Avistone raised $140m in Series B financing in January this year to support pipeline activities. Image credit: Shutterstock/Lightspring.

Beijing Avistone Biotechnology’s Phase I trial evaluating its candidate for mesenchymal epithelial transition (MET) alteration solid tumour treatment has been cleared for enrolment by Health Canada.

The first-in-human, open-label, multi-centre study was authorised by the US Food and Drug Administration (FDA) in 2023 and is currently enrolling US patients in a dose escalation portion.

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Avistone has not disclosed the sites in Canada that will be involved in the study. There are five US locations as per the trial’s ClinicalTrials.gov entry, with only the Sarah Cannon Research Institute in Colorado enrollingat present. The China-headquartered biotech aims to enrol 63 cancer patients in the study.

Avistone’s candidate, named ANS014004, is a small-molecule type II c-Met tyrosine kinase inhibitor (TKI). The company is targeting locally advanced or metastatic solid tumours harbouring a pathogenetic MET alteration. This includes MET mutation, MET amplification, MET overexpression, or MET fusion.

Whilst there are currently MET inhibitors used as monotherapies in patients with lung cancer, Avistone says that the development of post-treatment resistance to type I c-Met inhibitors occurs clinically.

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Avistone’s primary endpoints in its trial are to evaluate the tolerability and safety of ANS014004 and to determine the maximum tolerated dose (MTD) of ANS014004, as well as or instead of a recommended Phase 2 dose (RP2D) of ANS014004.

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MET mutations occur in a variety of solid tumours. The hepatocyte growth factor (HGF) can activate the c-mesenchymal-epithelial transition factor (c-Met), a receptor tyrosine kinase which switches on several signalling pathways involved in cell and tumour proliferation. This signalling pathway is dysregulated in several cancer types with MET mutations.

Avistone is also conducting a simultaneous Phase I study with ANS014004 in China, estimated to enrol 216 patients with locally advanced or metastatic solid tumours.

The biotech raised $140m in Series B financing in January this year to support development of its pipeline and commercialisation efforts of its lead asset PLB1001 (vebreltinib) in China.