Avistone Announces Updates on ANS014004

BEIJING

Beijing Avistone Biotechnology Co., Ltd (also referred to as “Avistone Biotechnology” or “Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the Phase I dose escalation study evaluating ANS014004 (“ANS01”), a novel small-molecule type II c-Met tyrosine kinase inhibitor (TKI) was recently cleared to proceed with enrollment of patients in Canada by Health Canada. The U.S. Food and Drug Administration (FDA) cleared ANS01’s Investigational New Drug (IND) Application last year and the trial is currently enrolling US patients in the dose escalation portion of the phase 1 study. Detailed information on the trial can be found at https://clinicaltrials.gov/study/NCT06307795.

There is also a concurrent, ongoing Phase I study operating in China and detailed information on this study can be found at: https://clinicaltrials.gov/study/NCT06328439.

Both Phase I studies are enrolling patients diagnosed with locally advanced or metastatic solid tumors harboring a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, or MET fusion) and the primary objectives are (1) to evaluate the tolerability and safety of ANS014004 and (2) to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ANS014004.

Mesenchymal epithelial transition (MET) proto-oncogene receptor tyrosine kinase (RTK) is a cell surface receptor selective for hepatocyte growth factor (HGF), and is involved in embryogenesis regulation, wound healing, organ regeneration, angiogenesis, and immunomodulation. Aberrant MET oncogenic alterations include MET exon 14 skipping (MET∆ex14) mutations; activating mutations in the kinase domain; MET gene amplification; MET fusions; and MET protein overexpression. These oncogenic alterations occur in a wide range of human solid cancers.

Presently, type I c-Met inhibitors are used as monotherapies in patients with locally advanced or metastatic NSCLC with MET∆ex14 mutations. However, development of post-treatment resistance to type I c-Met inhibitors occurs clinically, including through acquired mutations in codons D1228 and Y1230. No drugs have been approved globally for MET alteration indications other than MET∆ex14 mutations. Next generation MET inhibitors are thus needed to treat patients harboring various MET oncogenic alterations beyond MET∆ex14, including post-treatment acquired mutations.

About Avistone Biotechnology
Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors.

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