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CDR-life Announces FDA Clearance of the Investigational New Drug (IND) Application for CDR404 for the Treatment of Solid Tumors

Wednesday, January 24, 2024

CDR-Life Inc. made an announcement today regarding the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for CDR404. This is a noteworthy development for CDR404, the company's primary program designed as a precision immunotherapy for solid tumors.

In a groundbreaking move, CDR404 is described as an antibody-based, bivalent, and bispecific MAGE-A4 T-cell engager (TCE), utilizing the proprietary M-gager® technology. This technology is specifically designed to target intracellular tumor antigens via the major histocompatibility complex (MHC).

With the potential to serve as an off-the-shelf therapy, CDR404 aims to address the high unmet needs in multiple cancers expressing MAGE-A4, including non-small cell lung cancer (NSCLC), as stated by Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. Leisner expressed enthusiasm about reaching this significant milestone and emphasized the company's commitment to advancing additional programs that utilize the M-gager® technology against promising intracellular cancer targets. The ultimate goal is to enhance the lives of patients.

Looking ahead, the company plans to initiate Phase 1 trial enrollment in the coming months, marking a crucial step forward in bringing CDR404 closer to clinical application and potential patient benefits.



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