Bicara Therapeutics Highlights Broad Potential of Ficerafusp Alfa at AACR Annual Meeting 2025

Core Viewpoint - Bicara Therapeutics Inc. is advancing its lead product, ficerafusp alfa, a bifunctional antibody targeting EGFR and TGF-β, showing promising results in treating solid tumors, particularly in head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma [1][2][9] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [9] - The company aims to address significant unmet needs in cancer treatment, particularly in patients with advanced or metastatic diseases [4][9] Product Development - Ficerafusp alfa is a first-in-class bifunctional antibody that combines an EGFR-directed monoclonal antibody with a TGF-β binding domain, potentially enhancing anti-tumor activity by targeting both cancer cell survival and immunosuppressive signaling [7][9] - The drug is currently being evaluated in pivotal Phase 2/3 clinical trials for first-line recurrent/metastatic head and neck squamous cell carcinoma [8] Clinical Data Highlights - Recent presentations at the AACR Annual Meeting 2025 showcased data supporting ficerafusp alfa's ability to block TGF-β signaling, which may prevent resistance mechanisms in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma [2][3] - In a Phase 1/1b trial for second-line metastatic cutaneous squamous cell carcinoma, ficerafusp alfa demonstrated an overall response rate of 30.4% and a clinical benefit rate of 82.6%, with a median progression-free survival of 7.0 months [3][4] - The drug also showed potential in reversing acquired resistance to KRAS G12C inhibitors in KRAS G12C-mutant lung cancer, indicating its broad therapeutic potential [5][11] Market Context - Cutaneous squamous cell carcinoma is the second most common skin cancer, with rising incidence highlighting the need for effective treatment options, especially for patients who progress on anti-PD-1 therapies [4][6] - The lack of approved second-line therapies for patients with advanced or metastatic cutaneous squamous cell carcinoma underscores the importance of ficerafusp alfa's development [4][6]