Immunotherapy and cell therapy for cancer / 中国药理学与毒理学杂志

Cancer immunotherapies are recently gaining attention as viable therapeutic options. There are two types of immunotherapy:passive and active. The passive immunotherapies include several treatments such as monoclonal antibodies,either alone or as antibody-drug conjugates. The active immunotherapies include cancer vaccines which utilize the patient′s own cells as antigen presenting cells and target specific cancer antigens,and chimeric antigen receptor T-cell(CAR-T)therapy which engineers a patient′s T-cells to recognize cancer antigens through chimeric antigen receptors. Recent successes include the US FDA approval of a number of cancer immunotherapies such as treatments utilizing monoclonal antibodies against immune checkpoint inhibitors,the Provenge cancer vaccine that targets prostrate cancer,and a CAR-T against relapsed/refractory acute lymphoblastic leukemia that was designated with breakthrough drug status,all of which has had drug companies investigating cancer immunotherapies with intense enthusiasm. In this review we discuss where the field of immune-oncology stands today,highlight the latest findings and hypothesize future directions.

Current trends of nonclinical safety evaluation for new drugs / 中国药理学与毒理学杂志

Nonclinical safety evaluation plays a critical role in the process of new drug development.International Conference on Harmonization (ICH) guideline M3 (R2) provides a key direction for the nonclinical safety evaluation process.Proper strategies and toxicological studies should be considered together to move the drug candidates forward efficiently and quickly to support clinical plans and market registration.Updates on ICH guidelines,such as ICH S6 and ICH S9,have great impact on the direction of development.With the increasing cost of development and competition in the industry,elements like predictivity,animal models,and regulatory compliance are also very important in the process.Therefore,an insight into all these factors is essential to toxicologists in the safety evaluation process.The ability to use the overall knowledge will result in a quicker and better new drug development program.