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First in the World! Arbele’s CDH17xCD3 Bispecific Antibody Received Clinical Trial Phase I Ethics Approval in Australia

On March 31, 2022, the clinical trial application of ARB202 received ethics approval in Australia. ARB202 is an innovative bispecific antibody drug developed by AIM-HI Portfolio Company Arbele, a biotech company based in the Hong Kong Science and Technology Park. ARB202 is used to treat late-stage gastrointestinal (GI) cancer and is the world’s first CDH17xCD3 bispecific antibody that has received clinical trial ethics approval.

About ARB202

 ARB202 is a first-in-class bispecific antibody based on Arbele’s patented CDH17 biomarker. It targets both CDH17 on GI cancer as well as CD3 on T cells. The unique differential binding affinities of ARB202 towards CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the “off-target” overactivation of T cells. This minimizes the risk of systemic inflammation.

Preclinical data showed that ARB202 can effectively increase interactions between T cells and GI cancer that expresses CDH17. This facilitates T cell activation, and the release of IL- 2, which are crucial for cytotoxicity. Injection of low-dose ARB202 antibodies can therefore suppress tumor growth effectively.

ARB202 has received ethics approval in Australia for a Phase I clinical trial, as a drug indicated for the potential treatment of late-stage GI cancer. Enrollment to the trial has begun, currently being conducted at the St. George Private Hospital (Ramsay Healthcare System). The trial is being led by Professor Paul de Souza, Professor at Western Sydney University Medical School, and conjoint Professor, UNSW. Pending ethics approval from the

Queen Mary Hospital, patient enrollment would begin in the third quarter of 2022 in Hong Kong. In addition, the company aims to submit IND filing for clinical trial applications to the China NMPA and the US FDA later this year.

“We are excited to bring ARB202, bispecific CDH17-T-cell engager, to address the huge therapeutic needs in gastrointestinal cancers”, said Dr. Dennis Wong, Chief Medical Officer of Arbele.


ARBELE is a biotech company founded in 2016 by former senior executives from Johnson & Johnson, Roche, Sanofi, and Bristol-Myers Squibb. Its team involves experienced scientists from top tier universities such as Cambridge, Oxford, Singapore, Stockholm and Hong Kong. ARBELE is based in Hong Kong, with subsidiaries in Guangzhou, Seattle, and Sydney. It focuses on the development of break-through diagnostic platforms and innovative immunotherapy; to provide early intervention and treatment for people with GI cancers including but not limited to gastric cancer, pancreatic cancer, colon cancer, bile duct cancer and liver cancer, for which effective treatment options are very limited with high mortality rates. For more information on ARBELE, please visit

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