New Anticancer Drugs

Anticancer drug discovery is a critical effort to develop treatments for the rare and refractory disease of cancer. Advances in cancer therapy can save many lives. This section introduces several new anticancer drug development examples and explains the nonclinical studies used in each case.

Development Case Study: National Cancer Center (Japan)

The National Cancer Center is collaborating with Eisai to create therapeutic candidates for rare and refractory cancers. The project uses patient-derived xenograft (PDX) models—in which tumor tissue from patients is transplanted into immunodeficient mice—and cancer genome data to help accelerate the development of novel anticancer candidates. Through this approach, the Center has established an integrated bench-to-clinic drug-discovery workflow spanning nonclinical through clinical research.

Nonclinical Studies

At the National Cancer Center, nonclinical studies leverage a PDX model library together with cancer genome data. These studies aim to rapidly identify promising treatments and expedite transition to clinical evaluation. Specifically, the work seeks to predict therapeutic efficacy accurately and efficiently and to elucidate therapeutic effects, adverse effects, and mechanisms of resistance.

Development Case Study: Tokyo University of Pharmacy and Life Sciences

Professor Hayashi at Tokyo University of Pharmacy and Life Sciences developed the anticancer agent plinabulin, originating from a peptidomimetic scaffold. Plinabulin represents a novel approach that disrupts tumor vasculature (including existing vessels) and induces apoptosis in cancer cells, thereby depriving tumors of nutrients. Plinabulin is in the final stages of clinical trials in the United States and China, and approval is expected in the near future.

Nonclinical Studies

Professor Hayashi’s laboratory conducted nonclinical studies that included structural modification of plinabulin to enhance its drug efficacy, evaluation of direct antitumor activity, and verification of vascular-disrupting effects against neovasculature. Ongoing clinical programs at a U.S. pharmaceutical company are also investigating plinabulin in combination with a taxane.

Summary

The development of new anticancer agents is a critical initiative shaping the future of cancer therapy. The case studies from the National Cancer Center (Japan) and Tokyo University of Pharmacy and Life Sciences illustrate the central role of nonclinical studies and their specific methods. Data from nonclinical studies function as a vital bridge to clinical trials, supporting the development of more effective anticancer drugs and ultimately contributing to patient care.