Bicara Therapeutics (BCAX) Piper Sandler 37th Annual Healthcare Conference summary

Program overview and clinical progress

• Focus on developing multifunctional agents for solid tumors, with lead program ficerafusp alfa targeting TGF-β and EGFR in head and neck cancer.

• Phase II/III pivotal trial initiated in February, following promising data from ASCO 2023 and two-year follow-up.

• Recent data show substantial improvements in response rate, progression-free survival, duration of response, and overall survival.

• EGFR delivers response rate, while TGF-β contributes to depth and durability of response.

• Clear differentiation of TGF-β's clinical benefit established through translational and clinical data.

Dose optimization and safety

• Both 750 mg and 1,500 mg doses included in pivotal trial, with dose selection planned for first half of 2026.

• 750 mg saturates EGFR target, showing a 55% confirmed response rate, similar to 1,500 mg.

• Higher complete response rate observed at 1,500 mg, attributed to greater TGF-β inhibition.

• Bleeding events are transient and low grade; anemia more frequent at higher dose but manageable.

• Dose selection will be disclosed without unblinding efficacy data to maintain trial integrity.

Trial design and regulatory strategy

• Seamless phase II/III design allows dose selection and efficacy analysis within a single trial.

• Accelerated approval possible based on overall response rate at 350 events, with confirmatory overall survival endpoint.

• Expansion cohort at 2,000 mg Q2W aims to enable less frequent dosing and synchronize with pembro administration.

• Pharmacokinetic bridging studies planned in parallel to support future label expansion.