Cue biopharma initiates patient dosing in phase 1 study of cue-101 for hpv16-driven head and neck squamous cell carcinoma

Cue biopharma, inc. announced that on september 23, 2019 it dosed the first patient in a phase 1 clinical trial of cue-101 at washington university, alvin j. siteman cancer center, st. louis, missouri for the treatment of hpv16-driven recurrent/metastatic head and neck squamous cell carcinoma (hnscc). enabled by the company’s proprietary immuno-stat™ (selective targeting and alternation of t cells) platform, cue-101 is the company’s lead biologic drug candidate from the il-2 based cue-100 series, designed to directly engage and activate t cells in the body to target hpv-driven cancers. the trial (nct03978689) is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of cue-101 as a monotherapy in patients with confirmed hpv16-driven recurrent/metastatic hnscc and hla-a*02:01 serotype. the study is designed to enroll approximately 50 patients. based on translational analysis/data from the trial, the company may expand the study to test cue-101 both as a neoadjuvant therapy and potentially in combination with checkpoint inhibitors in patients with hpv16-driven recurrent/metastatic hnscc. hpv-driven cancers account for more than 20,000 deaths each year in the u.s. and europe. the majority of these cancers are driven by hpv16 which carries the e7 antigen targeted by cue-101. despite treatment with current standards of care, approximately 50% of patients with advanced disease will experience recurrence and significant quality of life impact. patients with hpv-driven cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.
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