Goodwin Biotechnology (GBI) of Plantation, Fla., and the University of Texas MD Anderson Cancer Center have collaborated 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.
GBI has already completed process development and is readying for the GMP manufacture of the drug conjugate. The GMP manufactured drug conjugate will subsequently be radiolabeled with 64Cu and evaluated in an early stage, human clinical trial. The fusion protein targets the tumor neovasculature, or blood supply, and inhibits tumor growth, and the DOTA chelator facilitates the subsequent labeling with a radioisotope for diagnostic imaging and/or therapeutics.
"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,” said Michael G. Rosenblum, Ph.D., head of immunopharmacology and targeted therapy laboratory, and director of research development in experimental therapeutics at MD Anderson.
"Contributing to such a medical advance is exciting," added Muctarr Sesay, PhD, vice president of process development, 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."