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FDA Accepts Cue Biopharma's IND for CUE-102 in WT1-Expressing Cancers

NEW YORK – Cue Biopharma said Wednesday that the US Food and Drug Administration has accepted its investigational new drug application to study CUE-102 as a treatment for patients with Wilms' tumor 1-positive recurrent or metastatic cancers.

The Boston-based firm will evaluate CUE-102, an interleukin-2-based biologic, in a Phase I dose escalation and expansion trial involving 52 participants with advanced colorectal, gastric, pancreatic, or ovarian cancer, who test positive for WT1, have an HLA-A*0201 genotype, and failed standard treatments. Researchers will evaluate the drug's safety, tolerability, and initial antitumor activity, among other parameters.

Cue's Immuno-STAT platform fuses IL-2 proteins designed to activate T cells with disease-specific activating or inhibitory proteins. CUE-102 comprises two human leukocyte antigen molecules presenting a WT1 peptide, four reduced affinity IL-2 molecules, and an effector attenuated human immunoglobulin G Fc domain.

The FDA's acceptance of its IND will allow Cue to begin treating patients in a clinical trial with a 1 mg/kg dose of CUE-102. The firm settled on this dosing based on the safety and tolerability data from a trial of its first product CUE-101, in which dosing was increased from 0.06 mg/kg to 1 mg/kg over a period of nine months. Having established that the 1 mg/kg dose was safe, the firm hopes to save time and money by starting patients on CUE-102 at the higher dose.

Cue is collaborating with Merck to develop CUE-101 in head and neck cancer. In January, Cue reported two objective responses in an interim update from a Phase I trial exploring CUE-101 with Merck's Keytruda (pembrolizumab) as a first-line therapy in patients with HPV-positive recurrent or metastatic head and neck cancer. In that same trial, the company is also testing CUE-101 alone in second- or later-line HPV-positive recurrent or metastatic head and neck cancer.