Cue Biopharma, Inc. announced that the U.S. food and drug administration (FDA) has accepted the company's investigational new drug (IND) application for the evaluation of CUE-102, its second interleukin 2 (IL-2)-based CUE-100 series biologic, in a dose escalation and expansion monotherapy Phase 1 trial, which will have a starting dose of 1 mg/kg for the treatment of Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers, with initial focus on gastric, pancreatic, ovarian and colon cancers. CUE-102 supports the modularity of the IL-2 based CUE-100 series as the core biologic framework is largely conserved with the primary difference being the incorporation of the WT1 T cell epitope. The IND acceptance allowing the dose escalation trial to begin dosing at 1 mg/kg was supported by the safety and tolerability data from the CUE-101 trial.

CUE-101, the first biologic from the CUE-100 series, had a starting dose of 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. As such, the starting dose of CUE-102 (targeting WT1 expressing cancers) may provide substantive time and cost savings for potentially demonstrating tolerability at therapeutically effective doses.