, including safety in combination with anti-PD-1 therapies –

SAN DIEGO and SUZHOU, China, May 26, 2022 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced the publication of data showing the potential best-in-class safety profile of its anti-CTLA-4 monoclonal antibody (mAb), ADG126. Interim results from the Phase 1 dose escalation portion of an ongoing Phase 1b/2 trial of ADG126 are published in an abstract on the American Society of Clinical Oncology (ASCO) meeting website in conjunction with the 2022 Annual Meeting taking place in Chicago from June 3-7, 2022.

Key data in the abstract, titled “Phase 1 study of ADG126, a novel masked anti-CTLA-4 SAFEbody, that combines tumor-localized activation with strong Treg depletion and soft ligand blocking in patients with advanced solid tumors,” include the following:

  • In this dose escalation of 16 patients with advanced metastatic solid tumors, approximately one third received three or more lines of prior therapies, and approximately one third had progressed from immuno-oncology (IO) therapy. ADG126 was administered to this heavily pretreated patient population intravenously as monotherapy once every three weeks at doses up to 10 mg/kg.
  • No dose-limiting toxicities or treatment-related SAEs were observed and only Grade 1 treatment related adverse events (TRAEs) were reported with repeat dosing across all dose levels; fatigue (19%) and pruritis (13%) were most common.
  • Plasma pharmacokinetics (PK) were approximately linear and the activated ADG126 accumulated steadily during repeat dosing across different dose levels. As the first clinical data validating the SAFEbody precision masking technology, the approximately 1.7-fold increase in half-life of total ADG126 is reflective of prolonged exposures of activated ADG126 in the tumor microenvironment (TME).
  • In an early indication of antitumor activity, two heavily pretreated patients with cold tumors (one ovarian and one uveal melanoma) showed durable reductions in target lesions (over 20%) and increased CD8+ T cells post-dosing. After the seventh cycle of ADG126 treatment at 1 mg/kg the ovarian cancer patient also showed a 77% reduction in CA-125 levels, an established biomarker of clinical benefit for ovarian patients. This activity is likely due to the accumulation of activated ADG126 in the TME upon repeat dosing at 1 mg/kg. The uveal melanoma patient was resistant/refractory to prior IO-IO combination therapy, having progressed on the combination of nivolumab and ipilimumab.
  • At the data cut-off of February 15, 2022, stable disease was seen in 5/16 patients, including the ovarian cancer and uveal melanoma patients. Dose escalation in this trial continues at 20 mg/kg and dose expansion has started at 10 mg/kg.

Commenting on the findings, Dr. Gary Richardson, OAM, MBBS, FRACP, Group Director at Cabrini Health Research, Neil Beauglehall Endowed Chair, Medical Oncology Research, and Professor of Medicine at Monash University, Australia, said, “With the emerging clinical data evaluating this novel immunotherapy candidate ADG126, a masked anti-CTLA-4 SAFEbody, we have the opportunity to detangle safety from efficacy, and deeply understand the benefits of Treg depletion while we optimize anti-CTLA-4 therapy as a cornerstone of future therapy. Another exciting and surprising aspect of these interim findings is that we see early signals of efficacy in certain ‘cold’ tumors with SAFEbody ADG126, which further builds on prior clinical evidence with its parental antibody ADG116, targeting a unique epitope of CTLA-4 to enable not only a safer but potentially better therapy than the options we have available today.”

ADG126 SAFEbody applies precision-masking technology to the parental anti-CTLA-4 antibody, ADG116, for conditional activation in the TME to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies. Binding to the same unique epitope as ADG116, the masked ADG126 is designed to provide enhanced safety and efficacy profiles due to the combination of the potent Treg depletion in the TME and soft ligand blocking.

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“Following these monotherapy dose escalation results, we look forward to releasing further data in coming months to confirm if the strong safety profile of ADG126 is preserved in combination with anti-PD-1 therapy, consistent with our preclinical observations,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene.

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 Dynamic Precision Library (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. Follow Adagene on WeChat, LinkedIn and Twitter.

SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

Safe Harbor Statement

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This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical results of the product candidate, and Adagene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of Adagene pipeline candidates. 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.

Investor & Media Contact:
Ami Knoefler
Adagene
650-739-9952
[email protected]

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Legal Operations Leaders and General Counsels to Discuss Business-Critical Challenges at Legal Operations Exchange 2024

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LONDON, Sept. 30, 2024 /PRNewswire/ — The Legal Operations Exchange is set to return to the Hilton Syon Park in London for its third edition this 4-5 December. Bringing together 60 Legal Operations Leaders and General Counsels for two days of learning, discussion and networking, attendees will discover new solutions to their unique challenges and gain insight on effectively leveraging data and technology for efficiency gains and positioning the legal team at the heart of the organisation.

