Arcus Biosciences has received regulatory approval to commence a Phase l trial to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AB154 as a monotherapy and in combination with AB122 for the treatment of tumour types associated with high levels of T-cell immunoreceptor with Ig and ITIM (TIGIT) domains.
The dose-escalation portion of the multi-centre, open-label trial will initially evaluate increasing doses of AB154 as a monotherapy and then in combination with AB122s.
After determining the recommended doses for AB154 as a monotherapy and in combination with AB122, the trial is expected to include an expansion cohort to analyse AB154 as a monotherapy and in combination with AB122 in selected tumour types.
In addition, Arcus intends to explore AB154 in combination with its other product candidates.
The company plans to begin dosing patients in the Phase l trial soon, with an aim to add Australia as the trial’s initial site.
It is also preparing to submit an investigational new drug (IND) application with the US Food and Drug Administration (FDA) in the last quarter of this year to commence this trial in the US.
Preliminary results from the dose-escalation portion of the trial are expected to be available next year.
Arcus Biosciences CEO Terry Rosen said: “The initiation of clinical testing for AB154 represents another significant milestone for the company, as we believe that anti-TIGIT antibodies have the potential to be a new and important class of backbone therapy in immuno-oncology.
“TIGIT is a unique immune checkpoint target, because it is involved in a pathway that plays both immune inhibitory and stimulatory roles in the tumour microenvironment.
“Our clinical programme for AB154 will focus on tumour types associated with high levels of TIGIT or CD155, the primary ligand for TIGIT.”
AB154 is a monoclonal antibody designed to potently and selectively block the TIGIT immune checkpoint.