CDR404
Urgent need for new therapies in solid tumors
MAGE-A4 is commonly overexpressed in difficult-to-treat solid tumors including non-small cell lung, head and neck, synovial sarcoma, bladder, and gynecological malignancies. Redirecting T cell migration towards MAGE-A4 positive tumors is likely to be an important treatment option for these patients.
What is MAGE-A4?
Melanoma-associated antigen A4 (MAGE-A4) is a protein that has minimal or no presence in healthy tissue but exhibits increased expression in several solid tumors. Tumor cells display MAGE-A4 fragments on their cell membrane via the Human Leukocyte Antigen (HLA) protein.
CDR404 – a novel molecule for cancer treatment
Currently, cancer-specific proteins such as MAGE-A4 can only be targeted by highly complex treatments, like engineered cell therapies, which are individualized and expensive to manufacture and produce. CDR404 is a potent off-the-shelf treatment and is a first-of-its-kind, antibody-based MAGE-A4 T cell engager for MAGE-A4 positive solid tumors.
Phase 1 clinical trial of CDR404 in solid tumors – recruiting
The CDR404-001 trial is evaluating the safety, tolerability, pharmacokinetics, and initial signs of clinical efficacy of CDR404. This first-in-human study is an open-label, multi-center trial, investigating escalating doses of CDR404 in patients who are positive for HLA-A*02:01 with solid tumors expressing MAGE-A4. Further information can be found at NCT06402201 or contact CDR404-001_Study@CDR-Life.com.
CDR609 – A Novel M-gager® Targeting LGR5+ Solid Tumors
Urgent need for new therapies in solid tumors
Epithelial solid tumors account for the vast majority of cancer diagnoses worldwide, and many remain difficult to treat in advanced or metastatic settings where relapse and therapeutic resistance are common.
LGR5 expression has been documented across several high-incidence solid tumor types, including colorectal, gastric, pancreatic and hepatocellular cancers, as well as subsets of lung and breast cancers. In colorectal and gastric cancer in particular, LGR5-positive tumor cell populations are frequently observed and have been associated with tumor growth, progression, metastasis and recurrence following standard therapies.
The breadth of high LGR5 expression across multiple common epithelial malignancies, combined with its association with stem-like tumor biology, positions LGR5 as a compelling target with potential applicability across a meaningful segment of the solid tumor landscape.
Redirecting T cell activity toward LGR5-expressing tumor cells may offer a differentiated therapeutic approach for patients with limited treatment options.
What is LGR5?
Leucine-rich repeat-containing G protein-coupled receptor 5 (LGR5) is a cell surface protein expressed on subsets of tumor cells in several epithelial cancers. LGR5 has been linked to stem-like tumor cell populations that may contribute to disease persistence, treatment resistance and tumor regrowth after standard therapies.
Importantly, LGR5 expression in normal adult tissues is highly restricted and primarily confined to very low levels on specific stem cell niches, making it an attractive surface antigen for selective tumor targeting. Because LGR5 is expressed on the cell membrane, it is directly accessible to antibody-based therapies designed to engage immune effector cells.
CDR609 – A novel molecule for cancer treatment
CDR609 is a next-generation, antibody-based M-gager® T cell engager designed to selectively redirect T cells to LGR5-expressing tumor cells. By combining high-specificity tumor targeting with controlled CD3 engagement, CDR609 is engineered to drive potent tumor cell killing while maintaining a favorable therapeutic window.
CDR609 leverages the M-gager platform’s antibody-derived binding domains to deliver strong developability and scalable manufacturing. The program expands CDR-Life’s oncology pipeline beyond intracellular peptide-HLA targets, demonstrating the versatility of the M-gager platform to address both intracellular and surface tumor antigens.
CDR-Life is advancing CDR609 toward an Investigational New Drug (IND) application targeted for the end of 2026.