Pipeline

Cue Biopharma is working at the cutting edge of the immunotherapy revolution, with the potential to offer patients breakthrough therapeutic advantages while minimizing, or possibly eliminating unwanted side effects. Our vision is to transform medicine by realizing the promise of safe and highly effective immunotherapy. We aim to achieve this through the development of our Immuno-STAT and Neo-STAT biologics platforms engineered to overcome the current challenges faced by prevailing immuno-therapeutics. Our biologics are designed to selectively engage and modulate disease relevant T cells by emulating nature’s own “cues”, or signals, to regulate the immune system. These biologics are administered directly in the patient’s body, with the aim of enabling the patient’s own immune system to achieve balance and restore health.

In September 2019, we commenced our first-in-human, dose-escalation and expansion Phase 1 clinical trial of CUE-101 in patients with HPV-positive recurrent or metastatic head and neck squamous cell carcinoma (NCT03978689). In February 2021, we commenced a dose-escalation and expansion Phase 1 clinical trial of CUE-101 in combination with KEYTRUDA® (pembrolizumab) in newly diagnosed patients with HPV-positive recurrent or metastatic head and neck squamous cell carcinoma. Cue Biopharma has engaged a network of nationally recognized clinical investigators at 14 top-tier institutions that are actively recruiting patients.

CUE Pipeline