Given the progress in data analytics and generative AI solutions, the call to modernise and innovate in-house legal departments has never been more pressing. As the stewards of this shift to a more efficient and future-facing legal department, legal operations teams must both understand the legal technology landscape while also mastering the softer skills needed to implement and manage change successfully.
The Legal Operations Exchange has been designed to address the complexities of improving in-house legal operations from all angles. Confirmed attendees at this year’s event include Legal Operations Directors, General Counsels and Heads of Legal from top-tier organisations such as The Access Group, L’Oreal and Arla. All participants have been selected to attend this invitation-only gathering based on their active requirements to innovate their legal department’s operations.  
A hallmark of the Legal Operations Exchange is its one-to-one business meetings which allow decision-makers who have pre-identified their specific challenges and investment areas to meet with relevant solution providers. With analysis by the Legal Operations Exchange revealing risk management, contract review and analytics, and document automation and generation as the top investment priorities of attendees so far, these bespoke, pre-scheduled meetings provide a dedicated platform for solution providers to demonstrate their capabilities to those actively seeking new solutions.
With nearly 10 hours of time dedicated to organic networking and pre-scheduled business meetings over the course of the two days, the event provides the opportunity for end users and solution providers alike to form new and lasting relationships. One previous attendee from Red Bull commented that: “The Legal Operations Exchange event was an excellent opportunity for networking. Its size was perfect – not too large, so you didn’t feel lost in the crowd, and not too small, so there was a diverse group of professionals to connect with. I found it incredibly easy to engage in meaningful conversations and build connections.”
The Legal Operations Exchange’s world-class, cross-industry speaker faculty is comprised of leading figures in the legal operations world, including Silke Engel, Director of Legal, Legal Operations and Technology at Coca Cola Europacific Partners, and Niklas Rahlmeyer, Head of New Business, Legal Operations and Services at E.ON.
For Legal Operations professionals, General Counsels and solution providers, the Legal Operations Exchange provides an unparalleled opportunity to form meaningful connections and share best practices for enhancing legal operations in today’s complex landscape. To secure your place or for more information on sponsorship opportunities, contact the Legal Operations Exchange team at [email protected] or visit our website here.
Contact: Kazia [email protected] 

View original content:https://www.prnewswire.co.uk/news-releases/legal-operations-leaders-and-general-counsels-to-discuss-business-critical-challenges-at-legal-operations-exchange-2024-302262399.html

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Tyne and Wear Fire and Rescue Service U.K. to Deploy Motorola Solutions’ Cloud-Hosted Control Room Solution

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New response system helps streamlining workflows, strengthening resilience and improving safety for more than 1 million people in Northeast England
LONDON, Sept. 30, 2024 /PRNewswire/ — Tyne and Wear Fire and Rescue Service has announced that it is strengthening its emergency response capabilities through a cloud-hosted Control Room Solution (CRS) from Motorola Solutions (NYSE: MSI). This move will foster digitalisation, streamline workflows and offer the agency the ability to better scale operations in critical situations such as flooding and wildfires, which have increased in frequency in the U.K. in recent years.

“Our objective is to create one of the safest communities in the country,” said Phil Clark, Area Manager for mobilising and digital transformation at Tyne and Wear Fire and Rescue Service. “We are amongst the fastest responding fire and rescue services in the U.K. for dwelling fires with an average response time of 5 minutes 58 seconds.”
“We will continue to invest in new technologies and plan to offer other fire and rescue services the opportunity to join our newly created control room solution,” said Area Manager Clark. “In doing so, we’ll be able to seamlessly exchange information during joint operations, increase scalability to accommodate varying demand levels, and foster greater cooperation and faster responses in critical situations. Our relationship with Motorola Solutions will enable us to realise and deliver our operational vision, which will ultimately help to save lives and put Tyne and Wear Fire and Rescue Service at the forefront of Control Room technology in the U.K.”          
Every day, more than 1 million people rely on Tyne and Wear Fire and Rescue Service, who operate 17 community fire stations in Northeast England. Their responsibilities across the community include responding to primary and secondary fires, road traffic collisions, civil emergencies, water and structural rescues and delivering fire safety advice to residents and businesses.
The browser-based CRS enables staff to access the control room by securely logging on from any location to set up mobile command posts or provide remote support for incidents. The new platform will integrate Motorola Solutions’ CommandCentral Evidence software for storing and securely handling control room voice recordings, unifying critical communications and data in one platform, while also linking to the appropriate cases.
“Demand on the fire and rescue service has evolved over the years, and emergency services continue to respond to a wide range of complex incidents,” said Fergus Mayne, U.K. and Ireland country manager at Motorola Solutions. “Our cloud-hosted CRS solution benefits Tyne and Wear Fire and Rescue Service with an intuitive and unified response system that integrates all communications into one efficient and resilient work environment.”
About Motorola Solutions
Motorola Solutions is solving for safer. We build and connect technologies to help protect people, property and places. Our solutions enable the collaboration between public safety agencies and enterprises that’s critical for a proactive approach to safety and security. Learn more about how we’re solving for safer communities, safer schools, safer hospitals, safer businesses – safer everywhere – at www.motorolasolutions.com.
Tyne and Wear Fire and Rescue Service
Tyne and Wear Fire and Rescue Service leads the operational delivery of fire and rescue, including public protection, emergency prevention and resilience for the five local authority areas of Gateshead, Newcastle, North Tyneside, South Tyneside and Sunderland. 
The fire service operates from 17 community fire stations across Tyne and Wear, with our stations, employees and appliances strategically placed across the region to ensure efficient and effective response to fire and rescue emergencies. www.twfire.gov.uk 
Photo – https://mma.prnewswire.com/media/2517802/TWFRS_Control_Room.jpg
 

