ANS-03 / Avistone Biotech - LARVOL DELTA

ANS03, a novel, orally bioavailable small-molecule type II ROS1/NTRK inhibitor, effectively overcomes clinically relevant ROS1/NTRK resistance mutations and exhibits potent antitumor activity in preclinical tumor models (AACR 2025) - "ANS03 also had better activity against the ROS1 L2086F mutation when compared to both Repotrectinib and NVL-520. Non-clinical studies of ANS03 showed it is a potent, orally bioavailable Type II ROS1/NTRK inhibitor with remarkable activity against various pathogenetic ROS1/NTRK alterations and with favorable absorption, distribution, pharmacokinetics, efficacy, and tolerability profiles in vivo. The compound will enter Phase 1 clinical development in the US and China soon."

Preclinical • Oncology • NTRK • NTRK1

Avistone Announces Preclinical Results for ANS03, a Novel Type II ROS1/NTRK Inhibitor in Overcoming Clinically Relevant ROS1/NTRK Resistance Mutations at AACR Annual Meeting 2025 (Businesswire) - "Beijing Avistone Biotechnology Co., Ltd...today announced that the preclinical data for ANS03, its novel, orally bioavailable Type II ROS1/NTRK tyrosine kinase inhibitor (TKI), will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025....Non-clinical studies of ANS03 showed it was a potent, orally bioavailable Type II ROS1/NTRK inhibitor with remarkable activity against various pathogenetic ROS1/NTRK alterations (including ROS1: G2032R, D2033N, L2086F; NTRK: G667C, G595R-G667C) and with favorable absorption, distribution, pharmacokinetics, efficacy, and tolerability profiles."

Preclinical • Solid Tumor

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Avistone Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Avistone Announces Updates on ANS03 (Businesswire) - "Beijing Avistone Biotechnology Co., Ltd...announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ANS03, a next generation tyrosine kinase inhibitor (TKI) targeting both ROS proto-oncogene 1 (ROS1) and neurotrophic tropomyosin receptor kinase (NTRK)....Enrollment of patients with locally advanced or metastatic tumors harboring a ROS1 or NTRK alteration is expected to begin in Q1 2025."

IND • New trial • Oncology • Solid Tumor