On October 23, 2025 CDR-Life, Inc., a biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported the first clinical data showing that CDR404, the company’s lead M-gager TCE, achieved all four canonical pharmacodynamic (PD) hallmarks of TCE activity in patients with MAGE-A4+ solid tumors. The data, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), in Boston, Massachusetts, highlights CDR404’s robust immune activation and early signals of clinical activity, including tumor stabilization and biomarker improvements in patients with ovarian cancers and synovial sarcomas.

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CDR404 is an antibody-based TCE designed to target intracellular tumor antigens presented on HLA molecules. It engages MAGE-A4 peptides displayed by HLA-A*02:01 on cancer cells and redirects CD3+ T cells for targeted tumor cell killing. The ongoing Phase 1 CDR404 trial (NCT06402201) is being conducted at leading cancer centers across the United States and Europe. Unlike conventional approaches utilizing T cell receptors, the proprietary M-gager platform leverages antibody-derived binding domains that combine exceptional specificity with strong potency, excellent developability and ease of manufacturing.

At initial dose levels of 100–200 μg, CDR404 triggered the full cascade of immune activation associated with effective TCE therapy, including CD8+ T cell activation and expansion, reprogramming to a memory phenotype and recruitment of lymphocytes into tumors. Notably, repeated dosing did not induce PD-1–mediated T cell exhaustion, suggesting sustained biological activity. In one patient, a transient tumor flare followed by stabilization was observed, which is consistent with tumor infiltration by cytotoxic T cells.

"These early data demonstrate that our M-gager platform can extend the precision and power of antibody-based T cell engagers to intracellular antigens, an area long thought to be accessible only to TCR-based modalities," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Seeing all four pharmacodynamic hallmarks of activity in patients even at low doses underscores the potential of this approach to redefine how we target solid tumors."

The study’s first-in-human dose was guided by quantitative systems pharmacology modeling, enabling detection of pharmacodynamic effects more quickly than traditional approaches. Based on these encouraging signals, the trial will begin to focus on patients with MAGE-A4–positive ovarian cancers, a population with high unmet need.

Additional analyses, including integrated pharmacokinetic-pharmacodynamic and circulating tumor DNA (ctDNA) data, are ongoing.

Presentation Details:
Title:

Hallmarks of pharmacodynamic activity of CDR404, a new antibody-derived T cell engager (TCE) targeted against MAGE-A4+ solid tumors in HLA-A02:01+ patients

Presenter:

Melissa Vrohlings, Head of Translational Science, CDR-Life

Date and Time:

October 23, 2025 | 12:30 – 4 pm ET

Location:

Poster Session A

Level 2, Exhibit Hall D

In addition to the poster presentation on CDR404, CDR-Life is also presenting a poster on CDR609, the company’s newest T cell engager clinical candidate that targets LGR5, a highly cancer-specific cell surface antigen widely expressed on common solid tumors.

Presentation Details:

Title:

CDR609: A First-in-Class LGR5-targeted T Cell Engager for treatment of Colorectal Cancer and other solid tumors

Presenter:

Sophie Barsin, Project Leader, CDR-Life

Date and Time:

October 23, 2025 | 12:30 – 4 pm ET

Location:

Poster Session A

Level 2, Exhibit Hall D

(Press release, CDR-Life, OCT 23, 2025, View Source [SID1234656966])