Promoting Projects to Use Genetic Marker Screening

Tokyo- February 15, 2021 –CMIC Co., Ltd. (hereinafter “CMIC”) announced today that it has entered into a joint research agreement with the National Cancer Center Japan (hereinafter, “NCC”) on December 22, 2020, regarding the use of data on cancer-related gene mutations in hematopoietic neoplasms (i.e., blood cancer). The HM (Hematologic Malignancies)-SCREEN-Japan project*1, which is led by the NCC, and CMIC, which has extensive experience in clinical development in the field of oncology, including blood cancer, will collaborate to deliver new drugs to patients with blood cancer as soon as possible.

*1: A multicenter research project to profile cancer-related gene abnormalities in patients with blood cancer who are not suitable candidates for standard first-line treatment or who have relapsed/refractory blood cancer.

The development of therapies targeting specific gene mutations (e.g., molecular targeted drugs) is rapidly advancing in cancer drug therapy, but there are many rare types of blood cancer for which the clinical development of treatments has not yet started in Japan due to a small patient population.

CMIC aims to promote clinical development in this field in Japan by using cancer-related gene analysis data from this joint research project to promote implementation plans for physician-led clinical trials in collaboration with HM-SCREEN-Japan.


■ Main roles in the joint research



Research coordination

Protocol development, sample collection, interpretation of gene analysis results

Database construction, etc.

CMIC Activities to promote the utilization of gene databases, etc.

■ Planned research period: January 1, 2021 to December 31, 2022


“In the field of blood cancer, where many patients have relapsed/refractory disease, there is strong demand for the creation of new therapies. Moreover, in Japan, where the patient populations with each blood cancers are small, there is an ongoing need to accumulate patients through collaborative research networks in order to accelerate clinical development in this field. Through this joint research, we aim to provide new treatment opportunities for patients with blood cancer in Japan by proactively approaching pharmaceutical companies, biotechnology ventures, and academia in and outside Japan, as well as overseas pharmaceutical companies that have no previous experience in clinical development in Japan. CMIC will continue to commit to the promotion of new drug development in the field of blood cancer, where more specialized services are needed.” said Toru Fujieda, President of CMIC Co., Ltd.



■ About HM (Hematologic Malignancies)-SCREEN-Japan

HM (Hematologic Malignancies)-SCREEN-Japan (Principal Researcher: Dr. Yosuke Minami, Department of Hematology, National Cancer Center Hospital East) is a multicenter research project to profile cancer-related gene abnormalities in patients with blood cancer who are not suitable candidates for standard first-line treatment or who have relapsed/refractory blood cancer. The National Cancer Center Japan launched with the aim of accelerating the development of early-stage therapies and reverse translational research (reverse TR)*2 for hematopoietic neoplasms, such as refractory leukemia on February, 2019. As of January, 2021, 17 centers across Japan, including the National Cancer Center Hospital East, are participating in the project. HM-SCREEN-Japan will help stimulate new drug development trials in the field of leukemia in Japan, as well as to the discovery of resistance factors and the development of new drugs and biomarkers to overcome those factors, thereby raising the overall level of development research in the field of hematology.

*2: Reverse translational research is a process to link discoveries made in basic research to the diagnosis and treatment of diseases, and, in turn, provide feedback to basic researchers on problems and questions raised in clinical practice regarding the new diagnostic methods and drugs created.

■About CMIC group

CMIC Group was founded in 1992 as the first Contract Research Organization (CRO) in Japan. Today CMIC Group is the largest clinical CRO in Japan with global footprint, providing comprehensive services in drug development, clinical site management, manufacturing, regulatory consulting and contract sales & marketing solutions. We can help pharmaceutical, biotech and medical device companies to enter Japan market, to conduct clinical trials in Asia, or to bridge drug development and manufacturing needs in the US, Europe, Japan and broader Asia. CMIC Group has over 7,000 employees and 25 sites globally. For more information about CMIC Group and services, please visit our website.


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