Tofacitinib Citrate

Novel M-gager® candidate designed to selectively target TRBV9-positive autoreactive T cells while preserving normal immune function, with potential applicability across HLA-B27-associated autoimmune diseases ZURICH, Switzerland--(BUSINESS WIRE)-- CDR-Life, Inc. , a clinical-stage biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, today announced its newest development candidate, CDR209, a novel T cell engager for the treatment of axial spondyloarthritis (axSpA) and potentially other HLA-B27 associated autoimmune diseases. Built on the company's proprietary M-gager® platform, CDR209 is designed to redirect healthy T cells to selectively eliminate TRBV9-positive autoreactive T cells, which have recently been shown to drive disease in many patients with HLA-B27-associated axSpA i . By targeting this small population of pathogenic T cells while preserving approximately 95% of healthy T cells and other immune cells, CDR209 aims to address an underlying driver of disease without the broad immune suppression associated with conventional therapies. "Patients with axial spondyloarthritis continue to need better treatment options," said Christian Leisner, Ph.D., Chief Executive Officer of CDR-Life. "While current therapies have improved disease management, many patients continue to experience active disease despite treatment. CDR209 represents an important step in expanding our M-gager platform into autoimmune disease and reflects our commitment to developing highly selective T cell engagers designed to address disease with greater depth and precision." Axial spondyloarthritis is a chronic inflammatory disease that primarily affects the spine and sacroiliac joints and is estimated to affect up to 2.7 million adults in the United States. ii Although treatment options have expanded over the past two decades, many patients do not achieve adequate disease control with currently available therapies. Standard treatment begins with nonsteroidal anti-inflammatory drugs (NSAIDs) and may progress to biologic therapies such as TNF, IL-17 or JAK inhibitors. Published studies suggest that only about 40–50% of patients with axSpA achieve an ASAS40 response (a standard measure of meaningful improvement in disease signs and symptoms), with currently approved biologic therapies, underscoring the need for additional treatment options. iii “Axial spondyloarthritis, historically referred to as ankylosing spondylitis, often begins early in adulthood and can have a substantial long-term impact on mobility, work and overall quality of life. Although current therapies can control inflammation and symptoms in many patients, they generally require continuous treatment and do not specifically eliminate the immune cells that may be driving the disease,” said Denis Poddubnyy, M.D., Ph.D., Professor of Medicine and Director of the Division of Rheumatology, Temerty Faculty of Medicine, University of Toronto. “There is growing interest in approaches that target selected populations of disease-associated immune cells, such as TRBV9-positive T cells, which appear to play an important role in the immune response underlying axial spondyloarthritis. Selectively removing these cells, while preserving the broader immune system, raises the possibility of interrupting the disease process at a more fundamental level. The longer-term goal is to determine whether such an immunological reset can translate into durable disease control or even treatment-free remission.” In preclinical studies, CDR209 demonstrated high-affinity binding to TRBV9, potent and selective depletion of TRBV9-positive T cells, and no detectable depletion of non-target T-cell populations. The clinical candidate has also demonstrated favorable developability characteristics supporting continued preclinical development. CDR209 expands CDR-Life's growing pipeline of T cell engager therapies for autoimmune diseases and complements the company's oncology portfolio, including CDR404, which is currently being evaluated in a Phase 1 clinical trial in patients with MAGE-A4-positive solid tumors. About CDR209 CDR209 is a first-in-class T cell engager designed to selectively eliminate the TRBV9-positive autoreactive T cells implicated in axial spondyloarthritis. Developed using CDR-Life's proprietary M-gager® platform, CDR209 is intended to preserve the broader immune system while targeting disease-driving cells including deep in tissues. 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 clean targets through unparalleled binding-specificity. With our first oncology program now in clinical trials, we are advancing a pipeline of potent and selective TCE therapeutics. Our longstanding collaboration with Boehringer Ingelheim on a molecule derived from our M-gager® platform, now in Phase 2, demonstrates the potential of our antibody-derived molecules. The partnership between the companies expanded further in 2025 through a new global licensing agreement to develop a trispecific M-gager for autoimmune diseases. Backed by leading cross-Atlantic investors, our team is committed to bringing life-changing, disease-modifying medicines to patients globally. Learn more at i Britanova OV, Lupyr KR, Staroverov DB, et al. Targeted depletion of TRBV9+ T cells as immunotherapy in a patient with ankylosing spondylitis. Nat Med. 2023;29:2731–2736. doi:10.1038/s41591-023-02613-z; Nasonov EL, Mazurov VI, Lila AM, et al. The Efficacy and Safety of BCD-180, an Anti-TRBV9+ T cell Monoclonal Antibody, in Patients with Active Radiographic Axial Spondyloarthritis: 36-week Results from the Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study ELEFTA. Dokl Biochem Biophys. 2025;522:387-403. doi:10.1134/S1607672925700140 ii Reveille JD, Witter JP, Weisman MH. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care & Research (Hoboken) . 2012;64(6):905-910 iii Adalimumab (ABILITY-1): ASAS40 ≈ 36% at week 12 ( ) Upadacitinib (SELECT-AXIS 2 nr-axSpA): ASAS40 45% at week 14 (AbbVie press release ) Secukinumab: ASAS40 at week 16 were 42% and 33% in the groups that received s.c. secukinumab at the higher and lower doses, respectively ( ) Tofacitinib: ASAS40 at week 16 was 40.6% ( ) Contacts Media: Lauren Arnold LA Communications Lauren@lacommunications.net Investors: Christian Leisner CDR-Life Inc. Christian.Leisner@cdr-life.com