Core Viewpoint - Cue Biopharma, Inc. is advancing its clinical-stage drug candidate CUE-101, which shows promising results in treating recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab, indicating a potential breakthrough in therapeutic approaches for autoimmune diseases and cancer [1][2][4]. Clinical Update - An additional complete response (CR) was reported in a patient with recurrent metastatic HPV+ HNSCC treated with CUE-101 and pembrolizumab, demonstrating significant tumor reductions and a durable stable disease for nearly two years [2]. - The overall response rate (ORR) in patients with a combined positive score (CPS) ≥1 is 50%, including a 50% ORR in patients with low CPS (1-19) [8]. - The 12-month overall survival rate is 88%, with a median overall survival (mOS) of 32 months, compared to 57% and 12.3 months, respectively, in the historical KEYNOTE-048 trial [9]. Drug Mechanism and Development - CUE-101 is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals: the HPV E7 protein for selectivity and an engineered IL-2 variant to stimulate T cell activity [5]. - The drug is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study for HPV16+ driven recurrent/metastatic HNSCC as both a monotherapy and in combination with pembrolizumab [5]. Company Overview - Cue Biopharma is focused on developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells, utilizing its proprietary Immuno-STAT platform [6]. - The company is headquartered in Boston, Massachusetts, and is led by a management team with extensive expertise in immunology and immuno-oncology [7].