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CDR-Life Presents Promising Preclinical Data for Novel T Cell Engager Programs at AACR Annual Meeting 2025

via Business Wire

Data demonstrate potential superiority of antibody-based T cell engager CDR404 over TCR-based approaches, consistent with emerging Phase 1 trial signals of immunological activity and preliminary anti-tumor effects

CDR-Life today announced the presentation of data for its novel T cell engager (TCE) programs at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago. The presentations showcase the company's proprietary M-gager® platform-derived TCE candidates, with a focus on CDR404, currently in Phase 1 clinical trials for MAGE-A4-positive solid tumors.

“The data presented at AACR highlight the potential advantages of our antibody-based approach to T cell engagement against highly tumor-specific targets,” said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. “CDR404 demonstrated superior potency and durability in preclinical models, which align with the encouraging early signals we're seeing in our ongoing Phase 1 trial.”

Key Findings for CDR404 in MAGE-A4-Positive Tumors (Abstract #3494)

The poster, “Durable and potent in vitro T cell activity with repeated exposure to CDR404, a potential best-in-class T cell engager targeting MAGE-A4” demonstrated several advantages of CDR404 compared to a TCR-based TCE:

  • Superior Potency and Durability: CDR404 showed more potent killing of MAGE-A4-positive cancer cell lines across multiple indications, even at low effector-to-target cell ratios which mimic a “cold” tumor environment, compared to a TCR-based competitor
  • Enhanced T Cell Fitness: After multiple rounds of serial killing, T cells exposed to CDR404 maintained significantly better fitness, with lower levels of crucial T cell exhaustion markers compared to the TCR-based approach
  • Favorable Cytokine Profile: CDR404 demonstrated a more favorable cytokine release profile, potentially offering safety advantages in the clinical setting
  • Effective Across Multiple Cancer Types: CDR404 showed strong activity against MAGE-A4-positive tumor cells from different cancer types, including lung adenocarcinoma and squamous cell carcinoma, and melanomas

The data presented in the poster align well with early emerging data from the ongoing Phase 1 trial of CDR404 (NCT06402201). CDR404 has shown clear signals of immunological activity and preliminary evidence of anti-tumor activity, including at the pharmacokinetic model-derived starting dose. Use of this innovative model created an elevator to a higher starting dose, potentially shortening overall trial duration by enabling a starting dose closer to the efficacious dosing range while maintaining patient safety. Dose escalation is ongoing and patient data from the early stages of the Phase 1 trial will be reported later this year.

Second T Cell Engager for KK-LC-1-Positive Tumors (Abstract #3493)

In the poster, “A novel T cell engager antibody for the treatment of HLA-A01/KK-LC-1-positive tumors,” CDR-Life presented data on CDR505, a novel antibody-based TCE targeting the Kita-Kyushu lung cancer antigen-1 (KK-LC-1) presented on HLA-A01:01.

Key findings for CDR505 included:

  • Potent and Selective: CDR505 demonstrated potent and selective killing of KK-LC-1-positive cancer cells.
  • Preferential T Cell Activation: The molecule showed preferential activation of CD8+ T cells, confirming the intended mechanism of action.
  • High Target Specificity: CDR505 exhibited high specificity for the KK-LC-1 peptide/HLA-A*01:01 complex, demonstrating low risk for off-target binding.
  • Desirable Pharmaceutical Properties: The molecule demonstrated excellent manufacturability, solubility and stability characteristics, supporting its feasibility for subcutaneous formulation.

Broad Patient Potential

Both TCE candidates have the potential to address significant patient populations:

  • CDR404 targets MAGE-A4-positive tumors in HLA-A02:01-positive patients. MAGE-A4 is expressed in up to 63% of ovarian cancers, 62% of head and neck cancers and 52% of squamous lung cancers.
  • CDR505 is the only TCE in development targeting KK-LC-1-positive tumors in HLA-A*01:01-positive patients. KK-LC-1 is expressed in 75% of colorectal and gastric carcinoma cancers and 60% of pancreatic ductal adenocarcinoma cancers.

“With CDR505, we're breaking new ground in targeting previously inaccessible cancer antigens through our innovative M-gager® platform,” added Dr. Leisner. “This first-in-class molecule demonstrates how we're tackling difficult targets with precision, particularly in tumor types where traditional approaches have shown limited success. The widespread expression of KK-LC-1 across gastrointestinal cancers positions CDR505 to potentially address some of medicine's most challenging malignancies with a novel immunotherapeutic approach.”

About CDR-Life

CDR-Life develops highly targeted T cell engagers (TCEs) for the treatment of solid cancers and autoimmune diseases. Our M-gager® platform delivers TCEs against challenging intracellular and surface antigens through unparalleled target-specificity. With our first oncology program now in clinical trials, we are advancing a pipeline of potent and selective TCE therapeutics. Our partnership with Boehringer Ingelheim on a molecule derived from our M-gager® platform, progressing to Phase 2 trials, demonstrates the potential of our antibody-derived molecules. Backed by leading cross-Atlantic investors, our team is committed to bringing life-changing, disease-modifying medicines to patients globally. Learn more at www.cdr-life.com.

“The data presented at AACR highlight the potential advantages of our antibody-based approach to T cell engagement against highly tumor-specific targets,” said Christian Leisner, PhD, Chief Executive Officer of CDR-Life.

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