In collaboration with a contract manufacturing organization, Stem Cell Therapeutics (SCT) will begin the manufacturing process to generate drug for formal toxicology studies and a subsequent phase I clinical study, which is anticipated to begin in H2/2015.
SCT’s program targets the activity of CD47, a molecule upregulated on many leukemias and solid tumors. CD47 delivers a “do not eat” signal that suppresses macrophage phagocytosis, allowing cancer cells, including cancer stem cells, to escape immunemediated destruction. SCT has chosen to block the CD47 protein using a modified version of its natural ligand, SIRPα, fused to an immunoglobulin Fc region. The SIRPαFc fusion protein has shown excellent anti-leukemic activity both in vitro and in human xenograft models, and exhibits a unique binding profile compared to other CD47 blocking agents. These results, as well as encouraging safety data emerging from a recently completed non-human primate study, will be reported at a future scientific conference.
“We believe that SIRPαFc, through its ability to activate the innate immune response and eliminate cancer stem cells, holds great promise as a novel immunotherapy,” commented Dr. Niclas Stiernholm. “The transition from the research to the IND-enabling phase is a key milestone for the SIRPαFc program, and we will continue on the path towards clinical testing”.