{"entity":{"id":"bicara-therapeutics","kind":"company","name":"Bicara Therapeutics","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-10","links":[{"label":"Official website","url":"https://www.bicara.com/"},{"label":"Q2 2026 results and leadership transition (8-K exhibit 99.1)","url":"https://www.sec.gov/Archives/edgar/data/2023658/000162828026055500/projectwaystar-2q26earning.htm"}],"tags":[],"related":[],"cancers":["head-and-neck"],"sections":["immunotherapy"],"technologies":["bispecific-antibody","monoclonal-antibody"],"targets":["egfr"],"drugs":["ficerafusp-alfa"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct07807163"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["September 2024 IPO not sourced (8-K fetched did not state proceeds). Company website is JavaScript-rendered and returned little text."],"hq":"Boston, MA","country":"US","companyType":"biotech","website":"https://www.bicara.com/","ticker":"BCAX","stage":"public","investors":[],"funding":[]},"route":"/companies/bicara-therapeutics/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"ficerafusp-alfa","kind":"drug","name":"Ficerafusp alfa","route":"/drugs/ficerafusp-alfa/"}],"trial":[{"id":"nct07807163","kind":"trial","name":"A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC","route":"/trials/nct07807163/"},{"id":"fortifi-hn01","kind":"trial","name":"FORTIFI-HN01","route":"/trials/fortifi-hn01/"}]}}