The University of Texas MD Anderson Cancer Center and TOPPAN Holdings have formed a strategic alliance to advance the development of TOPPAN's invivoid™ 3D cell culture technology as a clinical tool for personalized cancer treatments and drug screening. The collaboration combines TOPPAN Holdings' innovative organoid culture technology with MD Anderson's clinical and research expertise to accelerate the development of new clinical tools that could better inform physicians about expected therapy outcomes.
Regulatory Pathway and Clinical Validation
Under the agreement, researchers from both organizations will work collaboratively toward obtaining College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) certification of an organoid-based assay. This assay would evaluate the effectiveness of various cancer therapies on patient-derived samples and will be validated across several cancer types through clinical studies.
"Organoids allow us to model the three-dimensional complexity of human cancers in the lab, thus allowing us to engineer a powerful translational engine – one that could not only predict how patients will respond to therapy before treatment begins but also could help to reimagine how we discover and validate next-generation therapies," said Donna Hansel, M.D., Ph.D., division head of Pathology and Laboratory Medicine at MD Anderson.
Technology Platform and Clinical Applications
TOPPAN Holdings' proprietary 3D cell culture technology can rapidly establish organoid models directly from patient biopsies or other tissues. If validated clinically, researchers may be able to test a variety of potential treatments in the laboratory to understand which approach may work best for individual patients. This capability could help improve treatment outcomes while avoiding unnecessary treatments that may not be effective.
"The strategic alliance with MD Anderson paves a promising path toward personalized cancer medicine," said Hiroshi Asada, head of the Business Innovation Center at TOPPAN Holdings. "We believe our proprietary invivoid™ 3D cell culture technology, by enabling the rapid establishment of organoid models directly from patient biopsies, has strong potential to help identify more effective treatment options and reduce the likelihood of unnecessary therapies."
Development Timeline and Funding
The initial work will build upon preclinical research previously conducted under a collaboration between TOPPAN Holdings and MD Anderson researchers. Upon obtaining CAP/CLIA certification, observational clinical studies will be designed to evaluate how the organoid assay aligns with clinical outcomes. With initial success in those efforts, the research teams may progress toward prospective clinical studies, where the assay could be used to guide treatment approaches.
TOPPAN Holdings will provide approximately $10 million over five years to advance joint research activities and support efforts to obtain CAP/CLIA certification. Through collaboration on regulatory certification and clinical validation, the partners aim to bring this innovation closer to real-world patient care and contribute to the advancement of cancer medicine.
