Adagene declares FDA clearance to proceed with Phase 1b/2 clinical trial

KUALA LUMPUR, March 17 — Adagene Inc (Adagene) has announced FDA clearance to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with the anti-PD-1 antibody pembrolizumab.

According to a statement, the global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumours at multiple sites in the U.S. and Asia Pacific (APAC).

ADG126 SAFEbody is designed for conditional activation in the tumour microenvironment (TME), as well as to enhance the efficacy profile by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.

“The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 programme,” said Co-founder, Chief Executive Officer and Chairman of Adagene, Peter Luo, Ph.D.

“It builds on a strong safety profile for ADG126 SAFEbody and its parental antibody ADG116, respectively, as a single agent and the ability to achieve doses that may unlock the full potential of CTLA-4 as a proven target for strong ADCC-mediated Treg depletion in the TME.

“We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations. This multi-regional trial of ADG126 with pembrolizumab also reflects our commitment to bringing highly differentiated therapies to cancer patients globally.”

SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy.

Through activation in the TME, this allows for tumour-specific targeting of antibodies, while minimising on-target off-tumour toxicity in healthy tissues.

The ADG126-P001 trial is expected to dose the first patients soon. The trial is designed to evaluate safety and tolerability, and determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab.

Adagene Inc is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies.

More details at https://investor.adagene.com.

— BERNAMA

Technology leaders unveil SustainableIT.org to address climate change

KUALA LUMPUR, March 9 — A think-tank of global technology leaders and Delphix, the industry leader for DevOps test data management, have announced the formation of SustainableIT.org, a non-profit organisation focused on advancing global sustainability through technology leadership.

“For too long, sustainability has been a problem for someone else to solve. Today, we’re joining forces with technology leaders from the world’s largest organisations to make sustainability our collective problem to solve,” said Founding Director of SustainableIT.org and Delphix Founder and Chief Executive Officer (CEO), Jedidiah Yueh.

SustainableIT.org will unite IT leaders and experts from around the world to define best practices and standard metrics for all three pillars of sustainability in order to drive transparency and progress toward a sustainable future.

According to a statement, SustainableIT.org is a non profit governed by global technology leaders with the support of partners and the technical advisor, Delphix.

The founding board of directors includes Yueh; Amir Desai, CIO, Molina Healthcare; Chris Gates, CTO, Allstate; Bernard Gavgani, Global CIO, BNP Paribas; Josh Harbert, CMO, Delphix, President of SustainableIT.org; Brian Kirkland, CIO, Choice Hotels International; and Ralph Loura, CIO and CTO, Lumentum.

Also includes Bryan Muehlberger, CIO, The Beachbody Company; Vipul Nagrath, Senior Vice President, ADP; Neal Ramasamy, Global CIO, Cognizant; Andy Santacroce, Vice President and Deputy CIO, Tokio Marine North America; Mihir Shah, Enterprise Head of Data, Fidelity Investments; Suda Suvarna, Global Chief Solutions Officer, Deloitte; and, Katherine Wetmur, CTO, Morgan Stanley.

As part of its mandate, SustainableIT.org will define sustainable transformation programmes by industry, author best practices and frameworks, set standards and certifications, provide education and training, and raise awareness for environmental and societal programmes that make our organisations and the world sustainable for generations to come.

More details at http://www.delphix.com.

— BERNAMA

New NEP Middle East office to serve growing live broadcast needs

KUALA LUMPUR, March 7 — NEP Group, the leading media technology partner for content creators around the globe, has announced opening a new office in the United Arab Emirates (UAE) to meet the growing demand for its services, strengthening the company’s investment and presence in the Middle East.

Located across from the famed Khalifa Park in Abu Dhabi, NEP Middle East FZ LLC (NEP Middle East) will provide a wide range of outside broadcast solutions, including both on-site and remote production services, to enable clients to bring live sports and entertainment to fans and audiences around the region and worldwide.

NEP is expanding on its already extensive experience and work, ranging from covering UAE National Day celebrations and New Year’s Eve concerts, to many sporting events including Indian Premier League (IPL) 2021 and 2022, the International Cricket Council (ICC) Men’s T20 World Cup and T10 Cricket, and Ultimate Fighting Championship (UFC) Fight Island.

