Takeda Pharmaceutical and M2Gen, a healthcare informatics solutions company, have established a new collaboration to generate broad genomic data from consenting cancer patients. Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) Avatar Research Program based on the Total Cancer Care Protocol, a prospective observational study enrolling patients with various cancers, and access information generated under this program.

Understanding and mapping the genetic profiles of patients with various types of cancer has the potential to speed new treatment discovery and development for millions of cancer patients worldwide. The data provided through M2Gen's ORIEN Avatar Research Program has the potential to enable ORIEN cancer centers to more rapidly find and enroll patients with specific biomarkers into Takeda clinical studies, among others. In addition, the genomic data will accompany clinical information such as stage of disease, demographics and treatment history, further enhancing translational medicine efforts. This collaborative approach, which brings together leading pharmaceutical companies, cancer research centers and patients, may allow for more effective and efficient development of treatments across many different cancers.

"One of the biggest challenges in oncology research is identifying the right cohort of patients for enrollment into clinical trials," said Phil Rowlands, interim head, Oncology Therapeutic Area Unit, Takeda. "Our innovative partnership with M2Gen has the potential to enable us to more quickly and precisely enroll patients at sites with a strong commitment to high quality translational medicine."

Through the agreement, Takeda will have access to patient de-identified information generated through the ORIEN Avatar Program, representing ORIEN's growing network of participating cancer centers. These 12 institutions, all leaders in cancer care, treat diverse populations of patients, who can elect to join the Total Cancer Care Protocol to potentially gain access to groundbreaking therapies and clinical trials. Patients who consent to participate in the protocol agree to be followed throughout their lifetime. ORIEN Avatar is focused on the use of rich clinical and molecular data to anticipate patient need, especially for novel cancer treatments through clinical trials open at ORIEN institutions.

"Our health informatics solutions allow us to share clinically meaningful data across the entire cancer care and research community—from patients to healthcare providers to the companies developing novel medicines," said William S. Dalton, Ph.D., M.D., founder and CEO, M2Gen.

"We are excited to welcome Takeda as one of the founding partners for our ORIEN Avatar program and look forward to working together to open new doors in oncology research," said Michael A. Caligiuri, M.D., director, The Ohio State University Comprehensive Cancer Center and CEO, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

This agreement is partially developed on the experience of Takeda and M2Gen, which previously partnered in 2014 to identify patients for several phase II studies in gastric and pancreatic cancer. This pilot program demonstrated M2Gen's capability to identify patients who might benefit from enrollment in the clinical trials and to facilitate rapid trial enrollment. Through ongoing collaborative learning, Takeda and M2Gen see the continued potential for success in scientific and clinical trial development and in meeting patient needs.