KL-101 · Oncology
Head and neck squamous cell carcinoma
An investigational designed miniprotein that binds EGFR at the site its growth signals use. Now in a Phase 1 study.
- Target
- EGFR (ligand-binding domain III)
- Type
- De novo designed miniprotein
- Stage
- Phase 1
- Clinical trial
- KL101-001 (sample)Adults with recurrent or metastatic head and neck squamous cell carcinoma after standard therapy. Five sites in the United States.
Why this target
EGFR is a receptor on the cell surface. In most head and neck squamous cell cancers it is present at high levels, and its growth signal helps the tumor grow. An antibody that blocks EGFR (cetuximab) is approved, but many tumors grow again, and options after standard therapy remain limited.
Our approach
KL-101 is a small designed protein, about 7 kDa (an antibody is about 150 kDa). It binds domain III of EGFR, the same site the receptor’s natural signals (such as EGF) use. When KL-101 sits in that site, those signals cannot bind and switch the receptor on. Its small size may let it move deeper into tumor tissue. We are testing if that is true.
The study
The Phase 1 study tests safety and tolerability, and finds the dose for later studies. It is open at five sites in the United States.
KL-101 is investigational. It is not approved by the FDA or any other agency, and its safety and efficacy have not been established.
News and papers on KL-101
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.
PosterKL-101 blocks EGFR signaling in preclinical models of head and neck cancer
KL-101 binds EGFR domain III (KD 0.4 nM, SPR) and slowed tumor growth in mouse xenograft models. Preclinical data.
Press releaseIND for KL-101 now in effect
Keyline can now start the first clinical study of a protein it designed.
Work with us on a target.
We partner with drug companies on targets that are hard for their current tools.