CDR-Life Announces FDA Clearance of IND Application for CDR404 for Treatment of Solid Tumors

January 23, 2024 12:00 pm Published by

First-of-its-kind, antibody-based, bivalent and bispecific MAGE-A4 T-cell engager

Zürich, Switzerland, January 23, 2024 – 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. 

About CDR-Life

CDR-Life is developing highly specific antibody therapeutics to target intracellular proteins presented on the major histocompatibility complex (MHC). Our versatile MHC-targeted antibody platform increases access to a vast array of antigens that were not previously addressable, to develop a pipeline of first in class therapeutics across a broad range of solid tumors. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to redirect and activate the patient’s own immune system to eliminate their tumors.


Holly Hancock
MacDougall Advisors

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