Bicara Therapeutics Launches Phase 3 FORTIFI-HN01 Trial and Raises $161.8M
Bicara Therapeutics selected a 1500mg weekly dose of ficerafusp alfa and initiated its Phase 3 FORTIFI-HN01 trial for first-line HPV-negative head and neck cancer, aiming for full enrollment by year-end and an interim analysis by mid-2027. An oversubscribed public offering raised $161.8 million, extending cash runway to H1 2029.
1. Dose Selection and Phase 3 Launch
Bicara selected 1500mg weekly as the optimal dose for ficerafusp alfa and has initiated the pivotal Phase 3 FORTIFI-HN01 trial in first-line recurrent or metastatic HPV-negative head and neck cancer. The company expects to substantially complete enrollment by year-end and plans an interim efficacy analysis by mid-2027.
2. Alternate Dosing Schedule Development
Based on phase 1b biomarker data, Bicara is developing an alternate regimen featuring a loading dose followed by every-three-week maintenance to maintain TGF-β inhibition and immune activation while improving patient convenience. Previous data demonstrated that 2000mg biweekly and 750mg weekly doses were well-tolerated with comparable response rates, supporting flexibility in dosing schedules.
3. Financial Position and Runway
An oversubscribed public offering generated $161.8 million in net proceeds, boosting cash, cash equivalents and marketable securities to $414.8 million as of December 31, 2025. Management projects this funding will support operations, clinical development and commercial preparation into the first half of 2029.