Cue Biopharma, Inc.

Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologic drugs for oncology and immunology. As a standard part of its preclinical development process, the company conducts animal studies to assess the safety, tolerability, and efficacy of its drug candidates. For example, in February 2026, the company announced preclinical safety and tolerability data for its candidate CUE-401, which was derived from studies in animal models.

The company's research and development activities are subject to FDA regulations, which currently require animal testing for drug approval. While the FDA released a roadmap in April 2025 to eventually replace animal testing in preclinical studies, this transition to new approach methodologies (NAMs) is a long-term regulatory shift. For the foreseeable future, bringing a novel biologic therapy like Cue Biopharma's pipeline to market necessitates animal testing to meet regulatory requirements for investigational new drug (IND) applications and clinical trials.