CDR-404

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 ZURICH, Switzerland I April 25, 2025 I 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: 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: Broad Patient Potential Both TCE candidates have the potential to address significant patient populations: “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 . SOURCE: CDR-Life

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 .