Patient dosing has begun in Biothera Pharmaceuticals Inc.'s Phase 1b/2 clinical study at the Big Ten Cancer Research Consortium to evaluate Biothera’s Imprime PGG in combination with the Merck anti-PD-1 therapy, Keytruda (pembrolizumab), in second-line non-small cell lung cancer (NSCLC).
According to Biothera, the University of Illinois at Chicago will initiate patient enrollment – the first Big Ten site to do so. Four other universities from the Big Ten will be included at a later date. Additionally, funding and clinical supplies of Keytruda are being provided by Merck, which is known as MSD outside the United States and Canada.
“While we have seen great advances in the field of cancer immunotherapy, we want to address the significant continuing need among patients, including those with refractory disease,” Dr. Lawrence Feldman, principal investigator of the NSCLC study at the UI Health Cancer Center, said in a statement. “This new trial brings together a promising combination approach that we believe may increase patient responses to Keytruda and ultimately improve the lives of patients with non-small cell lung cancer.”
“Our extensive translational research indicates there is a significant opportunity for the combination of Imprime PGG and Keytruda to benefit second-line patients with non-small cell lung cancer,” Dr. Bruno Osterwalder, Biothera Pharmaceuticals’ chief medical adviser, said.