Cue Biopharma Presents Positive Updated Data from its Phase 1 Trials of CUE-101 and CUE-102 in Head and Neck Cancer and WT1 Positive Cancers at the SITC 39th Annual Meeting

Core Insights - Cue Biopharma presented promising clinical data for its lead oncology asset CUE-101 in combination with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients, showing an objective response rate (ORR) of 46% and a 12-month overall survival (OS) of 91.3% [1][3] - The company also reported a 67% overall disease control rate (DCR) for its second clinical asset CUE-102 in late-stage pancreatic cancer patients, indicating significant anti-tumor activity [1][5] CUE-101 Clinical Trial Data - CUE-101 demonstrated an ORR of 46% and a DCR of 75% in first-line HPV+ R/M HNSCC patients, significantly outperforming the historical ORR of 19% with pembrolizumab alone [3] - The median overall survival (mOS) for patients treated with CUE-101 was 21.8 months, compared to 12.3 months in historical trials [4] - In patients with low PD-L1 expression (CPS 1-19), the ORR reached 50% [1][3] CUE-102 Clinical Trial Data - CUE-102 showed a 67% overall DCR in late-stage pancreatic cancer patients, including an unconfirmed partial response with a 40% decrease in tumor burden [1][5] - Evidence of selective expansion of WT1-specific T cells was observed, with no dose-limiting toxicities reported during the trial [6][10] Mechanism of Action - The CUE-100 series, including CUE-101 and CUE-102, utilizes a novel mechanism to selectively engage and modulate disease-specific T cells, enhancing the immune response against tumors [8][11] - CUE-101 is designed to activate HPV16 tumor-specific T cells, while CUE-102 targets WT1-specific T cells, both aiming to improve patient outcomes in various cancers [9][10] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a new class of therapeutic biologics to modulate T cells for cancer and autoimmune diseases [11][12] - The company’s proprietary Immuno-STAT platform aims to harness the body's immune system while minimizing adverse effects associated with traditional therapies [11]