Cue Biopharma (CUE) Stifel 2024 Healthcare Conference summary

Platform and pipeline overview

• Modular platform enables targeted engagement of specific T cell populations for cancer and autoimmune diseases, with a focus on the CUE-100 and CUE-500 series.

• CUE-101 and CUE-102 are designed for selective activation of tumor-specific T cells, showing favorable tolerability and manufacturing advantages.

• CUE-500 series targets B cells by painting them with viral epitopes, redirecting antiviral T cells for cell depletion, applicable to both cancer and autoimmune indications.

• Partnerships with Ono for CUE-401 and CUE-501 support development and validation, with ongoing late-stage discussions for further collaborations.

• Emphasis on strategic partnerships that provide capital, development expertise, and asset retention rather than broad licensing.

Clinical data and competitive positioning

• CUE-101 monotherapy in advanced head and neck cancer shows median overall survival of 20.8 months, more than doubling historical controls.

• Combination of CUE-101 with pembrolizumab yields a 46% objective response rate and 91% 12-month survival, outperforming KEYNOTE-048 trial benchmarks.

• CUE-101 demonstrates efficacy in patients with low PD-L1 expression, with 100% one-year survival in this subgroup.

• CUE-102 shows favorable safety and early signs of activity across multiple solid tumors, with efficient clinical advancement due to molecular similarity with CUE-101.

• Competitive advantage is based on durable T cell responses and survival benefits, differentiating from bispecifics and other immunotherapies.

Autoimmune and preclinical programs

• CUE-401, partnered with Ono, induces regulatory T cells by concurrent IL-2 and TGF-beta engagement, showing strong preclinical efficacy and a favorable safety window.

• CUE-501 targets B cell depletion using viral epitope painting, aiming for a differentiated safety profile compared to CD3 bispecifics.

• Preclinical data support the mechanism and safety of both autoimmune programs, with lead candidate selection and IND strategy expected in Q1.

• Ono partnership structure includes subsidized preclinical work, opt-in rights, and potential co-development for U.S. rights, with key decisions anticipated in early Q2.

• Ongoing focus on building out the autoimmune pipeline while oncology data matures.