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Heimdal and emt Distribution Aim to Dominate the Middle East Cybersecurity Market

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COPENHAGEN, Denmark and DUBAI, UAE, Sept. 30, 2024 /PRNewswire/ — Heimdal and emt Distribution announce a strategic partnership that combines Heimdal’s advanced cybersecurity solutions with emt Distribution’s deep market expertise.

The collaboration will deliver sophisticated yet user friendly products to the Middle East. With Heimdal offering the widest cybersecurity stack in the world, and emt Distribution being the region’s leading distributor, the partnership is well-positioned for success.
Together, they are committed to educating the market on how strategic consolidation, training, and strong vendor relationships will maximize value.
Bringing a new dynamic to the market
Under this partnership, the two parties have promised to:
Roll out Heimdal’s Patch Management solution right away, as it’s a clear improvement over existing tools in the market.Provide local hosting in the United Arab Emirates by 2025, offering compliant, high-performance cloud services tailored to regional needs.Drive new technology adoption with pioneering tools, like the Threat Hunting and Action Center, along with emt Distribution’s market know-how.Offer easy-to-use technology, hands-on training, and show how a SOC can close security gaps while boosting profits.M Mobasseri, Co-Founder and CEO of emt Distribution META: “As we work closely with many cybersecurity experts and CISOs, we consistently encounter a range of challenges, particularly the complexity of managing numerous platforms. These platforms not only require specialized expertise but are also resource-intensive and costly.”
“Having known Heimdal for many years, I’ve witnessed their substantial investments in addressing these challenges and their development of a comprehensive cybersecurity platform that meets the critical needs of customers in the region.”
“Together with Heimdal, we are striving to integrate best-of-breed technologies into a unified platform, with plans for local hosting in 2025 to ensure compliance for businesses of all sizes. In addition, we are excited to announce special terms for our channel partners, aimed at maximizing their growth and profitability.”
Jesper Frederiksen, CEO of Heimdal, commented on the announcement: “Heimdal is pleased to announce a strategic partnership with emt Distribution, the leading security distributor in the Middle East. This collaboration comes in response to the rapidly growing demand for advanced cybersecurity solutions across the region.”
“By joining forces with emt Distribution, Heimdal aims to leverage their extensive network of resellers to provide cybersecurity solutions to organizations throughout the Middle East. Our joint initiative will focus on empowering organizations to significantly reduce their cyber risk exposure through Heimdal’s easy-to-use and cost-effective security solutions and emt Distribution’s unparalleled market reach.”, he added.
About emt Distribution META
emt Distribution META is a channel company with over 30 years of experience in security distribution, offering cyber threat mitigation solutions for Enterprises, SMBs, and MSPs. Committed to selling through channel partners, emt supports a large reseller base and provides technical support and professional services.
For more information, visit emt Distribution.
About Heimdal
Established in Copenhagen in 2014, Heimdal® empowers CISOs, security teams, and IT administrators to improve their security operations, reduce alert fatigue, and implement proactive measures through a unified command and control platform.
Heimdal’s award-winning cybersecurity solutions span the entire IT estate, addressing challenges from endpoint to network levels, including vulnerability management, privileged access, Zero Trust implementation, and ransomware prevention.
For more information, visit Heimdal.
For further press information:
Madalina PopoviciMedia Relations [email protected] 
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/heimdal-security/r/heimdal-and-emt-distribution-aim-to-dominate-the-middle-east-cybersecurity-market,c4044480
The following files are available for download:
https://mb.cision.com/Main/22623/4044480/3028629.pdf
Heimdal and emt Distribution Partnership – Press Release
https://news.cision.com/heimdal-security/i/heimdal-and-emt-distribution-partnership,c3338145
Heimdal and emt Distribution Partnership
 

View original content:https://www.prnewswire.co.uk/news-releases/heimdal-and-emt-distribution-aim-to-dominate-the-middle-east-cybersecurity-market-302262358.html

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