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Bicara Therapeutics
Bicara's lead drug, ficerafusp alfa, is a two-in-one antibody that blocks the EGFR growth signal on head and neck cancer cells while also soaking up TGF-beta, a molecule tumours use to suppress immune attack. It is in a pivotal trial with pembrolizumab in head and neck cancer.
Overview
Bicara Therapeutics is a Boston clinical-stage company developing bifunctional antibody therapies. Lead programme ficerafusp alfa (formerly BCA101) is an EGFR-directed monoclonal antibody fused to a human TGF-beta ligand trap, designed to block EGFR-driven proliferation while neutralising immunosuppressive TGF-beta in the tumour microenvironment. Three-year follow-up from a phase 1/1b cohort with pembrolizumab in first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma showed an estimated overall survival rate of 31% at the 1500 mg weekly dose. The pivotal FORTIFI-HN01 trial is enrolling, with topline results from an interim analysis expected in mid-2027, and the FORTIFI-FLEX alternate dosing study has started. Leadership transitions announced in August 2026 will see Ryan Cohlhepp become CEO in January 2027. Nasdaq: BCAX.
Headquarters
Boston, MA, US
Scorecard
All companies#341of 1244 companies, score 11
- phase 3 +3
- targets +2
- modalities +2
- registry trials +4
0 approved, 1 in phase 3, 0 earlier, 1 targets, 5 registry studies. Formula on the scorecards page.
Type
Biotech · BCAX
Stage
Public
Website
Phase 3Bifunctional antibody (EGFR × TGF-β trap)
Ficerafusp alfa is an EGFR antibody fused to a TGF-beta sponge, designed to remove the immune-suppressing signal that keeps HPV-negative throat cancers cold.
Notes
top- September 2024 IPO not sourced (8-K fetched did not state proceeds). Company website is JavaScript-rendered and returned little text.
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cancers
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technologies
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Phase 3Bifunctional antibody (EGFR × TGF-β trap)