NEW YORK – CDR-Life on Tuesday said the US Food and Drug Administration cleared its investigational new drug application for a clinical trial of the bispecific T-cell engager CDR404 as a treatment for solid tumors.
CDR404 targets the melanoma associated antigen 4 (MAGE-A4) protein, which is expressed in a number of difficult-to-treat solid tumor types. It was developed on the company's M-gager platform for targeting intracellular tumor antigens through the major histocompatibility complex.
In preclinical studies, treatment with CDR404 led to complete tumor regression in a squamous non-small cell lung cancer xenograft model, and a quantitative systems pharmacology model predicted doses of CDR404 that might have the best benefit-risk profile for patients in a Phase I trial.
A company representative said the Phase I study will be a basket trial in which CDR-Life will select patients with MAGE-A4-positive tumors.
"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," CDR-Life CEO Christian Leisner said in a statement.
The Zurich, Switzerland-based company is also advancing several other programs based on M-gager technology in solid tumor indications.