Avistone's ANS014004, a Novel c-Met Inhibitor, Advances in Phase I Trials for Solid Tumors

Key Insights

• Avistone Biotechnology's ANS014004, a type II c-Met inhibitor, has been cleared for Phase I trial enrollment in Canada, expanding its clinical evaluation.
• The Phase I trials in the US and China are enrolling patients with advanced solid tumors harboring MET alterations, including mutations and amplifications.
• The studies aim to assess the safety, tolerability, and optimal dosing of ANS014004, addressing the need for next-generation MET inhibitors.

Avistone Biotechnology is advancing its novel small-molecule type II c-Met tyrosine kinase inhibitor (TKI), ANS014004, in Phase I clinical trials, with recent clearance to proceed with patient enrollment in Canada by Health Canada. This follows the U.S. FDA's clearance of the Investigational New Drug (IND) Application last year, where the dose escalation portion of the Phase I study is currently enrolling patients.

Phase I Trial Details

The ongoing Phase I trials (NCT06307795 in the US and NCT06328439 in China) are enrolling patients with locally advanced or metastatic solid tumors harboring a pathogenic MET alteration, including MET mutations, MET amplifications, MET overexpression, or MET fusions. The primary objectives of these studies are to evaluate the tolerability and safety of ANS014004 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).

Addressing Unmet Needs in MET-Driven Cancers

The mesenchymal epithelial transition (MET) proto-oncogene receptor tyrosine kinase (RTK) is a cell surface receptor that, when aberrant, drives oncogenesis in a variety of human solid cancers. These alterations include MET exon 14 skipping (METΔex14) mutations, activating mutations in the kinase domain, MET gene amplification, MET fusions, and MET protein overexpression.

Currently, type I c-Met inhibitors are used as monotherapies in patients with locally advanced or metastatic NSCLC with METΔex14 mutations. However, resistance to these inhibitors can develop through acquired mutations in codons D1228 and Y1230. ANS014004, as a type II inhibitor, aims to address these resistance mechanisms and provide a treatment option for patients with various MET oncogenic alterations beyond METΔex14, including those with post-treatment acquired mutations.

Avistone's Focus on Precision Oncology

Avistone Biotechnology is focused on developing innovative therapies for patients with significant unmet medical needs globally. The company has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors. The advancement of ANS014004 represents a significant step in their commitment to precision oncology.