CDR-Life Announces Pipeline Progress of M-gager® Programs for Treatment of Solid Tumors

CDR404 and CDR813: First-of-its-kind antibody-based T cell engagers targeting intracellular tumor antigens MAGE-A4 and PRAME via the major histocompatibility complex

First patient treated with MAGE-A4-targeting CDR404; presentation at ESMO showcases potential of PRAME-targeting CDR813 to exhibit best-in-class characteristics in the clinic

ZÜRICH--(BUSINESS WIRE)--CDR-Life today announced significant clinical progress in its M-gager^® portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibody-fragment based immunotherapies for difficult-to-treat cancers.

First patient dosed with CDR404
The first patient was dosed with CDR404, a novel, bispecific and bivalent antibody fragment-based T cell engager (TCE) targeting MAGE-A4, an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells.

The Phase 1 study (NCT06402201) is enrolling HLA-A *02:01+ patients with MAGE-A4+ solid cancers in the U.S. and Europe. The trial is evaluating the safety, tolerability and preliminary anti-tumor activity of CDR404 in several common cancers including squamous cell carcinomas in which MAGE-A4 is highly enriched.

New clinical candidate targeting PRAME
Preferentially Expressed Antigen in Melanoma (PRAME) is a tumor-specific therapeutic target that is expressed in a wide range of solid tumors including lung, ovarian, melanoma, and endometrial cancers, while exhibiting only minimal expression in healthy tissues.

CDR-Life has identified and characterized an antibody fragment-based TCE as a clinical candidate targeting PRAME called CDR813. This TCE binds potently and bivalently to an HLA-A*02-restricted PRAME peptide on the surface of cancer cells. Pre-clinical studies have shown that CDR813 has very favorable pharmacological and manufacturability properties with best-in-class potential for the clinic.

A poster will be presented at the 2024 European Society for Medical Oncology (ESMO) Congress, in Barcelona, Spain.

Poster Presentation Details
Title: Highly potent and specific bivalent T cell engager (TCE) targeting PRAME on HLA-A*02:01
Date and Time: Saturday, September 14, 2024, 12 – 1 pm CET
Abstract Number: 5132, Poster 1020P

“The clinical advancement of CDR404 and the excellent progress we have made in advancing CDR813 into a clinically viable drug are significant milestones in our quest to develop life-changing, antibody fragment-based cancer medicines for patients with the HLA-A*02:01 genotype, the most prevalent HLA genotype in the U.S. and Europe, using our proprietary M-gager technology," said Swethajit Biswas, Chief Medical Officer of CDR-Life. “This current suite of T cell engagers targeting cancer-specific peptides presented on HLA underscores our ambitions in solid tumor oncology to create an innovative pipeline of highly specific and potent antibody fragment-based molecules targeting a wide range of cancer-specific antigens including challenging cell surface resident proteins, which are known to be directly involved in tumor growth.”

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 but cancer-specific intracellular and surface antigens through unparalleled target-specificity. 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.