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Cue Biopharma Doses First Patient in Phase I Trial of CUE-102 in WT1-Expressing Tumors

NEW YORK – Cue Biopharma on Monday said it has treated the first patient with Wilms' tumor 1 (WT1)-positive advanced cancer with its IL-2-targeted investigational therapy CUE-102.

The company hopes to enroll 52 patients with WT1-positive colorectal, gastric, pancreatic, and ovarian cancers in the two-part Phase I trial, in which it will characterize the safety and tolerability of CUE-102 and identify and evaluate anti-tumor activity of the recommended Phase II dose. In addition to having WT1-positive tumors, patients must also have the HLA-A*0201 genotype to participate in the trial.

"CUE-102 has the potential to activate the patient's immune system against numerous WT1-expressing cancers, including solid tumors and hematologic malignancies, and has demonstrated selective and significant activation of WT1-specific T cells in preclinical studies," Cue Biopharma acting Chief Medical Officer Ken Pienta said in a statement. "We believe that CUE-102 can play an important role in changing the treatment landscape for patients with WT1-positive cancers, by potentially delivering higher efficacy and lower toxicities than current available treatments."

In addition to CUE-102, Cue is developing another IL-2 targeted drug, its lead candidate CUE-101, in three clinical trials involving patients with HPV-positive head and neck cancers. One study is exploring CUE-101 as a monotherapy, another is evaluating CUE-101 with Merck's Keytruda (pembrolizumab), and a third is studying the drug as a neoadjuvant therapy in these patients.

Boston-based Cue used its Immuno-STAT platform to develop CUE-101, CUE-102, and another IL-2 targeting candidate in preclinical phase for KRAS-mutant cancers.