Cue Biopharma (CUE) Jefferies 2024 Global Healthcare Conference summary

Platform overview and scientific approach

• Focus on selective modulation of disease-relevant immune cells to restore immune balance and preserve safety.

• Oncology programs enhance tumor antigen-specific T cells, while autoimmune programs induce regulatory T cells or deplete pathogenic B cells.

• Platform uses antibody Fc scaffolds to directly engage T cell receptors, bypassing antigen-presenting cells and minimizing broad immune activation.

Oncology program highlights

• CUE-101 targets HPV-specific T cells in head and neck cancer, showing median overall survival of ~21 months in late-stage patients, compared to 7.5–8.5 months for standard treatments.

• Combination with Keytruda in frontline setting yields a 46% response rate, over double that of Keytruda alone, with notable efficacy in both CPS high and low patients.

• Progression-free survival is 5.8 months (vs. 3.2 months for Keytruda), and 12-month overall survival is estimated at 96%.

• CUE-102, targeting Wilms' tumor 1, shows selective T cell expansion and tumor reduction in refractory cancers, with -34% and -30% lesion reductions in gastric and ovarian cancer patients.

• Platform modularity enables rapid development and regulatory efficiencies for new candidates targeting various tumor antigens.

Regulatory and clinical development

• FDA allowed CUE-102 to proceed without additional toxicology, leveraging CUE-101 data, and start at a clinically active dose, saving significant development time.

• Productive FDA discussions led to alignment on registration path and trial design, including a phase 2 trial comparing two CUE-101 doses plus pembro versus pembro alone.

• Phase 2 trial will enroll about 25 patients per arm, with strong basis for phase 3 if signals hold.

• CUE-102 dose expansion will enroll 28 colorectal cancer patients, with a comprehensive data update planned for SITC in the second half of the year.