Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme

Core Viewpoint - Cue Biopharma has initiated a Phase 1b trial for CUE-102, targeting recurrent glioblastoma multiforme (rGBM), with the first patient dosed at Dana-Farber Cancer Institute [1][2] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing therapeutic biologics that engage and modulate disease-specific T cells for treating autoimmune diseases and cancer [1][6] - The company utilizes its proprietary Immuno-STAT® platform to harness the immune system's potential without broad systemic immune modulation [6] Product Details - CUE-102 is designed to activate and expand Wilms' Tumor 1 (WT1)-specific T cells, targeting cancers that express the WT1 protein [3] - The drug has shown anti-tumor activity and a favorable tolerability profile in previous trials, with no dose-limiting toxicities reported [3] Clinical Trial Information - The Phase 1b trial (NCT06917885) aims to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence [1] - The principal investigator, Dr. David A. Reardon, is a leader in immunotherapy for brain cancer [1][2] Industry Context - Glioblastoma is recognized as one of the most aggressive and difficult-to-treat cancers, with approximately 13,000 new cases diagnosed annually in the U.S. [4] - The average survival time post-diagnosis is around 12 to 15 months, with only 3 to 5 percent of patients surviving beyond five years [4] Mechanism of Action - CUE-102 operates by presenting the WT1 peptide to WT1-specific T cell receptors, aiming to enhance the anti-tumor immune response [2][3] - The CUE-100 series biologics provide two signals to T cells: a tumor-specific peptide and a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation [5]