CDR-Life Inc. today announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CDR404, its lead program in development as a precision immunotherapy for solid tumors.
First of its kind, CDR404 is an antibody-based, bivalent and bispecific MAGE-A4 T-cell engager (TCE) based on the company’s unique M-gager® technology for targeting intracellular tumor antigens through the major histocompatibility complex (MHC).
“CDR404 holds the potential to become the off-the-shelf therapy for multiple cancers expressing MAGE-A4 with high unmet need, including non-small cell lung cancer (NSCLC),” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “We are thrilled to achieve this milestone and are continuing to advance several additional programs leveraging our M-gager® technology against promising intracellular cancer targets with the goal of improving patient lives.”
The company anticipates initiating Phase 1 trial enrollment in the coming months.