In addition, NEP’s Creative Technology business provides a full set of live event audio visual solutions to clients throughout the MENA region.

According to a statement, Saeed Izadi, current head of NEP’s Singapore and India businesses, has been appointed President of NEP Middle East, overseeing business strategy and operations for all three business units.

NEP also announced that Ammar Hina has joined the company as Business Development Director for the MENA region.

Hina brings more than 16 years of industry experience to lead business development and operations NEP Middle East, serving as the key contact for clients, major events and cross-divisional initiatives.

“I couldn’t be happier to welcome Ammar to NEP to spearhead our efforts for this very important market,” said Izadi.

“His expertise is enabling us to build a strong team locally while delivering superior service and innovative solutions for our clients located in the Middle East as well as international clients looking to share the events taking place in this great region with the rest of the world.”

Headquartered in the United States, NEP has operations in 25 countries with over 4,000+ employees.

— BERNAMA

UNVEILED: 2022 CHINA INTERNATIONAL CONSUMER PRODUCTS EXPO MASCOTS

KUALA LUMPUR, March 2 (Bernama) — Authorities in South China’s Hainan Province recently revealed the mascots for the 2022 China International Consumer Products Expo, styled after the Hainan gibbon.

Hainan gibbons are the most endangered of all gibbons and the world’s rarest primate. They are endemic to the southern Chinese island of Hainan.

The mascots reflect the green consumption approach of the expo, according to Ruslan Tulenov, a global media officer at the Hainan Provincial Bureau of International Economic Development.

The mascots embody the three dominant and distinctive industries of Hainan, namely the seed industry, deep-sea industry and aerospace industry, according to a statement.

Designers have endowed the mascots with diverse personalities, expecting that global enterprises and consumers can share opportunities and create a better life together through the expo, said Tulenov.

Themed ‘Share open opportunities, co-create a better life’, the event is scheduled to run from April 12 to 16 in Haikou, the capital of Hainan. This year, France will be the guest-of-honour country.

The exhibition area will span over 100,000 square metres, 80 per cent of which will be set up for overseas exhibitors featuring fashion, jewellery, food, medicine and other professional services.

The expo is expected to become a leading platform for global consumer fashion, and well-known brands will release their latest products during the exhibition.

— BERNAMA

GEORGE CLINICAL LATIN AMERICA RENAL SCIENTIFIC LEADERSHIP EXPANDS WITH HERNÁN TRIMARCHI

KUALA LUMPUR, March 2 (Bernama) — George Clinical has announced the expansion of its renal scientific leadership into Latin America with the addition of subject matter expert Hernán Trimarchi, MD, PHD, FACP, FASN.

His research focuses on glomerular diseases, particularly proteinuria and podocyturia, IgA nephropathy, focal segmental glomerulosclerosis, and Fabry disease.

Dr Trimarchi, who is Head of the Division of Nephrology and Renal Transplantation at the Hospital Británico de Buenos Aires and a member of the steering committee of the International IgA Nephropathy Network, is involved in many clinical research studies related to glomerular diseases and chronic kidney diseases as member of the advisory board and steering committee, as key opinion leader (KOL) or national coordinator.

“We are very pleased to have Hernán join a global scientific leadership team so rich in kidney research expertise,” said Chief Medical Officer Dr Maria Ali in a statement.

“He joins an organisation with deep roots in Asia-Pacific and his presence in Latin America rounds out the expertise of our team demonstrating the global relationships of our scientific leaders and highlighting how we work with regional experts to ensure clinical trials are designed pragmatically.”

In addition to his scientific leadership duties for George Clinical, Dr Trimarchi is Professor of Medicine of the Universidad Católica Argentina and former Director of the Post Graduate Course of Internal Medicine of the Universidad de Buenos Aires School of Medicine at the Hospital Británico.

He is a member of the ISN Continuing Medical Education Program Committee and an active member of the International Society of Nephrology and of the International Society of Transplantation.

“Joining the scientific leadership of George Clinical offers me the chance to engage with a variety of renal studies that could deliver tangible value for those suffering from kidney disease not just in South America but worldwide,” said Dr Trimarchi.

With more than 20 years of experience and 400 people managing 38 geographical locations throughout the USA, Asia-Pacific region, and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trials.

— BERNAMA