UMN Research Leads to First-In-Human Clinical Trial for Bioengineered Anti-Cancer Drug

Manufacturing drugs isn’t commonly practiced in academic settings due to the extensive resources involved and requirement for knowledge of FDA compliance policies and procedures. However, the infrastructure and expertise at the University of Minnesota, including Phase I clinical trial specialists, the Masonic Cancer Center, the Clinical Trials Office, the Translational Therapy Lab, the School of Nursing, the Office of Technology Commercialization and the Investigational Drug Pharmacy, allowed U of M Medical School researchers to bioengineer the University’s own anti-cancer drug, now beginning a first-in-human clinical trial for leukemia.

Daniel Vallera, PhD, professor of Therapeutic Radiology-Radiation Oncology, played a major role in manufacturing this anti-cancer drug. Vallera’s research efforts in collaboration with the laboratories of Jeffrey Miller, MD, and Martin Felices, PhD, from the Medical School’s Department of Medicine led to the team’s discovery of exciting new inventions, including the new Natural killer (NK) cell engagers drug, known as TriKE: the bioengineered anti-cancer immunotherapeutic drug

This new drug prompted the first-in-human clinical trial and Phase I study to treat leukemia. The study will open exclusively at the University of Minnesota Medical Center, sponsored by GT Biopharma, Inc. and led by Principal Investigator Erica Warlick, MD, associate professor in the Division of Hematology, Oncology and Transplantation at the Medical School. Dr. Warlick is also a researcher at the Masonic Cancer Center.

“The Department of Radiation Oncology, chaired by Kathryn Dusenbery, MD, whole-heartedly supported my desire to establish a manufacturing facility for this cause, along with support from our Masonic Cancer Center director, Douglas Yee, MD, ” Vallera said. “I established a facility for manufacturing biologic drugs and melded it with the Molecular Cellular Therapeutics (MCT) facility’s quality programs, which house top-notch personnel experienced in FDA compliance and procedures.” 

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