Bicara Therapeutics Inc.

We are a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors. Our platform is designed to create therapies that precisely target tumors and deliver a tumor-modulating payload directly to the tumor site. This dual-targeting method aims to increase drug exposure within the tumor microenvironment (TME) while limiting side effects throughout the body. Our primary product is ficerafusp alfa (formerly BCA101), a bifunctional monoclonal antibody. It targets the epidermal growth factor receptor (EGFR) and is linked to a human transforming growth factor beta (TGF-β) ligand trap. Ficerafusp alfa aims to block both EGFR-driven cancer cell survival and proliferation, and the immunosuppressive TGF-β signaling within the TME. By binding to EGFR on tumor cells, ficerafusp alfa directs the TGF-β inhibitor into the immediate TME. We are concentrating our efforts on developing ficerafusp alfa for solid tumors where there is a strong biological reason for inhibiting both EGFR and TGF-β, such as head and neck cancers and other squamous cell carcinomas that typically overexpress EGFR and TGF-β pathways. Ficerafusp alfa is currently being studied in head and neck squamous cell carcinoma (HNSCC). Our global, double-blind, Phase 2/3 FORTIFI-HN01 pivotal trial is ongoing. This trial evaluates 1500mg of ficerafusp alfa dosed once weekly (QW) in combination with pembrolizumab in first-line (1L) recurrent/metastatic (R/M) human papillomavirus infection (HPV)-negative HNSCC, specifically in patients whose tumors express programmed death-ligand 1 with a combined positive score (CPS) of ≥1.