CUE-101 gets fast tracked for recurrent/metastatic head and neck squamous cell carcinoma
Source: www.onclive.com Author: Kristi Rosa The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab (Keytruda) in patients with human papillomavirus (HPV16+) recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).1 CUE-101 is an off-the-shelf therapy that was designed to trigger and expand HPV16 tumor-specific T cells by exhibiting 2 cues to T cells. The first signal includes the HPV E7 protein, which is harbored by HPV-induced cancer cells and interacts with the HPV-specific T-cell receptor to offer selectivity. The second signal is comprised of an engineered interleukin-2 variant that fuels T cell activity. “We are very pleased to have received fast track designation from the FDA for CUE-101. This designation not only underscores the large unmet need for patients with recurrent/metastatic head and neck cancer who currently rely on available non-targeted therapies, but also highlights the potential of CUE-101 to provide a significant clinical benefit,” Matteo Levisetti, MD, senior vice president of Clinical Development at Cue Biopharma, Inc., stated in a press release. Previously, investigators evaluated the potential of CUE-101 to selectively activate and expand HPV16 E7–specific CD8-positive T cells in patients with HPV-driven cancers, including HNSCC, cervical cancer, and anal cancer.2 To showcase the activity of the product, human E7-specific T cells and peripheral blood mononuclear cells (PMBCs) were tested. To evaluate the in vivo activity of CUE-101, investigators evaluated the product in HLA-A2 transgenic mice. The agent was found to selectively bind, activate, and expand HPV16 [...]