Bicara Therapeutics

The company is a clinical-stage biopharmaceutical organization focused on targeting head and neck squamous cell cancer with its leading drug candidate, ficerafusp alfa, a bifunctional antibody designed to target solid tumors. Incorporated in Delaware, the company is currently evaluating ficerafusp alfa in an ongoing Phase 1/1b clinical trial in the U.S., aimed at treating patients with head and neck squamous cell cancer. Plans are underway to initiate a Phase 2/3 trial in late Q4 2024 or early Q1 2025 to assess ficerafusp alfa in combination with pembrolizumab as a first-line therapy for recurrent/metastatic head and neck squamous cell cancer. This trial will exclude patients associated with HPV infection or those who are HPV-positive with oropharyngeal squamous cell cancer.

The company also believes that ficerafusp alfa has the potential to offer meaningful clinical benefits in other solid tumors where there is a strong biological rationale for dual inhibition of both EGFR and TGF-b, such as in colorectal cancer and other squamous cell carcinomas, which typically overexpress the EGFR and TGF-b pathways. Preliminary activity of ficerafusp alfa has been demonstrated, both in combination with pembrolizumab and as a monotherapy, across several squamous cell carcinomas, including cutaneous squamous cell carcinoma (CSCC). In the Phase 1/1b dose expansion cohorts conducted in the U.S. and Canada, a preliminary overall response rate (ORR) of 42% (5 out of 12 patients) has been observed with ficerafusp alfa monotherapy in relapsed and/or refractory CSCC patients.