Goodwin Biotechnology, Inc. (GBI) and The University of Texas MD Anderson Cancer Center jointly will collaborate on process development and GMP manufacturing of a fusion protein composed of a vascular endothelial growth factor (VEGF) and the recombinant toxin, Gelonin (rGel), conjugated to a DOTA chelator. The fusion protein targets the tumor neovasculature, or blood supply, and inhibits tumor growth, while the DOTA chelator facilitates the subsequent labeling with a radioisotope for diagnostic imaging and/or therapeutics.
GBI has completed process development and is readying for the GMP manufacture of the drug conjugate. The GMP-manufactured conjugate will subsequently be radiolabeled with 64Cu and evaluated in an early stage clinical trial.
"I have worked with GBI for more than 10 years producing antibody-drug conjugates, and have been impressed with their bioconjugation expertise and the service they provide," said Michael G. Rosenblum, Ph.D. professor of Medicine, head of the Immunopharmacology and Targeted Therapy Laboratory and director of Research Development in the Experimental Therapeutics department at MD Anderson. "The conjugate we are developing will hopefully enhance our ability to detect and treat primary cancers sooner, but it may also more accurately identify and inhibit metastatic spread earlier in the course of the disease."
"Contributing to such a medical advance is exciting," said Muctarr Sesay, Ph.D., vice president of Process Development at GBI. "We have a long history of collaborating with Dr. Rosenblum and MD Anderson for GMP manufacturing of therapeutic antibody-drug conjugates that have been used in human clinical trials. With the current project, we are also leveraging our extensive experience with preparing conjugates for subsequent radioisotope labeling to develop this important product for diagnostic and therapeutic applications."