Press release ·
First patient dosed in the Phase 1 study of KL-101
Keyline's first clinical study is open in recurrent or metastatic head and neck cancer.
CAMBRIDGE, Mass., Sept. 15, 2026 · Keyline Bio today announced that the first patient received KL-101 in a Phase 1 study. KL-101 is an investigational miniprotein, designed by our model, that binds the ligand-binding site of EGFR.
“This is the first protein we designed from scratch to reach a clinical study,” said Dr. Maya Chen, chief executive officer. “We want to learn if a designed protein this small can block a target like EGFR in patients.”
About the study
The study enrolls adults with recurrent or metastatic head and neck squamous cell carcinoma after standard therapy. It tests safety and tolerability, finds the dose for later studies and looks for early signs of anti-tumor activity.
About KL-101
KL-101 binds domain III of EGFR, the site that the receptor’s natural signals use. KL-101 is investigational. Its safety and efficacy have not been established.
Forward-looking statements. This press release has forward-looking statements, such as plans for clinical studies, timing and the use of funds. They are based on what Keyline knows today and are subject to risks and uncertainties, so actual results can be different. Keyline does not have to update them. (Sample text for a demo site.)