Eisai Co., Ltd. and the National Cancer Center Japan announced today that both parties have entered into a joint research and development (R&D) agreement concerning “Basic research on the drug discovery and development to accelerate development of anticancer drugs in treatment of patients with rare cancers and refractory cancers”, and that research activities have commenced. This R&D project is to be carried out with funding under the program “Cyclic Innovation for Clinical Empowerment (CiCLE)” established by the Japan Agency for Medical Research and Development (AMED).
Rare cancer is a disease for which it is difficult for pharmaceutical companies to develop new drugs solo due to the extremely small number of patients, and there are only a limited number of drugs for rare cancers that can be approved for manufacturing and marketing. Also, among certain types of cancer with a large number of patients, refractory cancers, for which standard treatment has not been established, face barriers to creating new drugs due to difficulty of research and development. In order to promptly deliver effective treatments to patients with rare or refractory cancers, it is essential to provide predictability of clinical outcomes with high accuracy and efficiency in non-clinical research that confirms in advance the effectiveness of the drug, to transfer seamlessly non-clinical research to clinical studies, and moreover to elucidate the mechanism of drug resistance, actual therapeutic effects and side effects. Both parties aim to realize these capabilities in this R&D project using Patient-Derived Xenografts (PDX) library, a model in which cancer tissue derived from patients is transplanted into immunodeficient mice with high predictability of clinical outcomes, as well as cancer genome data.
Eisai is advancing the research and development of new anticancer drugs, targeting cancer genomics and the tumor microenvironment, with its experience and knowledge from globally approved in-house discovered compounds: microtubule dynamics inhibitor eribulin mesylate (product name: Halaven) and multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product names: Lenvima).
The National Cancer Center is a leading institution in basic research, epidemiological research, and clinical studies for all cancer types including rare cancers in Japan. As of May 2020, with a grant from AMED CiCLE, the National Cancer Center has established a large-scale PDX library,”J-PDX”, derived from Japanese cancer patients with information on clinical outcomes, and has also completed the development of research infrastructure and framework. More than 410 types of PDX, including rare cancers and refractory cancers, have already been established in J-PDX (as of March 2021).
In research and development under the agreement, Eisai and the National Cancer Center will jointly conduct tumor-agnostic non-clinical research on new drug candidates created by Eisai, using J-PDX with relevant clinical and biological information, and will determine the drugs and the target cancer types to be transferred to clinical studies. After that, investigator-initiated studies will be conducted for rare cancers and refractory cancers in order to confirm clinical benefits of these new drugs, with the aim to apply for approval of them. Further, both parties will consider expanding into new drug discovery research, with establishment of PDX with tumor tissues taken from patients before and after treatment, comparative analyses of drug responsiveness and cancer genome, as well as search for new drug discovery targets and elucidation of drug resistance mechanisms. Through these efforts, both parties aim to establish a drug discovery and development research system that accelerates the development of new anticancer drugs in Japan.
Through research and development based on the agreement, Eisai and the National Cancer Center will work to develop therapeutic drugs for rare cancers and refractory cancers with high unmet medical needs, thereby aiming to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.
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