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Generation Bio to Apply ctLNP Delivery Technology to Develop siRNA Therapeutics for T Cell-Driven Autoimmune Diseases

Core Viewpoint - Generation Bio is advancing its T cell-directed lipid nanoparticle (ctLNP) technology to develop siRNA therapeutics aimed at treating T cell-driven autoimmune diseases, with plans to submit its first Investigational New Drug (IND) application in the second half of 2026 [1][3][7]. Group 1: Technology and Development - The company is utilizing its validated ctLNP to deliver siRNA specifically to T cells, aiming to silence disease-driving targets without affecting other immune cell types [2][9]. - Generation Bio's ctLNP technology has shown strong selectivity for CD8+ and CD4+ effector T cells and NK cells, which are involved in auto-reactive tissue damage in autoimmune diseases [2][3]. - The ctLNP-siRNA approach is designed to modulate T cell functions that lead to inflammation and tissue damage, potentially addressing high-value, currently undruggable targets [3][7]. Group 2: Clinical Plans and Timeline - The company plans to enter clinical trials within its cash runway, which extends into the second half of 2027, following the submission of its first IND in late 2026 [2][3]. - Generation Bio is reorganizing to support the clinical development of its T cell-directed therapies, indicating a strategic shift towards clinical capabilities [3][7]. Group 3: Leadership Changes - The company announced changes in its executive leadership team, with Phillip Samayoa, Ph.D., becoming the new chief scientific officer, and Kevin Conway being appointed as chief financial officer [4][5]. - Matthew Stanton, the outgoing chief scientific officer, will transition to the Scientific Advisory Board, while Matthew Norkunas, M.D., will remain until mid-2025 [4][5].