# Bicara Therapeutics

Source: https://onco.cc/companies/bicara-therapeutics/  
OnCo record `bicara-therapeutics` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Company
- Last checked: 2026-09-10
- HQ: Boston, MA
- Type: biotech
- Website: https://www.bicara.com/
- Ticker: BCAX

## Notes

- September 2024 IPO not sourced (8-K fetched did not state proceeds). Company website is JavaScript-rendered and returned little text.

## Sources

- Official website: https://www.bicara.com/
- Q2 2026 results and leadership transition (8-K exhibit 99.1): https://www.sec.gov/Archives/edgar/data/2023658/000162828026055500/projectwaystar-2q26earning.htm

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Ficerafusp alfa](https://onco.cc/drugs/ficerafusp-alfa/)
- trials: [A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC](https://onco.cc/trials/nct07807163/), [FORTIFI-HN01](https://onco.cc/trials/fortifi-hn01/)

---
JSON: https://onco.cc/api/v1/entities/bicara-therapeutics.json