CDR-Life AG

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 the appointment of Sarah Holland, PhD, as Chief Business Officer. Drawing on her over 30 years of biopharmaceutical industry expertise, Dr. Holland will spearhead CDR-Life’s business development initiatives and commercial strategy, focusing on advancing its innovative M-gager® platform to develop T cell engager (TCE) therapies for patients with cancer and autoimmune diseases. “Sarah's distinguished career reflects her unique ability to bridge scientific innovation and business strategy. Her leadership and proven expertise arrive at an inflection point for CDR-Life as we advance our clinical program in solid cancers and build momentum in the autoimmune space,” said Christian Leisner, PhD, CEO and founder of CDR-Life. “We are excited about Sarah joining our leadership team and she will play a pivotal role as we harness our M-gager platform to develop breakthrough therapies for both cancers and autoimmune conditions.” Dr. Holland has more than 30 years of biopharma experience, most recently serving as Chief Business Officer of Cureteq. She previously served as Chief Business Officer of VectivBio during its IPO on NASDAQ and drove the acquisition and integration of Comet Therapeutics as well as a partnering deal with Asahi Kasei. Previously, Dr. Holland was Global Head of Licensing and Head of R&D at Lonza and led the External Science and Partnering team at Sanofi. She held positions of increasing responsibility with Roche for over a decade, where she drove notable deals in oncology and central nervous system (CNS) and built and led the M&A assessment and integration team. In her last role at Roche, Sarah was the Lifecycle Leader for Alecensa during FDA and EMA submission. Prior to Roche, she held commercial roles in diagnostics, biotech and pharma, culminating in the global launch of Faslodex for AstraZeneca. Dr. Holland also serves as President of the Swiss Healthcare Licensing Group. "With its T cell engager therapy, CDR-Life is a true industry standout and I look forward to leveraging my experience and background to help realize the full potential of the M-gager platform and expand our therapeutic reach. This is an incredibly exciting phase of growth for CDR-Life and I am thrilled to be part of the talented team working to deliver innovative solutions for patients with serious unmet medical needs,” said Dr. Holland, Chief Business Officer of CDR-Life. 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. 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 .

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 .