SYDNEY, Aug. 2, 2023 /PRNewswire/ — Arbele, a clinical-stage biotechnology company developing novel immunotherapies targeted for advanced gastrointestinal cancers, presented early safety data from its first-in-class CDH17xCD3 bispecific T-cell engager antibody, ARB202, at the ASCO Breakthrough conference in Yokohama, Japan.
Preliminary data from Phase 1a study indicate ARB202 tolerability up to 150ng/ml Cmax in circulation, suggesting no clinically significant off-target T-cell activation at these levels. A total of ten (10) [6 colorectal carcinoma; 2 cholangiocarcinoma; 1 gastric cancer; 1 gastrointestinal adenocarcinoma] have completed dosing across the first 3 dose-level cohorts ranging from 0.0003 to 0.003 mg/kg by single IV doses. The Cmax measured within 1 hour of dosing confirms the circulating PK range of 10-20 ng/ml for the 2nd cohort and 40-50 ng/ml in the 3rd cohort, which are consistent with the expected PK. As of 29 Jun 2023, the safety review committee and an independent data monitoring committee, DMC, had approved the trial to continue without modification.
These data allow for continued dose escalation with the aim of identifying the optimal dose where ARB202 mediates CDH17-specific immunological synapse formation between target cancer cells and T-cells in solid tumors with minimal on-target effects on normal cells. As these data mature, Arbele intends to present more findings at an appropriate scientific meeting.
“We are excited by the current safety profile of ARB202 and indications of clinical activity. They are consistent with us entering the therapeutic window which is competitive and perhaps even more specific than other T-cell engagers directed at solid tumors.” said Dr Dennis Wong, Chief Medical Officer at Arbele.
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 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 facilitate T-cell activation and release of IL-2, thereby demonstrating target engagement and cytotoxicity. The Phase 1 trial is currently enrolling patients in Australia and Hong Kong (NCT05411133).
Arbele is founded in 2016 by former senior executives from multinational pharmaceutical companies, with R&D presence in Hong Kong, Sydney, Seattle, Guangzhou and Singapore. It focuses on the development of breakthrough diagnostic platforms and innovative immunotherapy; to provide early intervention and treatment for people with gastrointestinal cancers including but not limited to colorectal cancer, pancreatic cancer, gastric cancer, gastroesophageal junction cancer, liver cancer and cholangiocarcinoma, for which effective treatment options are scanty with high mortality rates. For more information on ARBELE, please visit http://www.arbelebio.com/
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