CDR-Life AG

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 .

INGELHEIM, Germany and BASEL, Switzerland I September 5, 2024 I Boehringer Ingelheim and CDR-Life today announce positive results from the Phase I evaluation of BI 771716 ( Study Record | ClinicalTrials.gov ), an investigational antibody fragment developed to preserve vision in people living with geographic atrophy (GA). BI 771716 met its primary safety endpoint following intravitreal administration of single and multiple doses. Preparation for the Phase II trial is now underway, with an expected start date in early 2025. GA is an advanced and severe form of late-stage, dry age-related macular degeneration (AMD), a chronic and progressive retinal disease, that can lead to irreversible and permanent vision loss. 1 It is a leading cause of blindness, affecting more than five million people worldwide, of which more than 40% are considered blind. 1-3 Vision loss associated with GA severely impacts the independence, mental health and quality of life of those living with the condition. 4 Current treatments have limited efficacy and availability. BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy. “We are delighted to have achieved a critical milestone in our development of BI 771716, and are now preparing a Phase II clinical study to investigate efficacy and dosing,” said Heiko Niessen, Ph.D., Global Therapeutic Area Head Translational Medicine & Clinical Pharmacology Retinal Health at Boehringer Ingelheim. “BI 771716 is part of our comprehensive retinal portfolio demonstrating our long-term commitment to preserving both eyesight and quality of life in people with retinal diseases.” “Reaching this safety milestone is a significant step forward for this compound, highlighting the strength of our partnership with Boehringer Ingelheim,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Having successfully met all four planned milestones so far, we’re optimistic about the continued development of this innovative antibody fragment-based therapy and its potential to provide clinical benefit in geographic atrophy.” “The development of new therapies for geographic atrophy remains one of the most important needs in the age related macular degeneration space,” said Charles C. Wykoff, MD, Ph.D., Principal Investigator of the Phase I trial, Director of Research at Retina Consultants of Texas; Chair of Research, Retina Consultants of America; and Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital. “Achieving the Phase I safety endpoint is a meaningful step forward for this potential new treatment for people with this sight-threatening and life-affecting condition.” CDR-Life and Boehringer Ingelheim announced their collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed on all milestones to date. Notes to Editors: About the trial (NCT06006585) Study Record | ClinicalTrials.gov The Phase I trial measured the safety, tolerability, and pharmacokinetics of intravitreal single rising doses and multiple doses of BI771716 in patients with geographic atrophy aged 50+. The purpose of the study was to determine how well different doses of BI 771716 are tolerated. This study had two parts. Single rising dose (SRD) Participants received one injection of BI 771716 directly into one of the eyes affected by geographic atrophy. The primary endpoint was the number of patients with ocular dose-limiting events (DLEs) from drug administration until Day 8; secondary endpoints included occurrence of any ocular adverse events (AEs) and maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax). Multiple dose (MD) Participants received two injections of BI 771716 directly into the eye. There were 4 weeks between the first and the second injection. Detailed study results will be made available in the coming months. About BI 771716 BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. BI 771716 is part of Boehringer Ingelheim’s research and development portfolio in retinal conditions. About Geographic Atrophy (AMD) AMD is an age-related disease of the central portion of the retina (the macula) which is responsible for high visual acuity that allows for color vision, reading and facial recognition. 4 Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss. 4 More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind. 1-3 From age 50 years, the prevalence of GA quadruples every 10 years. 5 Consequently, rising incidences are expected in aging populations. People with GA experience moderate to severe central vision loss, which can impact daily life activities such as driving, shopping alone, reading, finding street signs and a wide range of social and manual activities that require fine motor control. 4 These limitations can lead to a loss of independence and social isolation, which in turn can have an impact on mental health, leading to depression, fear and anxiety. 4 About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com . About CDR-Life CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. References SOURCE: Boehringer Ingelheim

CDR813 and CDR505 programs further broaden pipeline of cancer-specific targeted therapies ZÜRICH, Switzerland I June 25, 2024 I CDR-Life Inc. today announced an expansion of its pipeline of novel T cell engagers (TCE) with the addition of CDR813 and CDR505. CDR813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*02:01 patients. PRAME is a clinically validated pan-cancer target expressed in a broad set of tumors including non-small cell lung cancer (NSCLC), endometrial cancer, melanoma and ovarian cancer, but not in normal tissue. A bi-valent and bi-specific antibody-based TCE, CDR813 targets a PRAME peptide presented on tumor cells by the HLA-A*02 complex and the CD3 receptor on T-cells with unparalleled potency and specificity. CDR505 is a TCE targeting KK-LC-1, a novel HLA-A*01 target relevant in common cancer populations not yet addressed by other T cell receptor (TCR) therapeutics. While most TCE programs target the HLA-A02 haplotype, CDR505 targets KK-LC-1/HLA-A*01, expanding the potential of TCEs to benefit a large patient population with high unmet need. Preclinical data on CDR505 was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2024. “With our continued investment in building a broad pipeline of unique, potent and highly cancer-targeted therapies, we are expanding the promise of our differentiated T cell engager platform to treat a range of solid tumors,” said Christian Leisner, Ph.D., Chief Executive Officer at CDR-Life. “Importantly, the CDR813 and CDR505 programs are geared toward populations with significant unmet medical need, increasing our reach to benefit more patients.” About CDR-Life CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors. SOURCE: CDR-Life