Arbele, a clinical stage biopharmaceutical company, announces the successful dosing of the first patient in Australia in Phase I Study of ARB202, for the treatment of advanced gastrointestinal cancers patients. Globally, Arbele is the first company exploring the potential of CDH17xCD3 bispecific T-Cell engager antibody in cancer immunotherapy.
“Dosing patients is a significant first step in targeting cadherin-17 on gastrointestinal cancers which globally affects so many lives, particularly in East Asia” said Dr. Dennis Wong, MD, Chief Medical Officer of Arbele.
The Phase I trial is a continuous multi-center, open-label, dose-escalation trial for both the ascending dose (Phase Ia) and dose ranging (Phase Ib/2a) phases (clinicaltrials.gov: NCT05411133), with aims to determine the tolerability and/or to be used dose of ARB202. The preliminary effects on biomarkers and clinical efficacy of ARB202 in GI cancer patients will be examined. Given tolerability potential expansion cohorts will further evaluate the safety and efficacy of ARB202 in specific indication(s) and in combination with other therapy. Arbele expects to report initial safety, tolerability, and PK/PD data in 2Q 2023.
ARB202 is a first-in-class bispecific antibody based on Abele’s patented CDH17 biomarker. The unique differential binding affinities of ARB202 toward CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the “off-target” overactivation of T cells. Preclinical data showed that ARB202 can effectively increase interactions between T cells and target cancer cells that expresses CDH17. The trial is being led by Professor Paul de Souza of Western Sydney University Medical School and conjoint Professor, UNSW in Sydney, and Prof. Roland Leung of University of Hong Kong at Queen Mary Hospital. We also plan to expand the studies in the US and China, Japan, and Singapore.
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