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Bicara Therapeutics (BCAX) investor relations material
Bicara Therapeutics Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status Update summary6 Dec, 2025
Clinical development and program highlights
Ficerafusp alfa (FICERA) is a bifunctional EGFR × TGF-β antibody, being studied in the pivotal FORTIFY-HN01 trial for first-line recurrent/metastatic HPV-negative HNSCC, and has received Breakthrough Therapy Designation in combination with pembrolizumab.
FICERA is designed to enable tumor penetration and prevent resistance, addressing a key challenge in solid tumor treatment.
The FORTIFY-HN01 trial uses a seamless Phase 2/3 design with dose optimization, comparing 750mg and 1,500mg doses of ficerafusp alfa plus pembrolizumab versus pembrolizumab monotherapy.
Dose selection for the pivotal trial is expected in Q1 2026, with both open-label Phase 1b cohorts informing the decision.
Phase 1b cohorts included patients with median age 64, majority with oral cavity as primary site, and CPS ≥1.
Market and disease context
HPV-negative R/M HNSCC represents about 80% of cases and is associated with poor prognosis and high therapeutic resistance.
The U.S. sees approximately 18,400 annual cases of HPV-negative R/M HNSCC, a sizable and growing market.
Overexpression of EGFR and TGF-β is characteristic of this tumor type, correlating with poor outcomes.
HNSCC incidence is rising globally, with up to 30% of advanced cases recurring or metastasizing after initial treatment.
HPV-negative R/M HNSCC patients face severe morbidities and have a critical need for durable anti-tumor therapies.
Efficacy and safety data
The 750mg dose cohort showed a 57% confirmed response rate and 83% disease control rate, with a 10% complete response rate and median time to response of 1.6 months.
Deep responses (≥80% tumor shrinkage) were observed in 29% of responders at 750mg, and 64% at 1,500mg at 24 weeks.
Both 750mg and 1,500mg doses demonstrated high ORR (57% and 54%, respectively), outperforming pembrolizumab monotherapy.
Safety profile for both doses was manageable, with low-grade adverse events, low discontinuation rates, and no treatment-related deaths; higher anemia rates were seen at 1,500mg but were manageable.
Discontinuation due to adverse events was low (6%).
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Next Bicara Therapeutics earnings date
44th Annual J.P. Morgan Healthcare Conference12 Jan, 2026
Next Bicara Therapeutics earnings date
44th Annual J.P. Morgan Healthcare Conference12 Jan, 2026
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Frequently asked questions
Bicara Therapeutics Inc. is a biopharmaceutical company focused on developing innovative immuno-oncology therapies for cancer treatment. The company specializes in creating biologics that combine tumor-targeting properties with immune modulation to improve treatment outcomes for patients with advanced or resistant cancers. Bicara’s research and development efforts are geared toward creating therapies that harness the body’s immune system to selectively target and combat cancer cells. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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