Yen Yun

Affiliations 

Professor, President, Taipei Medical University

Biography

Dr. Yen is currently a professor of Institute for Cancer Biology and Drug Discovery and the President of Taipei Medical University, Taiwan. He served as Associate Director for Translational Research at the City of Hope Comprehensive Cancer Center in Los Angeles, and co-leader of the Developmental Cancer Therapeutics Program as the Allen and Lee Chao Endowed Chair. He was also Chair of the Molecular Pharmacology Department, Interim Chair of medical oncology department, Professor of Medical Oncology in the Graduate School of Biological Sciences at City of Hope, and an affiliate professor of the bioengineering department of California Technology Institute.  

Abstract

Nanoparticle in Cancer Medicine 

Nanoparticle‐based experimental therapeutics are currently being investigated in numerous human clinical trials. CALAA‐01 is a targeted, polymer‐based nanoparticle containing small interfering RNA (siRNA) and, to our knowledge, was the first RNA interference (RNAi)‐based, experimental therapeutic to be administered to cancer patients. Here, we report the results from the initial phase I clinical trial treated with CALAA‐01 and compare those results to data obtained from multispecies animal studies to provide a detailed example of translating this class of nanoparticles from animals to humans.

The pharmacokinetics of CALAA‐01 in mice, rats, monkeys, and humans show fast elimination and reveal that the maximum concentration obtained in the blood after i.v. administration correlates with body weight across all species. The safety profile of CALAA‐01 in animals is similarly obtained in humans except that animal kidney toxicities are not observed in humans; this could be due to the use of a predosing hydration protocol used in the clinic. Taken in total, the animal models do appear to predict the behavior of CALAA‐01 in humans and CALAA-01 is well tolerant in human. The further study of CALAA-01 in Phase II is currently on going!