Cue Biopharma Reports Positive Preclinical Safety Data For CUE-401 In Autoimmune Development

Cue Biopharma, Inc, has announced new preclinical safety and tolerability data supporting the development of CUE-401, its lead autoimmune therapeutic candidate designed to selectively engage and modulate disease-specific T cells. The company conducted two separate non-GLP toxicology studies in mice and non-human primates (NHPs) to evaluate the safety profile of CUE-401. Both studies used a step-up dosing schedule, with animals receiving escalating intravenous doses weekly.

In the murine study (n=24; 12 males and 12 females), animals were administered increasing doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg. All dose levels were well tolerated, with no adverse events observed. In the NHP study (n=6; 3 males and 3 females), the core study involved escalating doses of 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg. These dose levels were also well tolerated, with no adverse findings.

“We are very encouraged with this preclinical data, which demonstrated that CUE-401 was well tolerated, and no adverse events were observed,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “Data generated from these preclinical studies represent an important addition to the growing evidence supporting the potential of CUE-401 as a first-in-class bifunctional tolerogenic agent for the treatment of autoimmune disease. We look forward to sharing further scientific data and details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months.”

Following confirmation of tolerability in the core study, a subset of animals received an additional dose one week later. Two animals (one male, one female) received 1 mg/kg, while four animals (two males, two females) received 3 mg/kg. The 1 mg/kg repeat dose was better tolerated than the 3 mg/kg repeat dose. The data further strengthen CUE-401's preclinical profile as the company advances the candidate toward potential clinical development in autoimmune and inflammatory diseases.