The US Food and Drug Administration (FDA) has granted clearance for Sensei Biotherapeutics’ investigational new drug (IND) application for SNS-101 enabling the initiation of a Phase I/II clinical trial to treat solid tumours.

The efficacy of SNS-101 as both a monotherapy and along with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) will be assessed in the study.

The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics properties of SNS-101.

Patients will be administered an intravenous infusion of SNS-101 once every three weeks.

Sensei Biotherapeutics president and CEO John Celebi said: “Receiving IND clearance to advance our first conditionally active antibody into a Phase 1/2 clinical trial represents an important milestone for Sensei.

“We believe that SNS-101 has the potential to make a significant impact in the field and to improve the lives of cancer patients worldwide.

“We are delighted to bring SNS-101 into the clinic and explore its potential as a transformative treatment option for patients with solid tumours.”

The first patient of the Phase I/II study is expected to be dosed in the middle of this year.

The study’s Phase I dose escalation part will be followed by an expansion Phase II in selected patients on determining a recommended dose for Phase II .

SNS-101, a conditionally active, human monoclonal IgG1 antibody, selectively blocks the VISTA checkpoint in the tumour microenvironment.