AnBogen Therapeutics Receives Approval from U.S. FDA for Phase Ib/II Protocol Amendment for ABT-101

September, 2022

An oral Tyrosine Kinase Inhibitor of HER2 Exon20 Insertion, for the Treatment of Non-Small Cell Lung Cancer

TAIPEI, Sept. 13, 2022 /PRNewswire/ -- AnBogen Therapeutics, a clinical-stage biotech company designing and developing precision oncology therapies to improve the life of patients, announces today that U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) protocol amendment for its phase Ib/II trial of ABT-101, an orally administered, irreversible, mutant selective tyrosine kinase inhibitor targeting oncogenic mutations of HER2 Exon20 insertion expressed in non-small cell lung cancer (NSCLC). "We are pleased to receive approval from the FDA on the protocol amendment, and continue to drive ABT-101 clinical development program forward. With the mission in mind, we want to make impact to transform the treatment for patients with non-small cell lung cancer harboring exon 20 insertions (e20i) in HER2," said John Tsu-An Hsu, Ph.D, Founder and Chief Executive Officer of Anbogen Therapeutics. "We look forward to working closely with FDA and all of our investigators as we enroll and dose the patients with non-small cell lung cancer (NSCLC). ABT-101 demonstrates excellent therapeutic potential and superior safety profile compared to competitors that are under clinical development, and it meets challenges of unmet medical needs for cancer drugs targeting exon 20 insertions (e20i) in HER2."


ABT-101 is a potent small molecule kinase inhibitor against several oncogenic kinases including epidermal growth factor receptor (EGFR), and human epidermal growth factor receptor 2 (HER2, also known as ERBB2). Approximately 10% to 12% of EGFR mutations and about 2% to 4 % of HER2 mutations in NSCLC are present in exon 20. Importantly, 90% of HER2 mutations in NSCLC are exon 20 mutations. It is estimated that the global annual patient population is greater than 56,000 who harbor HER2 exon insertion mutation. In the pre-clinical pharmacological studies, Anbogen has demonstrated that ABT-101 has superior selectivity against HER2 e20i mutation and significantly inhibits the growth of tumor harboring HER2-e20i.

About Anbogen Therapeutics

Anbogen Therapeutics is a clinical-stage biotech company designing and developing precision oncology therapies to improve the life of patients. Founded by a group of exceptional scientists from National Health Research Institute, the most prestigious medical research institute in Taiwan, Anbogen Therapeutics is devoted to bringing gap between research and clinical development, and dedicated to creating breakthrough science that meaningfully changes life of patients. With the vision to deliver the best-in-class treatments, our collective experience in medicinal chemistry, cancer biology, drug discovery and clinical development, which greatly enable the development of differentiated pipeline in the field of precision oncology.